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Image-Guided Stereotactic Biopsy of High Grade Gliomas

Primary Purpose

Brain Cancer, Glioma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
18F-FLT PET Scan
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Cancer focused on measuring PET scan, CT scan, 09-060, CNS

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-FLT PET scan

Arm Description

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.

Outcomes

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.

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.
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.
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.

Full Information

First Posted
September 17, 2009
Last Updated
November 20, 2020
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00979810
Brief Title
Image-Guided Stereotactic Biopsy of High Grade Gliomas
Official Title
Image-Guided Stereotactic Biopsy of High Grade Gliomas
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 16, 2009 (Actual)
Primary Completion Date
February 24, 2020 (Actual)
Study Completion Date
February 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Cancer, Glioma
Keywords
PET scan, CT scan, 09-060, CNS

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18F-FLT PET scan
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
18F-FLT PET Scan
Other Intervention Name(s)
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.
Intervention Description
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 Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Bradbury, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org
Description
Memorial Sloan-Kettering Cancer Center

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Image-Guided Stereotactic Biopsy of High Grade Gliomas

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