Trial Outcomes & Findings for Image-Based Quantitative Assessment of Acute Radiation-Induced Changes in Glioma (NCT NCT03168919)

NCT ID: NCT03168919

Last Updated: 2019-10-01

Results Overview

Multiple MRI techniques will be used to assess chemical environment (Cho/NAA) of the tumor during the course of fractionated radiation treatment.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 5 participants
• Primary outcome timeframe: From Baseline to 6 weeks.
• Results posted on: 2019-10-01

Participant Flow

Recruitment period: 10/2016 through 3/2018 Location: The subjects were identified from the hospital during the admission for resection of the tumor. They were recruited from the clinic of the radiation oncologists and/or neurosurgeons.

Subject #2: Voluntary withdrawal. Subject #5: Voluntary withdrawal.

Participant milestones

Measure	Chemoradiation With MRI Assessment This study has only one arm. The eligible subjects will receive standard of care fractionated radiation therapy along with concomitant temozolomide, which will NOT be changed based on the MRI scans obtained as a part of this study. There is no control or sham group. Fractionated Radiation: Standard of care fractionated radiation therapy will be given to the tumor. Temozolomide: Standard of care temozolomide will be given along with radiation therapy MRI: Four MRI scan will be performed according to the protocol. The first one will be obtained before start of radiation therapy, the second MRI will be obtained after completion of 20 +/- 4 Gy, the third MRI will be obtained after completion of 40 +/- 4 Gy, and the final MRI will be obtained after completion of the radiation therapy.
Overall Study STARTED	5
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure

Chemoradiation With MRI Assessment This study has only one arm. The eligible subjects will receive standard of care fractionated radiation therapy along with concomitant temozolomide, which will NOT be changed based on the MRI scans obtained as a part of this study. There is no control or sham group. Fractionated Radiation: Standard of care fractionated radiation therapy will be given to the tumor. Temozolomide: Standard of care temozolomide will be given along with radiation therapy MRI: Four MRI scan will be performed according to the protocol. The first one will be obtained before start of radiation therapy, the second MRI will be obtained after completion of 20 +/- 4 Gy, the third MRI will be obtained after completion of 40 +/- 4 Gy, and the final MRI will be obtained after completion of the radiation therapy.

Overall Study Withdrawal by Subject

2

Baseline Characteristics

Image-Based Quantitative Assessment of Acute Radiation-Induced Changes in Glioma

Baseline characteristics by cohort

Measure	Chemoradiation With MRI Assessment n=5 Participants This study has only one arm. The eligible subjects will receive standard of care fractionated radiation therapy along with concomitant temozolomide, which will NOT be changed based on the MRI scans obtained as a part of this study. There is no control or sham group. Fractionated Radiation: Standard of care fractionated radiation therapy will be given to the tumor. Temozolomide: Standard of care temozolomide will be given along with radiation therapy MRI: Four MRI scan will be performed according to the protocol. The first one will be obtained before start of radiation therapy, the second MRI will be obtained after completion of 20 +/- 4 Gy, the third MRI will be obtained after completion of 40 +/- 4 Gy, and the final MRI will be obtained after completion of the radiation therapy.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	62.8 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants
Glioblastoma Diagnosis	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline to 6 weeks.

Population: The number of participants dropped from 5 to 3 because 2 participants withdrew from the study. The chemical evaluation could not be evaluated due to poor quality imaging.

Multiple MRI techniques will be used to assess chemical environment (Cho/NAA) of the tumor during the course of fractionated radiation treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline to 6 weeks

Population: Only 3 subjects completed the treatment.

Diffusion MRI will be used for assessment of measures tumor cellularity (with minimum apparent diffusion co-efficent, ADC) during the course of fractionated radiation treatment.

Outcome measures

Measure	Chemoradiation With MRI Assessment n=3 Participants This study has only one arm. The eligible subjects will receive standard of care fractionated radiation therapy along with concomitant temozolomide, which will NOT be changed based on the MRI scans obtained as a part of this study. There is no control or sham group. Fractionated Radiation: Standard of care fractionated radiation therapy will be given to the tumor. Temozolomide: Standard of care temozolomide will be given along with radiation therapy MRI: Four MRI scan will be performed according to the protocol. The first one will be obtained before start of radiation therapy, the second MRI will be obtained after completion of 20 +/- 4 Gy, the third MRI will be obtained after completion of 40 +/- 4 Gy, and the final MRI will be obtained after completion of the radiation therapy.
Changes of Tumor Cellularity Baseline	0.000675 mm^2/sec Interval 0.00058 to 0.000821
Changes of Tumor Cellularity Early in therapy (At 2 weeks in therapy)	0.000798 mm^2/sec Interval 0.000642 to 0.000984
Changes of Tumor Cellularity Late therapy (At 4 weeks in therapy)	0.000842 mm^2/sec Interval 0.000675 to 0.0013
Changes of Tumor Cellularity At completion (At 6 weeks from baseline)	0.001144 mm^2/sec Interval 0.000753 to 0.0018

SECONDARY outcome

Timeframe: From baseline Up to 6 weeks

Population: Measurements performed only in 2 subjects .

