Trial Outcomes & Findings for A Proof-of-principle Study of HBO-SRS for Brain Metastases (NCT NCT01850563)

Last Updated: 2022-02-08

Results Overview

Time from end of HBO decompression to start of SRS treatment will be measured to determine feasibility. Feasibility is defined as having been achieved if more than 50% of the 20 evaluable patients start SRS treatment within 30 minutes of leaving the HBO tank

Recruitment status

COMPLETED

Study phase

Target enrollment

22 participants

Primary outcome timeframe

Approximately 30 minutes during SRS Treatment Visit

Results posted on

2022-02-08

Participant Flow

HBO feasibility subjects were recruited from potential candidates for stereotactic radiosurgery (SRS) treatment at DHMC for brain metastases. Such patients are referred to radiation oncology by practitioners at DHMC and by physicians at outlying hospitals. Historic Controls: Retrospective review of previous patients utilizing SRS in the treatment of brain metastases. The control population was selected based on matching variables.

Adverse events were not collected for historic controls.

Participant milestones

Participant milestones
Measure	HBO Feasibility Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO	Historic Controls Retrospective review of previous patients utilizing SRS in the treatment of brain metastases. The matching variables (histology, lesion size, resection status, and calculated GPA) will be used to identify this control population.
Overall Study STARTED	22	19
Overall Study HBO Treatment Completed	19	0
Overall Study COMPLETED	19	19
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	HBO Feasibility Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO	Historic Controls Retrospective review of previous patients utilizing SRS in the treatment of brain metastases. The matching variables (histology, lesion size, resection status, and calculated GPA) will be used to identify this control population.
Overall Study Not eligible	3	0

Baseline Characteristics

A Proof-of-principle Study of HBO-SRS for Brain Metastases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HBO Feasibility n=22 Participants Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO. Demographic information (Race, gender, ethnicity, and age) were collected for only the participants who were prospectively enrolled and provided informed consent.	Historic Controls n=19 Participants Retrospective review of previous patients utilizing SRS in the treatment of brain metastases. The matching variables (histology, lesion size, resection status, and calculated GPA) will be used to identify this control population.	Total n=41 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	10 Participants n=7 Participants	26 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants	0 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	0 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	19 participants n=7 Participants	41 participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 30 minutes during SRS Treatment Visit

Population: Three (3) participants were screen failures, and did not receive study treatment, and not included in the analysis.

Outcome measures

Outcome measures
Measure	HBO Feasibility n=19 Participants Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO	Historic Controls Retrospective review of previous patients utilizing SRS in the treatment of brain metastases. The matching variables (histology, lesion size, resection status, and calculated GPA) will be used to identify this control population.
The Average Time From HBO Chamber Exit to SRS beam-on	8.3 minutes Interval 5.0 to 12.0	—

SECONDARY outcome

Timeframe: 5 year from treatment

Population: Three (3) participants were screen failures, and did not receive study treatment, and not included in the analysis.

Median time to death

Outcome measures

Outcome measures
Measure	HBO Feasibility n=19 Participants Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO	Historic Controls n=19 Participants Retrospective review of previous patients utilizing SRS in the treatment of brain metastases. The matching variables (histology, lesion size, resection status, and calculated GPA) will be used to identify this control population.
Overall Survival in Years	1.42 Years Interval 0.96 to 2.35	1.03 Years Interval 0.57 to 2.8

SECONDARY outcome

Timeframe: 5 year from treatment

Population: Three (3) participants were screen failures, and did not receive study treatment, and not included in the analysis.

Number of years until recurrence of lesion

Outcome measures

Outcome measures
Measure	HBO Feasibility n=19 Participants Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO	Historic Controls n=19 Participants Retrospective review of previous patients utilizing SRS in the treatment of brain metastases. The matching variables (histology, lesion size, resection status, and calculated GPA) will be used to identify this control population.
Number of Years Until Local Recurrence	NA Years Interval 1.45 to Insufficient data (only one observed occurrence)	NA Years Interval 0.7 to Insufficient data (only one observed occurrence)

SECONDARY outcome

Timeframe: 5 year from treatment

Population: Three (3) participants were screen failures, and did not receive study treatment, and not included in the analysis.

