Image-Guided Stereotactic Biopsy of High Grade Gliomas
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Image-Guided Stereotactic Biopsy of High Grade Gliomas|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Experimental: 18F-FLT PET scan
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.
Drug: 18F-FLT PET Scan
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00979810
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Michelle Bradbury, MD, PhD||Memorial Sloan-Kettering Cancer Center|