Trial Outcomes & Findings for 18F-DOPA-PET/MRI Scan in Imaging Elderly Patients With Newly Diagnosed Grade IV Malignant Glioma or Glioblastoma During Planning for a Short Course of Proton Beam Radiation Therapy (NCT NCT03778294)

Last Updated: 2025-07-03

Results Overview

The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated utilizing exact binomial methodology. The distribution of survival time will be estimated using the method of Kaplan-Meier (1958).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

Time from registration to death due to any cause, assessed up to 12 months

Results posted on

2025-07-03

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (18F-DOPA, PET/MRI, PET/CT, Temozolomide) Patients receive 18F-DOPA IV and undergo PET/MRI or PET/CT imaging scan. Patients then receive proton beam radiotherapy over 5 or 10 consecutive days excluding weekend and standard of care temozolomide on days 1-7 or 1-14. Beginning cycles 2, patients receive standard of care temozolomide on days 1-5. Cycles with temozolomide repeat every 28 days for up to 7 cycles in the in the absence of disease progression or unacceptable toxicity.\> \> Computed Tomography: Undergo PET/CT\> \> Fluorodopa F 18: Given IV\> \> Magnetic Resonance Imaging: Undergo PET/MRI\> \> Positron Emission Tomography: Undergo PET/CT or PET/MRI\> \> Proton Beam Radiation Therapy: Receive proton beam RT\> \> Quality-of-Life Assessment: Ancillary studies\> \> Questionnaire Administration: Ancillary studies\> \> Temozolomide: Drug
Overall Study STARTED	43
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (18F-DOPA, PET/MRI, PET/CT, Temozolomide) Patients receive 18F-DOPA IV and undergo PET/MRI or PET/CT imaging scan. Patients then receive proton beam radiotherapy over 5 or 10 consecutive days excluding weekend and standard of care temozolomide on days 1-7 or 1-14. Beginning cycles 2, patients receive standard of care temozolomide on days 1-5. Cycles with temozolomide repeat every 28 days for up to 7 cycles in the in the absence of disease progression or unacceptable toxicity.\> \> Computed Tomography: Undergo PET/CT\> \> Fluorodopa F 18: Given IV\> \> Magnetic Resonance Imaging: Undergo PET/MRI\> \> Positron Emission Tomography: Undergo PET/CT or PET/MRI\> \> Proton Beam Radiation Therapy: Receive proton beam RT\> \> Quality-of-Life Assessment: Ancillary studies\> \> Questionnaire Administration: Ancillary studies\> \> Temozolomide: Drug
Overall Study Death	1
Overall Study Issues with insurance	1
Overall Study disease progression before treatment	2

