cropped color_logo_with_background.png

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 85 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 1.
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.

Exclusion Criteria:

1. Active intracranial infection or nonglial brain mass. 2. Recent large intracranial hemorrhage (<1 month; size to be determined by principal investigator) 3. 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. 4. Patient lives too far from BWH and/or is unwilling/ unable to return for scheduled imaging visits. -

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01756352
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Marcelo F. Di Carli, MD, FACC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Raymond L Huang, MD
Principal Investigator Affiliation Brigham and Women's Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma Multiforme, GBM
Additional Details

The PET radiotracer FET provides a measure of large, neutral amino acid transport. This transport is significantly upregulated in malignant brain tumors. FET rarely gives false positive findings in the setting of inflammation seen after high dose chemotherapy or radiotherapy. FET labels low-grade as well as high-grade gliomas, in contrast to FDG, which almost exclusively labels only high-grade gliomas. FET imaging may prove to be particularly useful in the setting of infiltrative tumor, which is not contrast-enhancing on MRI and therefore not detectable with FDG. Management of glioblastoma patients with stable contrast-enhancing disease on MRI but increased signs of edema is difficult. This is because it is difficult to distinguish simple edema from infiltrative tumor. The former is managed with steroids and the latter is managed with chemotherapy, and anti-angiogenic drugs. FET may be particularly useful in assessing changes after GBM patients receive anti-vascular agents such as Avastin. Avastin is very commonly used in patients after failure of first-line treatment in GBM. Not only is Avastin costly, but it also can have serious side effects such as internal bleeding and gastric perforation, severe hypertension, poor wound healing, and renal toxicity. It is important to know when a patient is failing Avastin treatment so that the drug can be discontinued. Preliminary data in Europe (see figures below) suggests that FET-PET can accurately distinguish Avastin responders from non-responders. Inclusion Criteria: 1. 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. Exclusion Criteria: 1. Active intracranial infection or nonglial brain mass. 2. Recent large intracranial hemorrhage (<1 month; size to be determined by principal investigator) 3. 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. 4. Patient lives too far from BWH and/or is unwilling/ unable to return for scheduled imaging visits.

Arms & Interventions

Arms

Experimental: GBM Avastin receiving 18F-FET

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

Interventions

Drug: - 18F-FET

Radiotracer, surrogate marker for protein synthesis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Brigham and Women's Hospital, Boston, Massachusetts

Status

Address

Brigham and Women's Hospital

Boston, Massachusetts, 02115