Number of years until local recurrence of lesion prior to whole brain radiation therapy

Outcome measures

Outcome measures
Measure	HBO Feasibility n=19 Participants Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO	Historic Controls n=19 Participants Retrospective review of previous patients utilizing SRS in the treatment of brain metastases. The matching variables (histology, lesion size, resection status, and calculated GPA) will be used to identify this control population.
Number of Years Until Local Recurrence Prior to WBRT	NA Years Interval 1.45 to Insufficient data (only one observed occurrence)	NA Years Interval 0.7 to Insufficient data (only one observed occurrence)

SECONDARY outcome

Timeframe: 5 year from treatment

Population: Three (3) participants were screen failures, and did not receive study treatment, and not included in the analysis.

Number of participants who developed intercranial distant recurrence

Outcome measures

Outcome measures
Measure	HBO Feasibility n=19 Participants Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO	Historic Controls n=19 Participants Retrospective review of previous patients utilizing SRS in the treatment of brain metastases. The matching variables (histology, lesion size, resection status, and calculated GPA) will be used to identify this control population.
Number of Participants Developing Intercranial Distant Recurrence	9 Participants	11 Participants

SECONDARY outcome

Timeframe: 5 year from treatment

Population: Three (3) participants were screen failures, and did not receive study treatment, and not included in the analysis. 17 participants in the HBO group, and 14 historical controls did not receive whole brain radiation therapy

Outcome measures

Outcome measures
Measure	HBO Feasibility n=2 Participants Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO	Historic Controls n=5 Participants Retrospective review of previous patients utilizing SRS in the treatment of brain metastases. The matching variables (histology, lesion size, resection status, and calculated GPA) will be used to identify this control population.
Number of Months Between SRS Treatment and Whole Brain Radiation Therapy	8.5 Months Interval 1.5 to 23.3	5.6 Months Interval 4.7 to 6.5

SECONDARY outcome

Timeframe: 5 year from treatment

Population: Three (3) participants were screen failures, and did not receive study treatment, and not included in the analysis.

Outcome measures

Outcome measures
Measure	HBO Feasibility n=25 Lesions Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO	Historic Controls n=27 Lesions Retrospective review of previous patients utilizing SRS in the treatment of brain metastases. The matching variables (histology, lesion size, resection status, and calculated GPA) will be used to identify this control population.
Number of Lesions Exhibiting Radionecrosis	5 Lesions exhibiting radionecrosis	6 Lesions exhibiting radionecrosis

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 4 to 6 weeks after treatment and then every 3 months for a minimum of 1 year, up to 5 years

Population: Three (3) participants were screen failures, and did not receive study treatment, and not included in the analysis. This information was not available for historical controls.

SLUMS is an 11-item screening tool to evaluate cognitive ability in adults. The SLUMS score ranges from 1-30. For patients with a high school education, the normal range score is 27-30. For mild neurocognitive disorder, the score range is 21-26. Dementia range is 1-20. For patients with less than a high school education the normal range score is 25-30. For mild neurocognitive disorder, the score range is 20-24. Dementia range is 1-19. The scores across all time points were averaged to obtain the mean.

Outcome measures

Outcome measures
Measure	HBO Feasibility n=19 Participants Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO	Historic Controls Retrospective review of previous patients utilizing SRS in the treatment of brain metastases. The matching variables (histology, lesion size, resection status, and calculated GPA) will be used to identify this control population.
Average Score of Quality of Life as Measured by St. Louis University Mental Status Exam (SLUMS) Mental Status Exam (SLUMS)	26.5 units on a scale Standard Deviation 3.4	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 4 to 6 weeks after treatment and then every 3 months for a minimum of 1 year, up to 5 years

Population: Three (3) participants were screen failures, and did not receive study treatment, and not included in the analysis. This information was not available for historical controls.