Baseline Characteristics

18F-DOPA-PET/MRI Scan in Imaging Elderly Patients With Newly Diagnosed Grade IV Malignant Glioma or Glioblastoma During Planning for a Short Course of Proton Beam Radiation Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (18F-DOPA, PET/MRI, PET/CT, Temozolomide) n=39 Participants Patients receive 18F-DOPA IV and undergo PET/MRI or PET/CT imaging scan. Patients then receive proton beam radiotherapy over 5 or 10 consecutive days excluding weekend and standard of care temozolomide on days 1-7 or 1-14. Beginning cycles 2, patients receive standard of care temozolomide on days 1-5. Cycles with temozolomide repeat every 28 days for up to 7 cycles in the in the absence of disease progression or unacceptable toxicity.\> \> Computed Tomography: Undergo PET/CT\> \> Fluorodopa F 18: Given IV\> \> Magnetic Resonance Imaging: Undergo PET/MRI\> \> Positron Emission Tomography: Undergo PET/CT or PET/MRI\> \> Proton Beam Radiation Therapy: Receive proton beam RT\> \> Quality-of-Life Assessment: Ancillary studies\> \> Questionnaire Administration: Ancillary studies\> \> Temozolomide: Drug
Age, Continuous	71.617 years STANDARD_DEVIATION 5.097 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Corticosteroid therapy at study entry? Yes	21 Participants n=5 Participants
Corticosteroid therapy at study entry? No	18 Participants n=5 Participants
Path result/Molecular factors IDH1 mutant	0 Participants n=5 Participants
Path result/Molecular factors IDH1 Wildtype	39 Participants n=5 Participants
ECOG Performance Status 0	13 Participants n=5 Participants
ECOG Performance Status 1	19 Participants n=5 Participants
ECOG Performance Status 2	7 Participants n=5 Participants
Neurological Deficit Yes	13 Participants n=5 Participants
Neurological Deficit No	26 Participants n=5 Participants
History of seizure Yes	10 Participants n=5 Participants
History of seizure No	29 Participants n=5 Participants
Extent of surgery Gross total resection	16 Participants n=5 Participants
Extent of surgery Subtotal resection	8 Participants n=5 Participants
Extent of surgery Biopsy	15 Participants n=5 Participants
MGMT Methylated	13 Participants n=5 Participants
MGMT Unmethylated	24 Participants n=5 Participants
MGMT Not available	2 Participants n=5 Participants
Family history of brain tumor Yes	1 Participants n=5 Participants
Family history of brain tumor No	38 Participants n=5 Participants
Use of alternating electrical therapy Yes	0 Participants n=5 Participants
Use of alternating electrical therapy No	39 Participants n=5 Participants

PRIMARY outcome

Timeframe: Time from registration to death due to any cause, assessed up to 12 months

Outcome measures

Outcome measures
Measure	Treatment (18F-DOPA, PET/MRI, PET/CT, Temozolomide) n=39 Participants Patients receive 18F-DOPA IV and undergo PET/MRI or PET/CT imaging scan. Patients then receive proton beam radiotherapy over 5 or 10 consecutive days excluding weekend and standard of care temozolomide on days 1-7 or 1-14. Beginning cycles 2, patients receive standard of care temozolomide on days 1-5. Cycles with temozolomide repeat every 28 days for up to 7 cycles in the in the absence of disease progression or unacceptable toxicity. \> \> Computed Tomography: Undergo PET/CT \> \> Fluorodopa F 18: Given IV \> \> Magnetic Resonance Imaging: Undergo PET/MRI \> \> Positron Emission Tomography: Undergo PET/CT or PET/MRI \> \> Proton Beam Radiation Therapy: Receive proton beam RT \> \> Quality-of-Life Assessment: Ancillary studies \> \> Questionnaire Administration: Ancillary studies \> \> Temozolomide: Drug
Overall Survival (OS)	0.54 proportion of successes Interval 0.43 to 1.0

SECONDARY outcome

Timeframe: At 12 months after radiation therapy

Defined as the time from registration to the earliest date documenting disease progression

Outcome measures

Outcome measures
Measure	Treatment (18F-DOPA, PET/MRI, PET/CT, Temozolomide) n=39 Participants Patients receive 18F-DOPA IV and undergo PET/MRI or PET/CT imaging scan. Patients then receive proton beam radiotherapy over 5 or 10 consecutive days excluding weekend and standard of care temozolomide on days 1-7 or 1-14. Beginning cycles 2, patients receive standard of care temozolomide on days 1-5. Cycles with temozolomide repeat every 28 days for up to 7 cycles in the in the absence of disease progression or unacceptable toxicity. \> \> Computed Tomography: Undergo PET/CT \> \> Fluorodopa F 18: Given IV \> \> Magnetic Resonance Imaging: Undergo PET/MRI \> \> Positron Emission Tomography: Undergo PET/CT or PET/MRI \> \> Proton Beam Radiation Therapy: Receive proton beam RT \> \> Quality-of-Life Assessment: Ancillary studies \> \> Questionnaire Administration: Ancillary studies \> \> Temozolomide: Drug
Progression Free Survival	0.72 proportion of successes Interval 0.55 to 0.85

SECONDARY outcome

Timeframe: Up to 4 years

Defined as the time from registration to the earliest date documenting disease progression

