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

NCT02037945 | Completed

• 1 other identifier: 13-199
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Metastases

Keywords

18F-Fluorocholine (18F-FCho); Pet Scan; MRI; 13-199

Outcome Measures

Primary Outcomes (1)

• to distinguish radiation necrosis from progressive tumor

  by comparing the PET imaging results to the surgical pathology

  1 year

Study Arms (1)

pts with brain mets going for surgery

EXPERIMENTAL

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.

Procedure: 18F-FCH PET Scan

Interventions

18F-FCH PET Scan PROCEDURE

pts with brain mets going for surgery

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Inability to undergo a MRI or PET scan (e.g., claustrophobia or metal implant)
• Pregnant or nursing female
• Unable to cooperate for PET/CT

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Kathryn Beal, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 16, 2014
• Study Start: January 1, 2014
• Primary Completion: December 8, 2022
• Study Completion: December 8, 2022
• Last Updated: December 19, 2022

Record last verified: 2022-12

Locations

US (1)