Averages score QL2 determined by responses to aggregate combined results of questionnaires (QLQ C-30 and BN-20). EORTC Quality of Life Questionnaire C-30 (QLQ C-30): 30-item self-report questionnaire rating items on a 4-point scale (1 "not at all" to 4 "very much") It measures several domains (physical, role, emotional, cognitive, and social functioning, fatigue, pain, nausea and vomiting) and several single items. Scores are averaged for each scale and transformed to 0-100 scale; higher score indicates better QoL on global health status and functional scales and worse QoL on symptom scales and financial difficulty scale. EORTC QLQ BN-20 (BN-20): 4 scales comprised of multiple items and 7 single items. All items are rated on a 4-point Likert-type scale, 1=not at all' to 4=very much, and linearly transformed to a 0-100 scale, higher scores indicating more severe symptoms. The scores across all time points were averaged to obtain the mean.

Outcome measures

Outcome measures
Measure	HBO Feasibility n=19 Participants Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO	Historic Controls Retrospective review of previous patients utilizing SRS in the treatment of brain metastases. The matching variables (histology, lesion size, resection status, and calculated GPA) will be used to identify this control population.
Average Score of EORTC Global Health Status (QL2)	66.8 score on a scale Standard Deviation 24.6	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 24-48 hours after the SRS treatment

Population: Sample donations where optional for the study participants. Insufficient samples were obtained and therefore, samples were not analyzed.

