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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Brain Metastases

Treatments: Procedure: 18F-FCH PET Scan

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02037945

13-199

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

pts with brain mets going for surgery

Experimental group

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.

Treatment:

Procedure: 18F-FCH PET Scan