Trial Outcomes & Findings for FET-PET for Evaluation of Response of Recurrent GBM to Avastin (NCT NCT01756352)

Results Overview

The primary objective is to assess the utility of FET-PET imaging for prediction of progression-free survival in recurrent glioblastoma.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

From date of baseline PET scan until the date of death from any cause, assessed up to 2 years.

Results posted on

2019-10-30

Participant milestones
Measure	GBM Avastin Receiving 18F-FET Recurrent GBM patients receiving Avastin, imaged twice with 18F-FET PET before and approximately 8 weeks after receiving Avastin 18F-FET: Radiotracer, surrogate marker for protein synthesis
Overall Study STARTED	13
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	1

Reasons for withdrawal
Measure	GBM Avastin Receiving 18F-FET Recurrent GBM patients receiving Avastin, imaged twice with 18F-FET PET before and approximately 8 weeks after receiving Avastin 18F-FET: Radiotracer, surrogate marker for protein synthesis
Overall Study moved away and lost to followup	1

FET-PET for Evaluation of Response of Recurrent GBM to Avastin

Baseline characteristics by cohort
Measure	GBM Avastin Receiving 18F-FET n=12 Participants Recurrent GBM patients receiving Avastin, imaged twice with 18F-FET PET before and approximately 8 weeks after receiving Avastin 18F-FET: Radiotracer, surrogate marker for protein synthesis
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	61.4 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

Timeframe: From date of baseline PET scan until the date of death from any cause, assessed up to 2 years.

The primary objective is to assess the utility of FET-PET imaging for prediction of progression-free survival in recurrent glioblastoma.

Outcome measures
Measure	GBM Avastin Receiving 18F-FET n=12 Participants Recurrent GBM patients receiving Avastin, imaged twice with 18F-FET PET before and approximately 8 weeks after receiving Avastin 18F-FET: Radiotracer, surrogate marker for protein synthesis
Progression-free Survival	158.25 days Standard Deviation 161.7

Timeframe: From date of baseline PET scan until the date of death from any cause, assessed up to 2 years.

The secondary objective is to assess the utility of FET-PET imaging for prediction of overall survival in recurrent glioblastoma.

Outcome measures
Measure	GBM Avastin Receiving 18F-FET n=12 Participants Recurrent GBM patients receiving Avastin, imaged twice with 18F-FET PET before and approximately 8 weeks after receiving Avastin 18F-FET: Radiotracer, surrogate marker for protein synthesis
Overall Survival	270.58 days Standard Deviation 222.00

Serious events: 0 serious events

Other events: 2 other events

Deaths: 12 deaths

Adverse event data not reported

Other adverse events
Measure	GBM Avastin Receiving 18F-FET n=12 participants at risk Recurrent GBM patients receiving Avastin, imaged twice with 18F-FET PET before and approximately 8 weeks after receiving Avastin 18F-FET: Radiotracer, surrogate marker for protein synthesis
Vascular disorders Bruising	16.7% 2/12 • From date of baseline PET scan until the date of death from any cause, assessed up to 2 years.

Brigham and Women's Hospital

Phone: (617) 732-6290