Serum markers for tissue apoptosis and for neuronal damage

Outcome measures

Outcome data not reported

Adverse Events

HBO Feasibility

Serious events: 0 serious events

Other events: 5 other events

Deaths: 8 deaths

Historic Controls

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	HBO Feasibility n=19 participants at risk Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO	Historic Controls n=19 participants at risk Retrospective review of previous patients utilizing SRS in the treatment of brain metastases. The matching variables (histology, lesion size, resection status, and calculated GPA) will be used to identify this control population.
Nervous system disorders Headache	15.8% 3/19 • Number of events 3 • Adverse events (AE) for the HBO Feasibility arm will be collected during the period from the initiation of the study procedures until the date of documented death, withdrawal of consent, or the end of the study, whichever occurs first. Collection could span approximately 5 years. Adverse events were not collected for the historic controls. Symptomatic treatment toxicity: AEs potentially related to intracranial SRS and/or HBO treatments Radiographic evidence for radionecrosis/treatment effects in normal tissue identified by diagnostic radiologist of follow-up MRI imaging. Incidence of WBRT, Incidence of repeat SRS to the index site and a distant site. Local and distant disease recurrence at the treatment site identified by diagnostic radiologist of follow-up MRI imaging. AEs were not collected for historic controls.	10.5% 2/19 • Number of events 2 • Adverse events (AE) for the HBO Feasibility arm will be collected during the period from the initiation of the study procedures until the date of documented death, withdrawal of consent, or the end of the study, whichever occurs first. Collection could span approximately 5 years. Adverse events were not collected for the historic controls. Symptomatic treatment toxicity: AEs potentially related to intracranial SRS and/or HBO treatments Radiographic evidence for radionecrosis/treatment effects in normal tissue identified by diagnostic radiologist of follow-up MRI imaging. Incidence of WBRT, Incidence of repeat SRS to the index site and a distant site. Local and distant disease recurrence at the treatment site identified by diagnostic radiologist of follow-up MRI imaging. AEs were not collected for historic controls.
Nervous system disorders Seizure	10.5% 2/19 • Number of events 2 • Adverse events (AE) for the HBO Feasibility arm will be collected during the period from the initiation of the study procedures until the date of documented death, withdrawal of consent, or the end of the study, whichever occurs first. Collection could span approximately 5 years. Adverse events were not collected for the historic controls. Symptomatic treatment toxicity: AEs potentially related to intracranial SRS and/or HBO treatments Radiographic evidence for radionecrosis/treatment effects in normal tissue identified by diagnostic radiologist of follow-up MRI imaging. Incidence of WBRT, Incidence of repeat SRS to the index site and a distant site. Local and distant disease recurrence at the treatment site identified by diagnostic radiologist of follow-up MRI imaging. AEs were not collected for historic controls.	5.3% 1/19 • Number of events 1 • Adverse events (AE) for the HBO Feasibility arm will be collected during the period from the initiation of the study procedures until the date of documented death, withdrawal of consent, or the end of the study, whichever occurs first. Collection could span approximately 5 years. Adverse events were not collected for the historic controls. Symptomatic treatment toxicity: AEs potentially related to intracranial SRS and/or HBO treatments Radiographic evidence for radionecrosis/treatment effects in normal tissue identified by diagnostic radiologist of follow-up MRI imaging. Incidence of WBRT, Incidence of repeat SRS to the index site and a distant site. Local and distant disease recurrence at the treatment site identified by diagnostic radiologist of follow-up MRI imaging. AEs were not collected for historic controls.
Nervous system disorders Cognitive Disturbance	5.3% 1/19 • Number of events 1 • Adverse events (AE) for the HBO Feasibility arm will be collected during the period from the initiation of the study procedures until the date of documented death, withdrawal of consent, or the end of the study, whichever occurs first. Collection could span approximately 5 years. Adverse events were not collected for the historic controls. Symptomatic treatment toxicity: AEs potentially related to intracranial SRS and/or HBO treatments Radiographic evidence for radionecrosis/treatment effects in normal tissue identified by diagnostic radiologist of follow-up MRI imaging. Incidence of WBRT, Incidence of repeat SRS to the index site and a distant site. Local and distant disease recurrence at the treatment site identified by diagnostic radiologist of follow-up MRI imaging. AEs were not collected for historic controls.	