MRI will be used for assessment of measures tumor volume.

Outcome measures

Measure	Chemoradiation With MRI Assessment n=2 Participants This study has only one arm. The eligible subjects will receive standard of care fractionated radiation therapy along with concomitant temozolomide, which will NOT be changed based on the MRI scans obtained as a part of this study. There is no control or sham group. Fractionated Radiation: Standard of care fractionated radiation therapy will be given to the tumor. Temozolomide: Standard of care temozolomide will be given along with radiation therapy MRI: Four MRI scan will be performed according to the protocol. The first one will be obtained before start of radiation therapy, the second MRI will be obtained after completion of 20 +/- 4 Gy, the third MRI will be obtained after completion of 40 +/- 4 Gy, and the final MRI will be obtained after completion of the radiation therapy.
Changes of Tumor Volume Baseline	6.1 cm3 Interval 4.6 to 8.0
Changes of Tumor Volume Early in therapy (At 2 weeks in therapy)	3.79 cm3 Interval 1.5 to 6.5
Changes of Tumor Volume Late therapy (At 4 weeks in therapy)	2.66 cm3 Interval 0.49 to 4.6
Changes of Tumor Volume At completion (At 6 weeks from baseline)	2.16 cm3 Interval 0.52 to 3.8

SECONDARY outcome

Timeframe: From baseline to 6 weeks

Population: Results of only 2 subjects was included.

Perfusion MRI will be used for assessment of tumor angiogenesis (with median normalized cerbral blood volume, nCBV) during the course of fractionated radiation treatment.

Outcome measures

Measure	Chemoradiation With MRI Assessment n=2 Participants This study has only one arm. The eligible subjects will receive standard of care fractionated radiation therapy along with concomitant temozolomide, which will NOT be changed based on the MRI scans obtained as a part of this study. There is no control or sham group. Fractionated Radiation: Standard of care fractionated radiation therapy will be given to the tumor. Temozolomide: Standard of care temozolomide will be given along with radiation therapy MRI: Four MRI scan will be performed according to the protocol. The first one will be obtained before start of radiation therapy, the second MRI will be obtained after completion of 20 +/- 4 Gy, the third MRI will be obtained after completion of 40 +/- 4 Gy, and the final MRI will be obtained after completion of the radiation therapy.
Changes of Tumor Angiogenesis baseline	3.78 mL/100 gm of brain tissue Interval 0.9 to 5.34
Changes of Tumor Angiogenesis Early in therapy (At 2 weeks in therapy)	3.35 mL/100 gm of brain tissue Interval 1.3 to 5.4
Changes of Tumor Angiogenesis Late therapy (At 4 weeks in therapy)	1.58 mL/100 gm of brain tissue Interval 1.05 to 2.3
Changes of Tumor Angiogenesis At completion (At 6 weeks from baseline)	1.2 mL/100 gm of brain tissue Interval 0.21 to 2.2

OTHER_PRE_SPECIFIED outcome

Timeframe: From Baseline through 24 months.

Percentage change of the Cho/NAA, ADC and nCBV from baseline to the end of radiation therapy, RT will be used for assessment of time to progression.

Outcome measures

Measure

Chemoradiation With MRI Assessment n=3 Participants This study has only one arm. The eligible subjects will receive standard of care fractionated radiation therapy along with concomitant temozolomide, which will NOT be changed based on the MRI scans obtained as a part of this study. There is no control or sham group. Fractionated Radiation: Standard of care fractionated radiation therapy will be given to the tumor. Temozolomide: Standard of care temozolomide will be given along with radiation therapy MRI: Four MRI scan will be performed according to the protocol. The first one will be obtained before start of radiation therapy, the second MRI will be obtained after completion of 20 +/- 4 Gy, the third MRI will be obtained after completion of 40 +/- 4 Gy, and the final MRI will be obtained after completion of the radiation therapy.

Time to Progression

465 days Interval 252.0 to 820.0

Adverse Events

Chemoradiation With MRI Assessment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Asim K. Bag, MD Bag

St. Jude Children's Reaserch Hospital

Phone: 9015953347

Email: asim.bag@stjude.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place