Clinical Trial · NCT01867593

MET-PET for Newly Diagnosed Glioblastoma

Overview

This research study is a prospective pilot study. The purpose of a pilot clinical study is to obtain preliminary data to support the reason for doing a larger clinical trial on testing the clinical effectiveness of an investigational intervention. "Investigational" means that the role of MET-PET scans is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved this intervention for your type cancer. In this research study, the investigators are evaluating whether or not MET-PET scans have value in predicting response to standard chemoradiation therapy in participants with newly-diagnosed glioblastoma. A standard treatment for glioblastoma is treatment with a combination of radiation therapy and chemotherapy with the drug temozolomide. In PET scans, a radioactive substance is injected into the body. The scanning machine finds the radioactive substance, which tends to go to cancer cells. With standard PET scans, the radioactive substance used is FDG. FDG goes to many areas of the normal brain which makes it difficult for use in distinguishing brain tumors from normal tissue. For the PET scans in this research study, the investigators are using a radioactive substance called MET, instead of the standard substance FDG. MET gets absorbed by cancer cells but not by normal brain and therefore may be better than FDG in evaluating brain tumors and therefore may be better than FDG in evaluating brain tumors and their response to treatment. In this research study, participants will receive standard chemotherapy and radiation therapy for glioblastoma as well as standard MRI scans. In addition, participants will undergo L-\[Methyl\]-11C Methionine Positron Emission Tomography (MET-PET) scans twice. The first MET-PET scan will occur after enrollment but prior to radiation therapy. The second MET-PET scan will occur approximately one month after completion of radiation therapy.

Sponsor

Massachusetts General Hospital

Phase

Early Phase 1

Contacts

Kevin Oh, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01867593

Drug / Compound

Methionine

Isotope(s):

Target(s):

Amino Acid Transport

Ligand Class: Small Molecules

Eligibility

Inclusion

Histologically or cytologically confirmed newly-diagnosed glioblastoma or gliosarcoma and planning to undergo standard chemoradiation treatment
Life expectancy of at least 12 weeks

Exclusion

Receiving any other study agent
Prior invasive malignancy (except non-melanomatous skin cancer or disease free for at least 3 years)
HIV positive on antiretroviral therapy
Have received any treatment regimen including a VEGF-R inhibitor such as bevacizumab or cediranib or plant to receive such agents
Not recovered from adverse events due to previous treatment
Pregnant or breastfeeding
Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas)
History of allergic reactions attributed to compounds of similar chemical or biologic composition to L-\[methyl\]-C methionine
Prior use of radiosensitizers, Gliadel wafers or other interstitial intracranial treatments
Uncontrolled intercurrent illness
Glioblastoma involving the brainstem or posterior fossa, cerebrospinal fluid dissemination
Prior history of radiation therapy that would lead to overlap wtih new radiation fields
Inability to undergo MRI with gadolinium contrast or PET imaging