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Pilot Study of MET-PET (L-[Methyl]-11C Methionine Positron Emission Tomography) to Evaluate for Treatment Response After Chemoradiation Therapy for Newly-diagnosed Glioblastoma

Phase 0
18 Years
Not Enrolling

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Trial Information

Pilot Study of MET-PET (L-[Methyl]-11C Methionine Positron Emission Tomography) to Evaluate for Treatment Response After Chemoradiation Therapy for Newly-diagnosed Glioblastoma

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 part of regular cancer care and may be done even if it turns out
that you do not take part in the research study. If you have had some of these tests or
procedure recently, they may or may not have to be repeated. The screening process will
include the following: A medical history, performance status, physical exam, routine blood
tests, assessment of your tumor, diagnosis confirmation and pregnancy test. If these tests
show that you are eligible to participate in the research study, you will begin the study
treatment. If you do not meet the eligibility criteria, you will not be able to participate
in this research study.

Within 3 weeks after your surgery you will undergo a MET-PET scan to define residual
metabolic activity.

After completion of radiation therapy at 1,3,5,7,9 and 11 months following radiation therapy
you will undergo: a medical history, physical exam, assessment of your tumor by MRI,
documentation of your current dose of steroids, blood tests and an evaluation for side

At one month after the completion of radiation therapy you will undergo the second and final
MET-PET scan to assess response to therapy.

After the 11 month follow-up visit, we would like to keep track of your medical condition
for the rest of your life as part of our routine care. If we no longer see you in person in
the clinic, we would like to do this by calling you on the telephone once a year to see how
you are doing. Keeping in touch with you and checking your condition every year helps us
look at the long-term effects of the research study.

Inclusion Criteria:

- Histologically or cytologically confirmed newly-diagnosed glioblastoma or gliosarcoma
and planning to undergo standard chemoradiation treatment

- Life expectancy of at least 12 weeks

Exclusion Criteria:

- Pregnant or breastfeeding

- Glioblastoma involving the brainstem or posterior fossa, cerebrospinal fluid

- 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

- Prior use of radiosensitizers, Gliadel wafers or other interstitial intracranial

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Effect of C-11 methionine PET on progression free survival

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Kevin Oh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

May 2013

Completion Date:

Related Keywords:

  • Glioblastoma
  • Newly diagnosed
  • Glioblastoma



Massachusetts General Hospital Boston, Massachusetts  02114-2617