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

NCT01756352 | Completed Phase 2 Results

• 1 other identifier: 2012P002678
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis: The central hypothesis underlying the proposed research study is that FET-PET will predict durable benefit in patients receiving anti-angiogenic benefit for presumed recurrent GBM (i.e. progression-free survival and overall survival). We have defined one primary specific aim, for which we expect to obtain definitive results, and two secondary aims, under which we plan to generate preliminary data to support a future, larger project.

Conditions

Glioblastoma Multiforme; GBM

Keywords

FET; Fluoroethyl tyrosine; GBM; Response to treatment; Avastin; Brain Tumor

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

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

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

Secondary Outcomes (1)

• Overall Survival

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

Study Arms (1)

GBM Avastin receiving 18F-FET

EXPERIMENTAL

Recurrent GBM patients receiving Avastin, imaged twice with 18F-FET PET before and approximately 8 weeks after receiving Avastin

Drug: 18F-FET

Interventions

18F-FET DRUG

Radiotracer, surrogate marker for protein synthesis

Also known as: 18F-Fluoroethyltyrosine

GBM Avastin receiving 18F-FET

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. GBM patients with changes on MRI suggestive of recurrence who have not yet initiated antiangiogenic therapy. 2. Age ≥ 18 3. Anticipated survival \>3 months 4. Able to give informed consent 5. Capable of undergoing scan without the need for sedation or general anesthesia.

You may not qualify if:

• Active intracranial infection or nonglial brain mass.
• Recent large intracranial hemorrhage (\<1 month; size to be determined by principal investigator)
• Pregnant or nursing. Quantitative serum hCG testing will be performed prior to the initial and each -subsequent FET- PET scan on all females of childbearing potential. Our BWH Radiation Safety Committee and Partners IRB requires stat serum ß-hcG pregnancy tests.
• Patient lives too far from BWH and/or is unwilling/ unable to return for scheduled imaging visits.

Sponsors & Collaborators

• Marcelo F. Di Carli, MD, FACC: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms

Interventions

(18F)fluoroethyltyrosine

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Marcelo DiCarli, MD
• Organization: Brigham and Women's Hospital

mdicarli@bwh.harvard.edu

(617) 732-6290

Study Officials

• Raymond L Huang, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Nuclear Medicine/PET

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: December 25, 2012
• Study Start: February 1, 2013
• Primary Completion: September 13, 2015
• Study Completion: September 13, 2015
• Last Updated: October 30, 2019
• Results First Posted: October 30, 2019

Record last verified: 2019-10

Locations

US (1)