Clinical trial · Observational
18F-fluciclovine PET/MRI Imaging for the Detection of Tumor Recurrence After Radiation Injury to the Brain
18F-Fluciclovine PET Discrimination of Radiation Injury to the Brain
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow enrollment
Summary
Brief summary (as posted)
This phase I trial studies the ability and amount of fluciclovine positron emission tomography (PET) imaging needed to recognize tumors that have come back (recurrence) after brain injury from radiation therapy (radionecrosis) in patients with intracranial disease that has spread to other places in the body (metastatic). F-18 fluciclovine is a radiotracer that works by accumulating in tumor cells, making it easier to detect tumors. The results of this study may also help investigators understand all the ways that F-18 fluciclovine may affect patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Intracranial Malignant Neoplasm | Brain Neoplasm | PROBABILISTIC | 0.70 |
| Recurrent Intracranial Neoplasm | Intracranial Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Positron Emission Tomography | Radiation | — | UNRESOLVED |
| Fluciclovine F18 | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Diagnostic (18F-fluciclovine, PET/MRI imaging)
- description
- Patients receive fluciclovine IV and undergo brain dynamic PET/MRI imaging over 50 minutes.
- interventionNames
- Radiation: Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Positron Emission Tomography
- Other: Fluciclovine F18
Primary outcomes (1)
- measure
- Tumor-to-background ratios (TBR)max and TBRmean thresholds
- timeFrame
- Up to 4 weeks post study registration
- description
- Will be estimated to delineate tumor progression from radionecrosis for use in future studies. The optimal TBRmax and TBRmean thresholds will be chosen as the threshold with the best cutpoint/threshold during a Receiver Operating Characteristics analysis corresponding to the maximum area under the curve (AUC) value when both the sensitivity and specificity are greater than 85%.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Clinical evidence of intracranial metastatic disease which underwent radiation and who presents with MRI findings suspicious for recurrent disease and/or radionecrosis (namely the 'index lesion') Exclusion Criteria: * Contraindication to contrast enhanced MRI * Females of child-bearing potential who are pregnant or lactating or who are not using adequate contraception (surgical, hormonal or double barrier, i.e. condom and diaphragm) * Inability to lie still for 50 minutes during fluciclovine PET-MRI imaging * Inability or refusal to consent * Allergy or anaphylaxis to any of the reagents used in this study * Inability or unwillingness to return for required visits and follow-up exams
References
Publications (1)
- DERIVEDKotecha R, Aboian M, Nabavizadeh SA, Parent EE, Trifiletti DM, Chao ST. Letter regarding "Contribution of PET imaging to radiotherapy planning and monitoring in glioma patients-a report of the PET/RANO group": 18F-fluciclovine and target volume delineation. Neuro Oncol. 2021 Aug 2;23(8):1408-1409. doi: 10.1093/neuonc/noab097. No abstract available. PMID 34081125