Clinical trial · Interventional
18F-Fluorocholine (18F-FCho) to Distinguish Necrosis From Recurrence in Brain Metastases
NCT02037945CI-TRIAL-00062750completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FCH PET Scan | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- pts with brain mets going for surgery
- 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.
- interventionNames
- Procedure: 18F-FCH PET Scan
Primary outcomes (1)
- measure
- to distinguish radiation necrosis from progressive tumor
- timeFrame
- 1 year
- description
- by comparing the PET imaging results to the surgical pathology
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.