Outcome measures

Outcome measures
Measure	Treatment (18F-DOPA, PET/MRI, PET/CT, Temozolomide) n=39 Participants Patients receive 18F-DOPA IV and undergo PET/MRI or PET/CT imaging scan. Patients then receive proton beam radiotherapy over 5 or 10 consecutive days excluding weekend and standard of care temozolomide on days 1-7 or 1-14. Beginning cycles 2, patients receive standard of care temozolomide on days 1-5. Cycles with temozolomide repeat every 28 days for up to 7 cycles in the in the absence of disease progression or unacceptable toxicity. \> \> Computed Tomography: Undergo PET/CT \> \> Fluorodopa F 18: Given IV \> \> Magnetic Resonance Imaging: Undergo PET/MRI \> \> Positron Emission Tomography: Undergo PET/CT or PET/MRI \> \> Proton Beam Radiation Therapy: Receive proton beam RT \> \> Quality-of-Life Assessment: Ancillary studies \> \> Questionnaire Administration: Ancillary studies \> \> Temozolomide: Drug
Progression Free Survival	6.9 months Interval 6.01 to 9.66

SECONDARY outcome

Timeframe: Up to 4 years

The rate of acute and late treatment-related toxicities for newly diagnosed high-grade glioma patients treated with fluorodopa F 18-positron emission tomography (18F-DOPA PET) image-guided hypofractionated proton beam therapy will be determined, with acute radiotherapy (RT) toxicities graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Outcome measures

Outcome measures
Measure	Treatment (18F-DOPA, PET/MRI, PET/CT, Temozolomide) n=39 Participants Patients receive 18F-DOPA IV and undergo PET/MRI or PET/CT imaging scan. Patients then receive proton beam radiotherapy over 5 or 10 consecutive days excluding weekend and standard of care temozolomide on days 1-7 or 1-14. Beginning cycles 2, patients receive standard of care temozolomide on days 1-5. Cycles with temozolomide repeat every 28 days for up to 7 cycles in the in the absence of disease progression or unacceptable toxicity. \> \> Computed Tomography: Undergo PET/CT \> \> Fluorodopa F 18: Given IV \> \> Magnetic Resonance Imaging: Undergo PET/MRI \> \> Positron Emission Tomography: Undergo PET/CT or PET/MRI \> \> Proton Beam Radiation Therapy: Receive proton beam RT \> \> Quality-of-Life Assessment: Ancillary studies \> \> Questionnaire Administration: Ancillary studies \> \> Temozolomide: Drug
Incidence of Adverse Events (AEs) Grade 3 Acute	7 Participants
Incidence of Adverse Events (AEs) Grade 2 Post Baseline	34 Participants
Incidence of Adverse Events (AEs) Grade 3 Post Baseline	18 Participants
Incidence of Adverse Events (AEs) Grade 4 Post Baseline	5 Participants
Incidence of Adverse Events (AEs) Grade 2 Acute	27 Participants
Incidence of Adverse Events (AEs) Grade 4 Acute	0 Participants
Incidence of Adverse Events (AEs) Grade 2 Late	24 Participants
Incidence of Adverse Events (AEs) Grade 3 Late	14 Participants
Incidence of Adverse Events (AEs) Grade 4 Late	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years post treatment

Paired t-test statistical analysis will be performed to determine if any differences exist and the level of statistical significance between treatment volumes defined by magnetic resonance (MR) only and treatment volumes defined with both positron emission tomography (PET) and MR information.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years post treatment

QOL surveys will be compared to data from historical controls. Quality of life will be assessed at baseline and at each magnetic resonance imaging (MRI) evaluation (up to 6 evaluations). QOL will be measured using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30, a 30-item patient-reported questionnaire about patient ability to function, symptoms related to the cancer and its treatment, overall health and quality of life, and perceived financial impact of the cancer and its treatment. 28 of the 30 items are measured on a 1-4 scale (1=not at all; 4=very much) with the remaining two items (overall health and overall quality of life) scored on a 1-7 numeric analogue scale (1=very poor; 7=excellent). The recall period for the EORTC QLQ-C30 is one week. Higher scores indicate better QoL for overall health status and functioning scales, and worse QoL for symptom scales

