Evaluating Tumor Pseudoprogression With FLT-PET and MRI

Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01105988
• Other study ID #: 10-008
• Status: Terminated
• Phase: Phase 0
• First received: April 15, 2010
• Last updated: January 4, 2012
• Start date: May 2011
• Est. completion date: October 2011

Study information

• Verified date: January 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Other:
• Radiologic exams
FLT PET scan x 2 MRI scan x 2

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years	No
Secondary	Secondary Outcome Measure	To clarify the impact of radiation and temozolomide chemotherapy on tumor cell proliferation.	2 years	No
Secondary	Secondary Outcome Measure	To compare blood-derived kinetic parameters of tumor cell proliferation rate with image derived parameters of proliferation.	2 years	No
Secondary	Secondary Outcome Measure	To examine the association of FLT uptake and MRI parameters, specifically contrast enhancement, perfusion, permeability, diffusion, and MR Spectroscopy.	2 years	No