Image-Guided Stereotactic Biopsy of High Grade Gliomas

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Glioma; Brain Cancer

Treatments: Drug: 18F-FLT PET Scan

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00979810

R21CA137896-01A1 (U.S. NIH Grant/Contract)

09-060

Details and patient eligibility

About

The purpose of this study is to evaluate high and low areas of growth, or proliferation, within the tumor. An imaging technique using a very small amount of a radioactive tracer called 18Ffluoro-deoxy-L-thymidine (18F-FLT) can detect areas of rapid growth within the tumor. This imaging technique is called a FLT PET imaging. This present study involves obtaining one scan using FLT PET imaging. The goal of this study is to investigate associations between the imaging findings showing differences in growth rate within the tumor and the biology of the tumor that is measured in the sampled tumor tissue. This information may be used in future brain tumor patients to determine the best combination of treatment for individual patients. These studies may also improve our understanding of the types of changes taking place in brain tumor tissue that could improve individual patient outcome. FLT is produced for human use by the MSKCC cyclotron facility under an investigational new drug (IND) approval issued by the US Food and Drug Administration (FDA). This means that FLT is produced under strict rules and regulations, is considered safe, and has been approved for use in humans for certain disease conditions. 18F-FLT has been used in several research studies to date at this institution.

Enrollment: 11 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > or = to 18 years old.
• Radiographic appearance of a lesion presumed to be high-grade glioma.
• Planned surgical resection.

Exclusion criteria

• All patients who have been previously treated with radiation, chemotherapy, or other targeted drugs (patients only) for their brain tumor.
• Pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding.
• Patients with other active malignancies or prior treatment for non-CNS malignancies.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

18F-FLT PET scan

Experimental group

Description:

This is a pilot study intended to collect preliminary data on 15 patients diagnosed with untreated high-grade glioma who are scheduled to undergo surgical resection.

Treatment:

Drug: 18F-FLT PET Scan