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years post treatment

Paired t-test statistical analysis will be performed to determine if any differences exist and the level of statistical significance between proton plan metrics based off two modeling/evaluation techniques: radiobiologic modeling/evaluation techniques performed at Mayo Clinic Rochester and Linear Energy Transfer (LET) distribution evaluation at Mayo Clinic Arizona

Outcome measures

Outcome data not reported

Adverse Events

Treatment (18F-DOPA, PET/MRI, PET/CT, Temozolomide)

Serious events: 0 serious events

Other events: 39 other events

Deaths: 32 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (18F-DOPA, PET/MRI, PET/CT, Temozolomide) n=39 participants at risk Temozolomide: Drug
Endocrine disorders Adrenal insufficiency	2.6% 1/39 • Number of events 1 • Up to 4 years
Eye disorders Blurred vision	10.3% 4/39 • Number of events 4 • Up to 4 years
Gastrointestinal disorders Abdominal pain	2.6% 1/39 • Number of events 1 • Up to 4 years
General disorders Fatigue	92.3% 36/39 • Number of events 135 • Up to 4 years
General disorders Pain	5.1% 2/39 • Number of events 2 • Up to 4 years
Injury, poisoning and procedural complications Bruising	2.6% 1/39 • Number of events 2 • Up to 4 years
Investigations Lymphocyte count decreased	28.2% 11/39 • Number of events 18 • Up to 4 years
Investigations Platelet count decreased	23.1% 9/39 • Number of events 10 • Up to 4 years
Investigations Weight loss	20.5% 8/39 • Number of events 16 • Up to 4 years
Metabolism and nutrition disorders Anorexia	20.5% 8/39 • Number of events 11 • Up to 4 years
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	2.6% 1/39 • Number of events 1 • Up to 4 years
Nervous system disorders Amnesia	2.6% 1/39 • Number of events 1 • Up to 4 years
Nervous system disorders Ataxia	2.6% 1/39 • Number of events 1 • Up to 4 years
Nervous system disorders Central nervous system necrosis	61.5% 24/39 • Number of events 48 • Up to 4 years
Nervous system disorders Concentration impairment	2.6% 1/39 • Number of events 1 • Up to 4 years
Nervous system disorders Dysphasia	10.3% 4/39 • Number of events 4 • Up to 4 years
Nervous system disorders Encephalopathy	28.2% 11/39 • Number of events 14 • Up to 4 years
Nervous system disorders Headache	53.8% 21/39 • Number of events 40 • Up to 4 years
Nervous system disorders Memory impairment	7.7% 3/39 • Number of events 3 • Up to 4 years
Nervous system disorders Muscle weakness left-sided	5.1% 2/39 • Number of events 7 • Up to 4 years
Nervous system disorders Muscle weakness right-sided	2.6% 1/39 • Number of events 1 • Up to 4 years
Nervous system disorders Seizure	41.0% 16/39 • Number of events 21 • Up to 4 years
Psychiatric disorders Agitation	2.6% 1/39 • Number of events 1 • Up to 4 years
Psychiatric disorders Confusion	51.3% 20/39 • Number of events 41 • Up to 4 years
Psychiatric disorders Irritability	2.6% 1/39 • Number of events 1 • Up to 4 years
Respiratory, thoracic and mediastinal disorders Dyspnea	2.6% 1/39 • Number of events 1 • Up to 4 years
Skin and subcutaneous tissue disorders Alopecia	74.4% 29/39 • Number of events 71 • Up to 4 years
Vascular disorders Hypertension	2.6% 1/39 • Number of events 1 • Up to 4 years

Additional Information

Dr Sujay Vora

Mayo Clinic

Phone: 480-342-1262

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place