Clinical trial · Observational
FLT PET/MR for Evaluation of Pseudoprogression in Patients With Brain Lesions
NCT02328300CI-TRIAL-00035771withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): FLT production not available
Summary
Brief summary (as posted)
This is a single arm, single center study of 15 patients with brain lesions being treated at UNC Hospitals. Subjects will undergo one (1) FLT-PET-MRI scan before their scheduled surgical biopsy of their brain lesion(s).
Conditions
Conditions (3)
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 Lesions | — | UNRESOLVED | — |
| Brain Metastases | — | UNRESOLVED | — |
| Brain Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FLT PET/MR | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- FLT PET/MR
- description
- All participants will have known brain lesion in the central nervous system (CNS) scheduled to have surgical biopsy of the lesion, identified by the UNC Brain Tumor Board and will have the clinical question of radiation necrosis vs. recurrence. All participants will receive a FLT PET/MR scan.
- interventionNames
- Drug: FLT PET/MR
Primary outcomes (1)
- measure
- Sensitivity and specificity of FLT-PET-MRI in distinguishing between recurrence and radiation necrosis, with surgical biopsy as gold standard
- timeFrame
- 1 week post-surgical biopsy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Known brain lesion in central nervous system (CNS) scheduled to have surgical biopsy of the lesion, identified by the UNC Brain Tumor Board as having clinical question of radiation necrosis vs. recurrence * At least one measurable lesion greater than 1 cm in diameter * ≥ 18 years of age * Study-specific informed consent reviewed and signed Exclusion Criteria: * Pregnant, nursing, or planning to become pregnant within 30 days of anticipated PET-MRI scan * Condition that makes MRI unsafe (e.g., cardiac pacemaker, epicardial pacemaker leads, cochlear implants, metal aneurysm clips, metal halo devices) * Inability to tolerate MRI (e.g., unable to lie flat for \> 1 hour, severe claustrophobia) * Allergy to MRI contrast agent (Magnevist, Multihance, Ablavar, Dotarem, Eovist, Gadavist) * Known allergy to fluorothymidine * Study participation would cause significant delay (\> 2 weeks) in scheduled standard of care therapy * Creatinine clearance \< 60 ml/min, as estimated by the Cockcroft-Gault formula * Body Mass Index (BMI) \> 35 * Poorly controlled diabetes mellitus (fasting blood glucose \> 200 mg/dl)
References
Publications (0)
Data not yet available
No reference posted for this study.