15.8% 3/19 • Number of events 3 • Adverse events (AE) for the HBO Feasibility arm will be collected during the period from the initiation of the study procedures until the date of documented death, withdrawal of consent, or the end of the study, whichever occurs first. Collection could span approximately 5 years. Adverse events were not collected for the historic controls. Symptomatic treatment toxicity: AEs potentially related to intracranial SRS and/or HBO treatments Radiographic evidence for radionecrosis/treatment effects in normal tissue identified by diagnostic radiologist of follow-up MRI imaging. Incidence of WBRT, Incidence of repeat SRS to the index site and a distant site. Local and distant disease recurrence at the treatment site identified by diagnostic radiologist of follow-up MRI imaging. AEs were not collected for historic controls.
Nervous system disorders Memory Impairment	10.5% 2/19 • Number of events 2 • Adverse events (AE) for the HBO Feasibility arm will be collected during the period from the initiation of the study procedures until the date of documented death, withdrawal of consent, or the end of the study, whichever occurs first. Collection could span approximately 5 years. Adverse events were not collected for the historic controls. Symptomatic treatment toxicity: AEs potentially related to intracranial SRS and/or HBO treatments Radiographic evidence for radionecrosis/treatment effects in normal tissue identified by diagnostic radiologist of follow-up MRI imaging. Incidence of WBRT, Incidence of repeat SRS to the index site and a distant site. Local and distant disease recurrence at the treatment site identified by diagnostic radiologist of follow-up MRI imaging. AEs were not collected for historic controls.	10.5% 2/19 • Number of events 2 • Adverse events (AE) for the HBO Feasibility arm will be collected during the period from the initiation of the study procedures until the date of documented death, withdrawal of consent, or the end of the study, whichever occurs first. Collection could span approximately 5 years. Adverse events were not collected for the historic controls. Symptomatic treatment toxicity: AEs potentially related to intracranial SRS and/or HBO treatments Radiographic evidence for radionecrosis/treatment effects in normal tissue identified by diagnostic radiologist of follow-up MRI imaging. Incidence of WBRT, Incidence of repeat SRS to the index site and a distant site. Local and distant disease recurrence at the treatment site identified by diagnostic radiologist of follow-up MRI imaging. AEs were not collected for historic controls.
Nervous system disorders Dysarthria	0.00% 0/19 • Adverse events (AE) for the HBO Feasibility arm will be collected during the period from the initiation of the study procedures until the date of documented death, withdrawal of consent, or the end of the study, whichever occurs first. Collection could span approximately 5 years. Adverse events were not collected for the historic controls. Symptomatic treatment toxicity: AEs potentially related to intracranial SRS and/or HBO treatments Radiographic evidence for radionecrosis/treatment effects in normal tissue identified by diagnostic radiologist of follow-up MRI imaging. Incidence of WBRT, Incidence of repeat SRS to the index site and a distant site. Local and distant disease recurrence at the treatment site identified by diagnostic radiologist of follow-up MRI imaging. AEs were not collected for historic controls.	5.3% 1/19 • Number of events 1 • Adverse events (AE) for the HBO Feasibility arm will be collected during the period from the initiation of the study procedures until the date of documented death, withdrawal of consent, or the end of the study, whichever occurs first. Collection could span approximately 5 years. Adverse events were not collected for the historic controls. Symptomatic treatment toxicity: AEs potentially related to intracranial SRS and/or HBO treatments Radiographic evidence for radionecrosis/treatment effects in normal tissue identified by diagnostic radiologist of follow-up MRI imaging. Incidence of WBRT, Incidence of repeat SRS to the index site and a distant site. Local and distant disease recurrence at the treatment site identified by diagnostic radiologist of follow-up MRI imaging. AEs were not collected for historic controls.
