Fluciclovine (18F)
- Generic Name
- Fluciclovine (18F)
- Brand Names
- Axumin
- Drug Type
- Small Molecule
- Chemical Formula
- C5H8FNO2
- CAS Number
- 222727-39-1
- Unique Ingredient Identifier
- 38R1Q0L1ZE
- Background
Fluciclovine is a [18F]-tagged synthetic analog of the amino acid L-leucine. It presents excellent diagnostic properties to be used in positron emission tomography (PET) imaging. The structure of fluciclovine allows it to be uptaken by the tumoral cells by its amino acid transporter without incorporating in the metabolism within the body. Fluciclovine was developed by Blue Earth Diagnostics, Ltd. and FDA approved in May 27, 2016.
- Indication
Fluciclovine is indicated as a detection agent for positron emission tomography (PET) in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. The overexpression of L-type amino acid transporters such as LAT1 and LAT3 that mediate the uptake of essential amino acids has been extensively reported as a tumoral mechanism of cell growth.
- Associated Conditions
- Prostate Cancer
Multitracer [18F]Fluciclovine and 18F-FDG PET, and Advanced MRI for Metabolic Profiling of Glioblastoma
- Conditions
- GlioblastomaRecurrent GlioblastomaGlioblastoma Multiforme of Brain
- Interventions
- First Posted Date
- 2024-09-26
- Last Posted Date
- 2025-05-08
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- Target Recruit Count
- 15
- Registration Number
- NCT06613841
- Locations
- 🇺🇸
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
🇺🇸University of Pennsylvania, Philadelphia, Pennsylvania, United States
Pilot Study for Detection of PSMA-Low CRPC-NE Tumors with Fluciclovine PET/CT
- Conditions
- Metastatic Prostate Neuroendocrine CarcinomaAdvanced Prostate CancerMetastatic Prostate Cancer
- Interventions
- Device: PET/CT
- First Posted Date
- 2023-10-02
- Last Posted Date
- 2025-02-05
- Lead Sponsor
- Brigham and Women's Hospital
- Target Recruit Count
- 30
- Registration Number
- NCT06062745
- Locations
- 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸Brigham and Womens Hospital, Boston, Massachusetts, United States
Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG
- Conditions
- GliomaLow-grade GliomaLow Grade Glioma of BrainGlioma, MalignantGlioma Intracranial
- Interventions
- First Posted Date
- 2022-09-27
- Last Posted Date
- 2025-02-24
- Lead Sponsor
- Children's Hospital of Philadelphia
- Target Recruit Count
- 30
- Registration Number
- NCT05555550
- Locations
- 🇺🇸
The Children s Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Resected Brain Metastasis
- First Posted Date
- 2022-09-26
- Last Posted Date
- 2024-10-18
- Lead Sponsor
- Baptist Health South Florida
- Target Recruit Count
- 20
- Registration Number
- NCT05554302
- Locations
- 🇺🇸
Miami Cancer Institute at Baptist Health South Florida, Miami, Florida, United States
18F-Fluciclovine PET-MRI in High-grade Glioma
- Conditions
- Diffuse GliomaGliomaHigh Grade GliomaGlioma IntracranialGlioma, Malignant
- Interventions
- First Posted Date
- 2022-09-23
- Last Posted Date
- 2024-10-08
- Lead Sponsor
- Children's Hospital of Philadelphia
- Target Recruit Count
- 30
- Registration Number
- NCT05553041
- Locations
- 🇺🇸
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
18F-Fluciclovine PET/CT in the Assessment of Pancreatic Transplants
- Conditions
- Pancreatitis, GraftPancreatic Transplant Post-Transplant Dysfunction Rejection
- Interventions
- First Posted Date
- 2021-04-21
- Last Posted Date
- 2024-01-17
- Lead Sponsor
- University of Utah
- Target Recruit Count
- 4
- Registration Number
- NCT04852523
- Locations
- 🇺🇸
University of Utah Hospital, Salt Lake City, Utah, United States
Fluciclovine and PSMA PET/CT for the Classification and Improved Staging of Invasive Lobular Breast Cancer
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8Metastatic Breast Lobular CarcinomaInvasive Breast Lobular CarcinomaPrognostic Stage IV Breast Cancer AJCC v8
- