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Fluciclovine PET/CT
Fluciclovine is a fluorine-18 labeled amino acid analog that accumulates in cancer cells with high amino acid metabolism, enabling PET/CT imaging detection of malignant lesions.
Fluciclovine is a fluorine-18 labeled amino acid analog that accumulates in cancer cells with high amino acid metabolism, enabling PET/CT imaging detection of malignant lesions. Used for PET imaging of suspected prostate cancer recurrence in men with elevated PSA, Detection and localization of various malignancies with high amino acid metabolism.
At a glance
| Generic name | Fluciclovine PET/CT |
|---|---|
| Also known as | 18F-FACBC, Axumin® |
| Sponsor | OHSU Knight Cancer Institute |
| Drug class | PET imaging agent |
| Target | Amino acid transporters (LAT1, ASCT2) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
Fluciclovine (18F-FACBC) is taken up preferentially by cancer cells due to their elevated amino acid transport and metabolism compared to normal tissue. The fluorine-18 radiolabel allows positron emission tomography (PET) imaging to visualize areas of increased uptake, which correlates with malignant disease. This mechanism enables improved detection and localization of tumors for diagnostic and staging purposes.
Approved indications
- PET imaging of suspected prostate cancer recurrence in men with elevated PSA
- Detection and localization of various malignancies with high amino acid metabolism
Common side effects
- Injection site reactions
- Radiation exposure (expected from PET tracer)
Key clinical trials
- A Study Using Nivolumab, in Combination With Chemotherapy Drugs to Treat Nasopharyngeal Carcinoma (NPC) (PHASE2)
- Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging (PHASE3)
- 18F-Fluciclovine PET/CT in Multiple Myeloma (PHASE2)
- Assess Use of 18F-Fluciclovine for Patients With Large Brain Metastases Treated With Staged Stereotactic Radiosurgery (PHASE1)
- 18Fluorine-Fluciclovine PET/CT for Staging Muscle Invasive Bladder Cancer Preceding Radical Cystectomy (EARLY_PHASE1)
- Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer, The NRG Promethean Study (PHASE2)
- Prostate Specific Membrane Antigen (PSMA) or (FACBC) PET/CT Site-Directed Therapy for Treatment of Prostate Cancer, Flu-BLAST-PC Study (PHASE2)
- Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Resected Brain Metastasis (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Fluciclovine PET/CT CI brief — competitive landscape report
- Fluciclovine PET/CT updates RSS · CI watch RSS
- OHSU Knight Cancer Institute portfolio CI