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

Not Applicable

Completed

• Conditions: Brain Metastases
• Interventions: Procedure: 18F-FCH PET Scan

• Registration Number: NCT02037945
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-14
• Study First Posted: 2014-01-16
• Status Verified: 2022-12
• Primary Completion: 2022-12-08
• Study Completion: 2022-12-08
• Last Update Submitted: 2022-12-15
• Last Update Posted: 2022-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pts with brain mets going for surgery	18F-FCH PET Scan	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.

Primary Outcome Measures

Name	Time	Method
to distinguish radiation necrosis from progressive tumor	1 year	by comparing the PET imaging results to the surgical pathology

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States