Nervous system disorders Ataxia	5.3% 1/19 • Number of events 1 • Adverse events (AE) for the HBO Feasibility arm will be collected during the period from the initiation of the study procedures until the date of documented death, withdrawal of consent, or the end of the study, whichever occurs first. Collection could span approximately 5 years. Adverse events were not collected for the historic controls. Symptomatic treatment toxicity: AEs potentially related to intracranial SRS and/or HBO treatments Radiographic evidence for radionecrosis/treatment effects in normal tissue identified by diagnostic radiologist of follow-up MRI imaging. Incidence of WBRT, Incidence of repeat SRS to the index site and a distant site. Local and distant disease recurrence at the treatment site identified by diagnostic radiologist of follow-up MRI imaging. AEs were not collected for historic controls.	0.00% 0/19 • Adverse events (AE) for the HBO Feasibility arm will be collected during the period from the initiation of the study procedures until the date of documented death, withdrawal of consent, or the end of the study, whichever occurs first. Collection could span approximately 5 years. Adverse events were not collected for the historic controls. Symptomatic treatment toxicity: AEs potentially related to intracranial SRS and/or HBO treatments Radiographic evidence for radionecrosis/treatment effects in normal tissue identified by diagnostic radiologist of follow-up MRI imaging. Incidence of WBRT, Incidence of repeat SRS to the index site and a distant site. Local and distant disease recurrence at the treatment site identified by diagnostic radiologist of follow-up MRI imaging. AEs were not collected for historic controls.
Psychiatric disorders Anxiety	10.5% 2/19 • Number of events 2 • Adverse events (AE) for the HBO Feasibility arm will be collected during the period from the initiation of the study procedures until the date of documented death, withdrawal of consent, or the end of the study, whichever occurs first. Collection could span approximately 5 years. Adverse events were not collected for the historic controls. Symptomatic treatment toxicity: AEs potentially related to intracranial SRS and/or HBO treatments Radiographic evidence for radionecrosis/treatment effects in normal tissue identified by diagnostic radiologist of follow-up MRI imaging. Incidence of WBRT, Incidence of repeat SRS to the index site and a distant site. Local and distant disease recurrence at the treatment site identified by diagnostic radiologist of follow-up MRI imaging. AEs were not collected for historic controls.	0.00% 0/19 • Adverse events (AE) for the HBO Feasibility arm will be collected during the period from the initiation of the study procedures until the date of documented death, withdrawal of consent, or the end of the study, whichever occurs first. Collection could span approximately 5 years. Adverse events were not collected for the historic controls. Symptomatic treatment toxicity: AEs potentially related to intracranial SRS and/or HBO treatments Radiographic evidence for radionecrosis/treatment effects in normal tissue identified by diagnostic radiologist of follow-up MRI imaging. Incidence of WBRT, Incidence of repeat SRS to the index site and a distant site. Local and distant disease recurrence at the treatment site identified by diagnostic radiologist of follow-up MRI imaging. AEs were not collected for historic controls.
Nervous system disorders Intercranial hemorrhage	5.3% 1/19 • Number of events 1 • Adverse events (AE) for the HBO Feasibility arm will be collected during the period from the initiation of the study procedures until the date of documented death, withdrawal of consent, or the end of the study, whichever occurs first. Collection could span approximately 5 years. Adverse events were not collected for the historic controls. Symptomatic treatment toxicity: AEs potentially related to intracranial SRS and/or HBO treatments Radiographic evidence for radionecrosis/treatment effects in normal tissue identified by diagnostic radiologist of follow-up MRI imaging. Incidence of WBRT, Incidence of repeat SRS to the index site and a distant site. Local and distant disease recurrence at the treatment site identified by diagnostic radiologist of follow-up MRI imaging. AEs were not collected for historic controls.	0.00% 0/19 • Adverse events (AE) for the HBO Feasibility arm will be collected during the period from the initiation of the study procedures until the date of documented death, withdrawal of consent, or the end of the study, whichever occurs first. Collection could span approximately 5 years. Adverse events were not collected for the historic controls. Symptomatic treatment toxicity: AEs potentially related to intracranial SRS and/or HBO treatments Radiographic evidence for radionecrosis/treatment effects in normal tissue identified by diagnostic radiologist of follow-up MRI imaging. Incidence of WBRT, Incidence of repeat SRS to the index site and a distant site. Local and distant disease recurrence at the treatment site identified by diagnostic radiologist of follow-up MRI imaging. AEs were not collected for historic controls.
