Evaluating Tumor Pseudoprogression With FLT-PET and MRI

NCT01105988 | Terminated Early Phase 1 DMC

• 1 other identifier: 10-008
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma

Keywords

GBM; PET scans; MRI scans

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Secondary Outcome Measure

  2 years

• Secondary Outcome Measure

  2 years

• Secondary Outcome Measure

  2 years

Interventions

Radiologic exams OTHER

FLT PET scan x 2 MRI scan x 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Dana-Farber Cancer Institute: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Elizabeth Gerstner, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: April 19, 2010
• Study Start: May 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 6, 2012

Record last verified: 2012-01

Locations

US (1)