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Evaluating Tumor Pseudoprogression With FLT-PET and MRI

Primary Purpose

Glioblastoma

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Radiologic exams
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glioblastoma focused on measuring GBM, PET scans, MRI scans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Outcomes

Primary Outcome Measures

Primary Outcome Measure
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

Secondary Outcome Measure
To clarify the impact of radiation and temozolomide chemotherapy on tumor cell proliferation.
Secondary Outcome Measure
To compare blood-derived kinetic parameters of tumor cell proliferation rate with image derived parameters of proliferation.
Secondary Outcome Measure
To examine the association of FLT uptake and MRI parameters, specifically contrast enhancement, perfusion, permeability, diffusion, and MR Spectroscopy.

Full Information

First Posted
April 15, 2010
Last Updated
January 4, 2012
Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01105988
Brief Title
Evaluating Tumor Pseudoprogression With FLT-PET and MRI
Official Title
A Pilot Study to Evaluate Tumor Pseudoprogression With FLT-PET and MRI
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Terminated
Why Stopped
Funding ended
Study Start Date
May 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
Keywords
GBM, PET scans, MRI scans

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Radiologic exams
Intervention Description
FLT PET scan x 2 MRI scan x 2
Primary Outcome Measure Information:
Title
Primary Outcome Measure
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Secondary Outcome Measure
Description
To clarify the impact of radiation and temozolomide chemotherapy on tumor cell proliferation.
Time Frame
2 years
Title
Secondary Outcome Measure
Description
To compare blood-derived kinetic parameters of tumor cell proliferation rate with image derived parameters of proliferation.
Time Frame
2 years
Title
Secondary Outcome Measure
Description
To examine the association of FLT uptake and MRI parameters, specifically contrast enhancement, perfusion, permeability, diffusion, and MR Spectroscopy.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Gerstner, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Evaluating Tumor Pseudoprogression With FLT-PET and MRI

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