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NCT02037945 Clinical Trial

18F-Fluorocholine (18F-FCho) to Distinguish Necrosis From Recurrence in Brain Metastases

Brain Metastases Clinical Trial

Official title:
18F-Fluorocholine (18F-FCho) to Distinguish Necrosis From Recurrence in Brain Metastases

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02037945
Other study ID # 13-199
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2014
Est. completion date December 8, 2022

Study information
Verified date December 2022
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 19
Est. completion date December 8, 2022
Est. primary completion date December 8, 2022
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• 18F-FCH PET Scan

Locations
Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (2)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary to distinguish radiation necrosis from progressive tumor by comparing the PET imaging results to the surgical pathology 1 year
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