FET-PET for Evaluation of Response of Recurrent GBM to Avastin
|ClinicalTrials.gov Identifier: NCT01756352|
Recruitment Status : Completed
First Posted : December 25, 2012
Results First Posted : October 30, 2019
Last Update Posted : October 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme GBM||Drug: 18F-FET||Phase 2|
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.
- GBM patients with changes on MRI suggestive of recurrence who have not yet initiated antiangiogenic therapy.
- Age ≥ 18
- Anticipated survival >3 months
- Able to give informed consent
- Capable of undergoing scan without the need for sedation or general anesthesia.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of the Utility of the Radiotracer "FET"in PET Imaging of Recurrent Glioblastoma Multiforme (GBM): Monitoring Early Response to Antiangiogenic Therapy|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||September 13, 2015|
|Actual Study Completion Date :||September 13, 2015|
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
Radiotracer, surrogate marker for protein synthesis
Other Name: 18F-Fluoroethyltyrosine
- Progression-free Survival [ Time Frame: 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.
- Overall Survival [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01756352
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Raymond L Huang, MD||Brigham and Women's Hospital|