Nervous system disorders Dizziness	5.3% 1/19 • Number of events 1 • Adverse events (AE) for the HBO Feasibility arm will be collected during the period from the initiation of the study procedures until the date of documented death, withdrawal of consent, or the end of the study, whichever occurs first. Collection could span approximately 5 years. Adverse events were not collected for the historic controls. Symptomatic treatment toxicity: AEs potentially related to intracranial SRS and/or HBO treatments Radiographic evidence for radionecrosis/treatment effects in normal tissue identified by diagnostic radiologist of follow-up MRI imaging. Incidence of WBRT, Incidence of repeat SRS to the index site and a distant site. Local and distant disease recurrence at the treatment site identified by diagnostic radiologist of follow-up MRI imaging. AEs were not collected for historic controls.	5.3% 1/19 • Number of events 1 • Adverse events (AE) for the HBO Feasibility arm will be collected during the period from the initiation of the study procedures until the date of documented death, withdrawal of consent, or the end of the study, whichever occurs first. Collection could span approximately 5 years. Adverse events were not collected for the historic controls. Symptomatic treatment toxicity: AEs potentially related to intracranial SRS and/or HBO treatments Radiographic evidence for radionecrosis/treatment effects in normal tissue identified by diagnostic radiologist of follow-up MRI imaging. Incidence of WBRT, Incidence of repeat SRS to the index site and a distant site. Local and distant disease recurrence at the treatment site identified by diagnostic radiologist of follow-up MRI imaging. AEs were not collected for historic controls.
Nervous system disorders Facial muscle weakness	5.3% 1/19 • Number of events 1 • Adverse events (AE) for the HBO Feasibility arm will be collected during the period from the initiation of the study procedures until the date of documented death, withdrawal of consent, or the end of the study, whichever occurs first. Collection could span approximately 5 years. Adverse events were not collected for the historic controls. Symptomatic treatment toxicity: AEs potentially related to intracranial SRS and/or HBO treatments Radiographic evidence for radionecrosis/treatment effects in normal tissue identified by diagnostic radiologist of follow-up MRI imaging. Incidence of WBRT, Incidence of repeat SRS to the index site and a distant site. Local and distant disease recurrence at the treatment site identified by diagnostic radiologist of follow-up MRI imaging. AEs were not collected for historic controls.	5.3% 1/19 • Number of events 1 • Adverse events (AE) for the HBO Feasibility arm will be collected during the period from the initiation of the study procedures until the date of documented death, withdrawal of consent, or the end of the study, whichever occurs first. Collection could span approximately 5 years. Adverse events were not collected for the historic controls. Symptomatic treatment toxicity: AEs potentially related to intracranial SRS and/or HBO treatments Radiographic evidence for radionecrosis/treatment effects in normal tissue identified by diagnostic radiologist of follow-up MRI imaging. Incidence of WBRT, Incidence of repeat SRS to the index site and a distant site. Local and distant disease recurrence at the treatment site identified by diagnostic radiologist of follow-up MRI imaging. AEs were not collected for historic controls.
Nervous system disorders Tremor	5.3% 1/19 • Number of events 1 • Adverse events (AE) for the HBO Feasibility arm will be collected during the period from the initiation of the study procedures until the date of documented death, withdrawal of consent, or the end of the study, whichever occurs first. Collection could span approximately 5 years. Adverse events were not collected for the historic controls. Symptomatic treatment toxicity: AEs potentially related to intracranial SRS and/or HBO treatments Radiographic evidence for radionecrosis/treatment effects in normal tissue identified by diagnostic radiologist of follow-up MRI imaging. Incidence of WBRT, Incidence of repeat SRS to the index site and a distant site. Local and distant disease recurrence at the treatment site identified by diagnostic radiologist of follow-up MRI imaging. AEs were not collected for historic controls.	5.3% 1/19 • Number of events 1 • Adverse events (AE) for the HBO Feasibility arm will be collected during the period from the initiation of the study procedures until the date of documented death, withdrawal of consent, or the end of the study, whichever occurs first. Collection could span approximately 5 years. Adverse events were not collected for the historic controls. Symptomatic treatment toxicity: AEs potentially related to intracranial SRS and/or HBO treatments Radiographic evidence for radionecrosis/treatment effects in normal tissue identified by diagnostic radiologist of follow-up MRI imaging. Incidence of WBRT, Incidence of repeat SRS to the index site and a distant site. Local and distant disease recurrence at the treatment site identified by diagnostic radiologist of follow-up MRI imaging. AEs were not collected for historic controls.
