Clinical trial · Interventional
Evaluation of 18F-fluciclovine (FACBC) PET/MR Uptake in Participants With Glioma
- 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)
This is a pilot study to assess the ability of \[F-18\]fluciclovine to differentiate pseudoprogression from progression in participants after therapy, at imaging time points within the 12 week interval post chemoradiation. \[F-18\]fluciclovine. PET will be obtained at the time point in the 12 week interval in which MRI demonstrates increase in enhancing volume with the differential diagnosis of pseudoprogression versus tumor progression. At the same time point (at least 6 hours after \[F-18\]fluciclovine or up to 3 days) F-18 FDG will also be performed consistent with standard clinical practice. The verification of pseudoprogression versus tumor progression will be determined by the regression of enhancing lesion on subsequent MRI imaging obtained as part of standard care.
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 |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-fluciclovine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participants with Glioma
- description
- \[F18\]fluciclovine will be utilized to assess tumor viability compared with F-18 FDG PET or diagnostic MRI.
- interventionNames
- Drug: 18F-fluciclovine
Primary outcomes (1)
- measure
- To assess the ability of [F-18]fluciclovine to differentiate radionecrosis (pseudoprogression) from tumor recurrence (progression) in patients after therapy, at imaging time points within the 12 week interval post chemoradiation.
- timeFrame
- 90 minutes
- description
- To assess the ability of \[F-18\]fluciclovine to differentiate pseudoprogression from progression as compared to F-18 FDG, regions of interest will be drawn around MRI anatomically defined enhancing tumor regions and translated to both the F-18 FDG and F-18 fluciclovine PET scans to obtain SUV for each tracer. The SUV values will be correlated with the diagnosis of pseudoprogression versus tumor progression as determined by the regression of lesion enhancement on subsequent standard clinical follow up MRI imaging, as described in the protocol.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Age ≥ 18 years old. 2\. Been previously diagnosed by resection or biopsy with grade 3 or 4 glioma. 3\. Agree to use adequate contraception as indicated in this protocol. 4\. Consent to PET scanning and receipt of one injection of 18F-fluciclovine. 5\. Able to comply with study procedures. 6\. Able to give written consent. 7\. Subject has had a standard of care, diagnostic MRI study which was indeterminate due to the inability to differentiate pseudoprogression versus tumor progression. Exclusion Criteria: * 1\. Are a pregnant or breastfeeding female. 2\. Are participating in a clinical trial of another unlicensed product. 3\. Are undergoing 18F-fluciclovine PET for reason(s) other than newly diagnosed or recurrent glioma. 4\. Have a hypersensitivity to 18F-fluciclovine. 5\. Have acute renal failure or moderate/severe renal impairment, according to local clinical guidelines. 6\. Have a non-MRI compatible implantable device or another contraindication for MRI scan. 7\. Are deemed ineligible to participate for other reasons by an investigator.
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