Evaluating Tumor Pseudoprogression With FLT-PET and MRI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01105988
Recruitment Status : Terminated (Funding ended)
First Posted : April 19, 2010
Last Update Posted : January 6, 2012
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Elizabeth R. Gerstner, MD, Massachusetts General Hospital

Brief Summary:

A standard treatment for glioblastoma is a combination of radiation and the drug temozolomide. This combination sometimes causing swelling (inflammation) of the brain tissue. When standard monitoring with MRI or CT scans is done within a few months of finishing treatment, it may be hard to tell if the scans are showing post-treatment brain inflammation or tumor growth and worsening of disease. Currently the only way to definitively distinguish inflammation from tumor growth is biopsy.

However, biopsy is an invasive procedure that is associated with risks. Having a non-invasive method to distinguish post-treatment inflammation from tumor growth can help improve care for patients with glioma.

For the PET scans in this research study, the investigators are using a radioactive substance called FLT (3'-deoxy-3'-[F-18] fluorothymidine), instead of the standard substance FDG (fluorodeoxyglucose). FLT gets absorbed by cancer cells but not by areas of inflammation. Because of that FLT may be better than FDG in differentiating cancer cells from inflammation.

An MRI scan will also be done at the same time as each of the 2 FLT-PET scans done for this research study. The two MRI scans performed will also help give more information about the patient's tumor that is not routinely provided with a routine clinical scan, such as blood flow through the tumor or metabolic activity in the tumor. The information from these special MRI scans may provide more information about the blood supply to the tumor and how this changes in response to treatment. In addition, the MRI scans along with the FLT-PET scans may help how to distinguish inflammation due to radiation therapy from tumor growth.

Condition or disease Intervention/treatment Phase
Glioblastoma Other: Radiologic exams Early Phase 1

Detailed Description:

If you are eligible to participate in this study you will have a pre-treatment FLT-PET scan within 7 days before starting treatment with radiation and temozolomide.

Two intravenous catheters (IVs) will be placed for each scan. One IV will be used to inject the FLT for the PET scan and the contrast agent for the MRI scan. The second IV will be used to draw blood for research tests. The PET scan will take about 2 hours. The MRI scan will take about 60-75 minutes. They will be done simultaneously.

About 4 weeks after you finish radiation therapy you will have a second FLT-PET scan and MRI scan.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study to Evaluate Tumor Pseudoprogression With FLT-PET and MRI
Study Start Date : May 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Other: Radiologic exams
    FLT PET scan x 2 MRI scan x 2

Primary Outcome Measures :
  1. Primary Outcome Measure [ Time Frame: 2 years ]
    To determine if elevated FLT PET uptake 4 weeks after completion of chemoradiation is associated with early tumor growth rather than treatment effect in patients with newly diagnosed glioblastome treated with standard chemoradiation.

Secondary Outcome Measures :
  1. Secondary Outcome Measure [ Time Frame: 2 years ]
    To clarify the impact of radiation and temozolomide chemotherapy on tumor cell proliferation.

  2. Secondary Outcome Measure [ Time Frame: 2 years ]
    To compare blood-derived kinetic parameters of tumor cell proliferation rate with image derived parameters of proliferation.

  3. Secondary Outcome Measure [ Time Frame: 2 years ]
    To examine the association of FLT uptake and MRI parameters, specifically contrast enhancement, perfusion, permeability, diffusion, and MR Spectroscopy.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed newly diagnosed glioblastoma
  • Planned treatment for glioblastoma is standard radiation and temozolomide
  • Measurable disease
  • Life expectancy >/= 12 weeks
  • Lab values must be within limits specified in protocol
  • Able to undergo MRI and PET scans
  • On stable dose of steroids for 5 days prior to each MRI scan

Exclusion Criteria:

  • Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering study or not recovered from adverse events from prior therapy
  • Receiving any other study agents to treat tumor
  • History of allergic reactions to compounds of similar chemical or biologic composition to FLT
  • Uncontrolled intercurrent illness
  • Pregnant or nursing
  • HIV-positive

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01105988

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Principal Investigator: Elizabeth Gerstner, MD Massachusetts General Hospital

Responsible Party: Elizabeth R. Gerstner, MD, Principal Investigator, Massachusetts General Hospital Identifier: NCT01105988     History of Changes
Other Study ID Numbers: 10-008
First Posted: April 19, 2010    Key Record Dates
Last Update Posted: January 6, 2012
Last Verified: January 2012

Keywords provided by Elizabeth R. Gerstner, MD, Massachusetts General Hospital:
PET scans
MRI scans

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue