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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02037945
Enrollment
19
Registered
2014-01-16
Start date
2014-01-31
Completion date
2022-12-08
Last updated
2022-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Metastases

Keywords

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

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.

Interventions

PROCEDURE18F-FCH PET Scan

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
to distinguish radiation necrosis from progressive tumor1 yearby comparing the PET imaging results to the surgical pathology

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026