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

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.

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Key information

Conditions

Brain Metastases Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18F-FCH PET Scan

Procedure

Primary outcomes

to distinguish radiation necrosis from progressive tumor

Time frame: 1 year

by comparing the PET imaging results to the surgical pathology

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

National Institutes of Health (NIH)

Registry information

Important dates

Study start: 2014
Primary completion: 2022
Study completion: 2022
First posted: Jan 16, 2014
Registry last updated: Dec 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed