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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Brigham and Women's Hospital
Sponsor:
Information provided by (Responsible Party):
Laura L. Horky, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01756352
First received: December 20, 2012
Last updated: December 13, 2013
Last verified: December 2013
  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.


Condition Intervention Phase
Glioblastoma Multiforme
GBM
Drug: 18F-FET
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Assessment of the Utility of the Radiotracer "FET"in PET Imaging of Recurrent Glioblastoma Multiforme (GBM): Monitoring Early Response to Antiangiogenic Therapy

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Change in FET uptake between baseline and follow-upm, relative to survival and progression on MRI [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    We will look for indicators of radiographic response on FET-PET using changes in SUV. These outcomes will be correlated with progression-free survival and overall survival.


Estimated Enrollment: 30
Study Start Date: February 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: 18F-FET
Radiotracer, surrogate marker for protein synthesis
Other Name: 18F-Fluoroethyltyrosine

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

    -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01756352

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Laura Horky, MD, PhD    617-732-8667    lhorky@partners.org   
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Laura L Horky, MD, PhD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Laura L. Horky, Instructor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01756352     History of Changes
Other Study ID Numbers: 2012P00 Pending
Study First Received: December 20, 2012
Last Updated: December 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:
FET
Fluoroethyl tyrosine
GBM
Response to treatment
Avastin
Brain Tumor

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014