Status:

COMPLETED

MET-PET for Newly Diagnosed Glioblastoma

Lead Sponsor:

Massachusetts General Hospital

Conditions:

Glioblastoma

Eligibility:

All Genders

18+ years

Phase:

EARLY_PHASE1

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 ef...

Detailed Description

After agreeing to take part in this research study you will be asked to undergo some screening tests or procedures to confirm that you are eligible. Many of these tests and procedures are likely to be...

Eligibility Criteria

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

  • 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

Key Trial Info

Start Date :

January 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2016

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT01867593

Start Date

January 1 2014

End Date

September 1 2016

Last Update

October 13 2017

Active Locations (1)

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1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114