Image-Guided Stereotactic Biopsy of High Grade Gliomas

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00979810
First received: September 17, 2009
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Brain Cancer
Glioma
Drug: 18F-FLT PET Scan

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 15
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)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00979810

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Michelle Bradbury, MD, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00979810     History of Changes
Other Study ID Numbers: 09-060, R21CA137896-01A1
Study First Received: September 17, 2009
Last Updated: August 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
PET scan
CT scan
09-060
CNS

Additional relevant MeSH terms:
Brain Neoplasms
Glioma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Alovudine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014