Back to results18F-Fluorocholine (18F-FCho) to Distinguish Necrosis From Recurrence in Brain Metastases
Primary Purpose
Brain Metastases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
18F-FCH PET Scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Brain Metastases focused on measuring 18F-Fluorocholine (18F-FCho), Pet Scan, MRI, 13-199
Eligibility Criteria
Inclusion Criteria:
- Patient and/or guardian is able to provide written informed consent prior to study registration
- Age ≥ 21 years old
- Evolving brain lesions post SRS requiring neurosurgical resection (whether for symptomatic control or to establish pathology)
Exclusion Criteria:
- Inability to undergo a MRI or PET scan (e.g., claustrophobia or metal implant)
- Pregnant or nursing female
- Unable to cooperate for PET/CT
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
pts with brain mets going for surgery
Arm Description
This study will enroll patients with brain metastases that are evolving after SRS who are scheduled to undergo surgical resection. Eligible patients will undergo an 18F-FCH PET study 1-to-7 days pre-operatively. Although no toxicity has been previously reported following 18F-FCH administration, patients will be contacted 1-3 days after their scan and asked whether they experienced any adverse effects. The patients who have a positive 18F-FCH PET study (in which there is visible focal "hot spots" (a focus of lesion/normal white matter ratio >1.4) of 18F-FCH) will undergo further evaluation and be administered a second administration oflower activity 18F-FCH at the time of surgery. The purpose of the second 18F-FCH administration in the operating room is to further elucidate the tissue distribution of 18F-FCH radioactivity with respect to the histopathology of the surgically resected tissue.
Outcomes
Primary Outcome Measures
to distinguish radiation necrosis from progressive tumor
by comparing the PET imaging results to the surgical pathology
Secondary Outcome Measures
Full Information
NCT ID
NCT02037945
First Posted
January 14, 2014
Last Updated
December 15, 2022
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT02037945
Brief Title
18F-Fluorocholine (18F-FCho) to Distinguish Necrosis From Recurrence in Brain Metastases
Official Title
18F-Fluorocholine (18F-FCho) to Distinguish Necrosis From Recurrence in Brain Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
December 8, 2022 (Actual)
Study Completion Date
December 8, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Institutes of Health (NIH)
4. Oversight
5. Study Description
Brief Summary
The main purpose of this study is to determine the distribution of 18F Fluorocholine (18F-FCH) in the brain which can help distinguishing radiation-induced scarring from tumor regrowth. In addition, the study will measure levels of 18F-FCH in the blood and (if applicable) in the brain lesion tissue that is removed as part of the planned brain surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases
Keywords
18F-Fluorocholine (18F-FCho), Pet Scan, MRI, 13-199
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pts with brain mets going for surgery
Arm Type
Experimental
Arm Description
This study will enroll patients with brain metastases that are evolving after SRS who are scheduled to undergo surgical resection. Eligible patients will undergo an 18F-FCH PET study 1-to-7 days pre-operatively. Although no toxicity has been previously reported following 18F-FCH administration, patients will be contacted 1-3 days after their scan and asked whether they experienced any adverse effects. The patients who have a positive 18F-FCH PET study (in which there is visible focal "hot spots" (a focus of lesion/normal white matter ratio >1.4) of 18F-FCH) will undergo further evaluation and be administered a second administration oflower activity 18F-FCH at the time of surgery. The purpose of the second 18F-FCH administration in the operating room is to further elucidate the tissue distribution of 18F-FCH radioactivity with respect to the histopathology of the surgically resected tissue.
Intervention Type
Procedure
Intervention Name(s)
18F-FCH PET Scan
Primary Outcome Measure Information:
Title
to distinguish radiation necrosis from progressive tumor
Description
by comparing the PET imaging results to the surgical pathology
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient and/or guardian is able to provide written informed consent prior to study registration
Age ≥ 21 years old
Evolving brain lesions post SRS requiring neurosurgical resection (whether for symptomatic control or to establish pathology)
Exclusion Criteria:
Inability to undergo a MRI or PET scan (e.g., claustrophobia or metal implant)
Pregnant or nursing female
Unable to cooperate for PET/CT
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn Beal, MD
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
Learn more about this trial
18F-Fluorocholine (18F-FCho) to Distinguish Necrosis From Recurrence in Brain Metastases
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