MET-PET for Newly Diagnosed Glioblastoma

NCT01867593 | Completed Early Phase 1 DMC

• 1 other identifier: 13-018
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioblastoma

Keywords

Newly diagnosed

Outcome Measures

Primary Outcomes (1)

• Effect of C-11 methionine PET on progression free survival

  PET uptake at 1 month after chemoRT (lesion/normal ratio) correlated with progression free survival

  2 years

Secondary Outcomes (3)

• Evaluate for discordance in tumor volumes

  2 years

• Compare pre-radiation and follow-up C-11 methionine PET imaging in predicting sites of failure

  2 years

• Compare pre-radiation and follow-up C-11 methionine PET in predicting occurrence of pseudoprogression

  2 years

Study Arms (1)

C-11 methionine PET

EXPERIMENTAL

C-11 methionine PET pre and post radiation

Device: C-11 methionine PET

Interventions

C-11 methionine PET DEVICE

C-11 methionine PET

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Glioblastoma

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

Study Officials

• Kevin Oh, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: May 16, 2013
• First Posted: June 4, 2013
• Study Start: January 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 13, 2017

Record last verified: 2017-10

Locations

US (1)