Trial Outcomes & Findings for Bevacizumab w / Temozolomide PET & Vascular MRI For GBM (NCT NCT01987830)

Results Overview

Number of patients with a decrease in median tumor standard uptake value (SUV). Median tumor SUV was used as a marker of temozolomide uptake.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

13 participants

Primary outcome timeframe

Day 15

Results posted on

2020-09-04

Participant milestones
Measure	TMZ-PET Scans/ MRI-PET Scan Patients taking daily temozolomide 50 mg/m2/day will undergo a PET scan using radiolabeled temozolomide (TMZ-PET) at 3 time points: 7-13 days after initiation of temozolomide but before beginning bevacizumab ("baseline"- temozolomide steady-state scan), 1 day after initiation of bevacizumab (day 15) and 1 month after initiation of bevacizumab (day 45). Arterialized venous blood samples were collected during the imaging in order to measure radioactivity, blood metabolites, and the relationship between radiotracer uptake and tumor features such as blood-brain barrier (BBB) breakdown and tumor blood flow.
Overall Study STARTED	13
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	1

Reasons for withdrawal
Measure	TMZ-PET Scans/ MRI-PET Scan Patients taking daily temozolomide 50 mg/m2/day will undergo a PET scan using radiolabeled temozolomide (TMZ-PET) at 3 time points: 7-13 days after initiation of temozolomide but before beginning bevacizumab ("baseline"- temozolomide steady-state scan), 1 day after initiation of bevacizumab (day 15) and 1 month after initiation of bevacizumab (day 45). Arterialized venous blood samples were collected during the imaging in order to measure radioactivity, blood metabolites, and the relationship between radiotracer uptake and tumor features such as blood-brain barrier (BBB) breakdown and tumor blood flow.
Overall Study Never received baseline scan	1

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	TMZ-PET Scans/ MRI-PET Scan n=13 Participants The investigators plan to study patients with recurrent glioblastoma whose clinical care plan includes treatment with bevacizumab and temozolomide. Patients taking daily temozolomide 50 mg/m2/day will undergo a PET scan using radiolabeled temozolomide (TMZ-PET) at 3 time points: 7-13 days after initiation of temozolomide but before beginning bevacizumab ("baseline"- temozolomide steady-state scan), 1 day after initiation of bevacizumab (day 15) and 1 month after initiation of bevacizumab (day 45). Arterialized venous blood samples will be collected during the imaging in order to measure radioactivity, blood metabolites, and the relationship between radiotracer uptake and tumor features such as blood-brain barrier (BBB) breakdown and tumor blood flow. In addition, we will explore the link between flow, permeability, and tumor temozolomide retention. These studies will be performed using our human simultaneous MRI-PET imaging camera. MRI-PET: - \[11C\] temozolomide for PET scan and
Age, Continuous	62 years n=13 Participants
Sex: Female, Male Female	9 Participants n=13 Participants
Sex: Female, Male Male	4 Participants n=13 Participants
Region of Enrollment United States	13 Participants n=13 Participants

Timeframe: Day 15

Population: Tumor SUV measurements were only available for 8 patients

Number of patients with a decrease in median tumor standard uptake value (SUV). Median tumor SUV was used as a marker of temozolomide uptake.

Outcome measures
Measure	TMZ-PET Scans/ MRI-PET Scan n=8 Participants Patients taking daily temozolomide 50 mg/m2/day will undergo a PET scan using radiolabeled temozolomide (TMZ-PET) at 3 time points: 7-13 days after initiation of temozolomide but before beginning bevacizumab ("baseline"- temozolomide steady-state scan), 1 day after initiation of bevacizumab (day 15) and 1 month after initiation of bevacizumab (day 45). Arterialized venous blood samples were collected during the imaging in order to measure radioactivity, blood metabolites, and the relationship between radiotracer uptake and tumor features such as blood-brain barrier (BBB) breakdown and tumor blood flow.
Number of Patients With a Decrease in Median Tumor SUV	6 Participants

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	TMZ-PET Scans/ MRI-PET Scan n=12 participants at risk Patients taking daily temozolomide 50 mg/m2/day will undergo a PET scan using radiolabeled temozolomide (TMZ-PET) at 3 time points: 7-13 days after initiation of temozolomide but before beginning bevacizumab ("baseline"- temozolomide steady-state scan), 1 day after initiation of bevacizumab (day 15) and 1 month after initiation of bevacizumab (day 45). Arterialized venous blood samples were collected during the imaging in order to measure radioactivity, blood metabolites, and the relationship between radiotracer uptake and tumor features such as blood-brain barrier (BBB) breakdown and tumor blood flow.
Injury, poisoning and procedural complications Wound Dehiscence	8.3% 1/12 • Number of events 1 • Up to day 42
Vascular disorders Thromboembolic event	8.3% 1/12 • Number of events 1 • Up to day 42

Adverse event data not reported

Massachusetts General Hospital

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