Clinical trial · Interventional
Study of Laser Interstitial Thermal Therapy (LITT) Treatment Response Assessment With Fluciclovine PET MR
NCT05054400CI-TRIAL-00069272withdrawnEarly Phase 1ClinicalTrials.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): 0 participant accrual
Summary
Brief summary (as posted)
The purpose of this study is to assess the relationship between brain malignancy volume as defined by post-contrast T1 weighted and F18 Fluciclovine before and following LITT. We hypothesize that imaging with F18 Fluciclovine will be superior to anatomic MR imaging in lesion volume assessment before treatment and that residual F18 Fluciclovine defined tumor will predict local post-LITT disease recurrence.
Conditions
Conditions (4)
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 | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Gliomas | Glioma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| F18 Fluciclovine | Drug | — | UNRESOLVED |
| Standard of Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- F18 Fluciclovine
- description
- radioactive imaging agent help researchers better "see" how the disease is responding to laser interstitial thermal therapy (LITT)
- interventionNames
- Drug: F18 Fluciclovine
- Other: Standard of Care
Primary outcomes (1)
- measure
- To establish the relationship between brain malignancy volume as defined by post-contrast T1 weighted and F18 Fluciclovine before and following LITT.
- timeFrame
- through study completion, an average of 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * An adult patient with suspected or pathology-proven central nervous system neoplasm. * MRI of the brain, positive for at least one intra-axial lesion greater than 5 mm. Exclusion Criteria * Contraindication to MR imaging. * Known allergy to gadolinium-based contrast agents. * Renal failure as defined by a GFR less than 30 or the use of hemodialysis. * Pregnant. * Patients less than 18 years of age will be excluded.
References
Publications (0)
Data not yet available
No reference posted for this study.