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A Pilot Study to Evaluate Tumor Pseudoprogression With FLT-PET and MRI


Phase 0
18 Years
N/A
Not Enrolling
Both
Glioblastoma

Thank you

Trial Information

A Pilot Study to Evaluate Tumor Pseudoprogression With FLT-PET and MRI


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Primary Outcome Measure

Outcome 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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Elizabeth Gerstner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

10-008

NCT ID:

NCT01105988

Start Date:

May 2011

Completion Date:

October 2011

Related Keywords:

  • Glioblastoma
  • GBM
  • PET scans
  • MRI scans
  • Glioblastoma

Name

Location
Massachusetts General Hospital Boston, Massachusetts  02114-2617