Clinical trial NCT00979810: Image-Guided Stereotactic Biopsy of High Grade Gliomas
Official title: Image-Guided Stereotactic Biopsy of High Grade Gliomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Cancer
Glioma
Keywords: PET scan
CT scan
09-060
CNS
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-09-18
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility 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.

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.
timeFrame: 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.
timeFrame: 2 years
measure: 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.
timeFrame: 2 years
measure: 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.
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Michelle Bradbury, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: