Image-Guided Stereotactic Biopsy of High Grade Gliomas

• Sponsor: Memorial Sloan Kettering Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00979810
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 11
• Location: 1
• Arm: 1
• Actual Duration (Months): 125.3
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Cancer; Glioma	Drug: 18F-FLT PET Scan	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Image-Guided Stereotactic Biopsy of High Grade Gliomas
• Actual Study Start Date: Sep 16, 2009
• Actual Primary Completion Date: Feb 24, 2020
• Actual Study Completion Date: Feb 24, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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]

2. 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]

3. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10065

Sponsors and Collaborators

• Memorial Sloan Kettering Cancer Center
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Michelle Bradbury, MD, PhD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 27, 2011

More Information

Additional Information:

• Memorial Sloan-Kettering Cancer Center

Publications

None provided.

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT00979810
• Other Study ID Numbers: 09-060; R21CA137896-01A1
• First Posted: Sep 18, 2009
• Last Update Posted: Dec 17, 2020
• Last Verified: Feb 1, 2020

• Keywords provided by Memorial Sloan Kettering Cancer Center: PET scan; CT scan; 09-060; CNS
• Additional relevant MeSH terms: Glioma; Brain Neoplasms; Alovudine

Study Results

Participant Flow

Arm/Group Title	18F-FLT PET Scan
Arm/Group 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. 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.
Period Title: Overall Study
STARTED	11
COMPLETED	11
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	18F-FLT PET Scan
Arm/Group 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. 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.
Overall Participants	11
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	57
Sex: Female, Male (Count of Participants)
Female	4 36.4%
Male	7 63.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	11 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	11 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	11 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	18F-FLT PET Scan
Arm/Group 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. 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.
Measure Participants	0

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	18F-FLT PET Scan
Arm/Group 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. 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.
Measure Participants	0

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	18F-FLT PET Scan
Arm/Group 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. 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.
Measure Participants	0

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	18F-FLT PET Scan
Arm/Group 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. 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.
Measure Participants	0

Adverse Events

Time Frame	2 years
Arm/Group Title	18F-FLT PET Scan
Arm/Group 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. 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.
All Cause Mortality
	18F-FLT PET Scan
	Affected / at Risk (%)	# Events
Total	11/11 (100%)
Serious Adverse Events
	18F-FLT PET Scan
	Affected / at Risk (%)	# Events
Total	0/11 (0%)
Other (Not Including Serious) Adverse Events
	18F-FLT PET Scan
	Affected / at Risk (%)	# Events
Total	0/11 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.