Nervous system disorders Concentration impairment	0.00% 0/19 • Adverse events (AE) for the HBO Feasibility arm will be collected during the period from the initiation of the study procedures until the date of documented death, withdrawal of consent, or the end of the study, whichever occurs first. Collection could span approximately 5 years. Adverse events were not collected for the historic controls. Symptomatic treatment toxicity: AEs potentially related to intracranial SRS and/or HBO treatments Radiographic evidence for radionecrosis/treatment effects in normal tissue identified by diagnostic radiologist of follow-up MRI imaging. Incidence of WBRT, Incidence of repeat SRS to the index site and a distant site. Local and distant disease recurrence at the treatment site identified by diagnostic radiologist of follow-up MRI imaging. AEs were not collected for historic controls.	10.5% 2/19 • Number of events 2 • Adverse events (AE) for the HBO Feasibility arm will be collected during the period from the initiation of the study procedures until the date of documented death, withdrawal of consent, or the end of the study, whichever occurs first. Collection could span approximately 5 years. Adverse events were not collected for the historic controls. Symptomatic treatment toxicity: AEs potentially related to intracranial SRS and/or HBO treatments Radiographic evidence for radionecrosis/treatment effects in normal tissue identified by diagnostic radiologist of follow-up MRI imaging. Incidence of WBRT, Incidence of repeat SRS to the index site and a distant site. Local and distant disease recurrence at the treatment site identified by diagnostic radiologist of follow-up MRI imaging. AEs were not collected for historic controls.
Nervous system disorders Presyncope	0.00% 0/19 • Adverse events (AE) for the HBO Feasibility arm will be collected during the period from the initiation of the study procedures until the date of documented death, withdrawal of consent, or the end of the study, whichever occurs first. Collection could span approximately 5 years. Adverse events were not collected for the historic controls. Symptomatic treatment toxicity: AEs potentially related to intracranial SRS and/or HBO treatments Radiographic evidence for radionecrosis/treatment effects in normal tissue identified by diagnostic radiologist of follow-up MRI imaging. Incidence of WBRT, Incidence of repeat SRS to the index site and a distant site. Local and distant disease recurrence at the treatment site identified by diagnostic radiologist of follow-up MRI imaging. AEs were not collected for historic controls.	5.3% 1/19 • Number of events 1 • Adverse events (AE) for the HBO Feasibility arm will be collected during the period from the initiation of the study procedures until the date of documented death, withdrawal of consent, or the end of the study, whichever occurs first. Collection could span approximately 5 years. Adverse events were not collected for the historic controls. Symptomatic treatment toxicity: AEs potentially related to intracranial SRS and/or HBO treatments Radiographic evidence for radionecrosis/treatment effects in normal tissue identified by diagnostic radiologist of follow-up MRI imaging. Incidence of WBRT, Incidence of repeat SRS to the index site and a distant site. Local and distant disease recurrence at the treatment site identified by diagnostic radiologist of follow-up MRI imaging. AEs were not collected for historic controls.
Nervous system disorders Dysphasia	0.00% 0/19 • Adverse events (AE) for the HBO Feasibility arm will be collected during the period from the initiation of the study procedures until the date of documented death, withdrawal of consent, or the end of the study, whichever occurs first. Collection could span approximately 5 years. Adverse events were not collected for the historic controls. Symptomatic treatment toxicity: AEs potentially related to intracranial SRS and/or HBO treatments Radiographic evidence for radionecrosis/treatment effects in normal tissue identified by diagnostic radiologist of follow-up MRI imaging. Incidence of WBRT, Incidence of repeat SRS to the index site and a distant site. Local and distant disease recurrence at the treatment site identified by diagnostic radiologist of follow-up MRI imaging. AEs were not collected for historic controls.	10.5% 2/19 • Number of events 2 • Adverse events (AE) for the HBO Feasibility arm will be collected during the period from the initiation of the study procedures until the date of documented death, withdrawal of consent, or the end of the study, whichever occurs first. Collection could span approximately 5 years. Adverse events were not collected for the historic controls. Symptomatic treatment toxicity: AEs potentially related to intracranial SRS and/or HBO treatments Radiographic evidence for radionecrosis/treatment effects in normal tissue identified by diagnostic radiologist of follow-up MRI imaging. Incidence of WBRT, Incidence of repeat SRS to the index site and a distant site. Local and distant disease recurrence at the treatment site identified by diagnostic radiologist of follow-up MRI imaging. AEs were not collected for historic controls.

Additional Information

Alan Hartford, MD, PhD, FACR, Professor of Medicine (RadOnc) Director, Radiation Oncology

Dartmouth-Hitchcock Medical Center

Phone: 603-650-6600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place