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 Overview

• Status: Completed
• Conditions: Glioma; Brain Cancer
• Intervention / Treatment: Drug: 18F-FLT PET Scan

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.; Other Names: As part of the standard surgical care for brain cancer, the patient will undergo; biopsy of the tumor. A few small tissue samples will be collected from different; sites within the tumor and used for examining the biology of the tumor tissue.; Associations will be made between the 18F-FLT imaging findings at these biopsy; sites, which reflect differences in tumor growth rate, and the corresponding; biology of the tumor measured in the sampled tumor tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	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.	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.	2 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Michelle Bradbury, MD, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan-Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2009
• Primary Completion (Actual): February 24, 2020
• Study Completion (Actual): February 24, 2020

Study Registration Dates

• First Submitted: September 17, 2009
• First Submitted That Met QC Criteria: September 17, 2009
• First Posted (Estimate): September 18, 2009

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: November 20, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: PET scan; CNS; CT scan; 09-060
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Glioma; Brain Neoplasms; Anti-Infective Agents; Antiviral Agents; Alovudine
• Other Study ID Numbers: 09-060; R21CA137896-01A1 (U.S. NIH Grant/Contract)