Overview

This trial is active, not recruiting.

Conditions brain cancer, glioma
Treatment 18f-flt pet scan
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator National Cancer Institute (NCI)
Start date September 2009
End date September 2016
Trial size 15 participants
Trial identifier NCT00979810, 09-060, R21CA137896-01A1

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
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.
18f-flt pet scan As part of the standard surgical care for brain cancer, the patient will undergo
The patient will undergo MRI and 18F-FLT PET scans of the brain. A IV catheter will be placed in a superficial hand or arm vein for administration of 18F-FLT (approximately 370 MBq), prepared by the MSKCC Radiochemistry Core Facility. A second venous catheter will be placed in the opposite hand or arm for venous blood sampling. If a central venous catheter is present, it will be used for blood sampling or radiopharmaceutical administration, and only a single venous catheter will be placed. Sequential blood samples may be obtained following 18F-FLT infusion for assaying whole blood and plasma radioactivity. All catheters will be removed at the end of the day.

Primary Outcomes

Measure
invest relation btw voxel-based determ of prolif rate & obser MR imaging featu (i.e., Ktrans or microvas permeabil; fBV, tiss fract blood vol), as well with spatially reg histolog meas of tum cell prolif (Ki67) & microvas density (CD31) at corres locat.
time frame: 2 years

Secondary Outcomes

Measure
Attempt to corroborate voxel-based parameter estimates reflecting tumor cell proliferation with estimates derived using standard ROI-based pharmaco modeling methods, for improving the characterization of high-grade gliomas using dynamic 18F-FLT PET-CT.
time frame: 2 years
Assess whether static meas of 18F-FLT uptake can ade serve as non-invasive biomarker of prolif act or whether parametric images, based on compart analys of FLT pharmas, are req by correl find of both appro with region histol assays of tum cell prolife.
time frame: 2 years
Evaluate whether differ in gene expression seen between areas of increas & decreas proliferative activity on parametric maps define consistent differential transcriptome signatures for comparison with known molecular subclasses of GBM & known pathways.
time frame: 2 years

Eligibility Criteria

Male or female participants from 18 years up to 89 years old.

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.

Additional Information

Official title Image-Guided Stereotactic Biopsy of High Grade Gliomas
Principal investigator Michelle Bradbury, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.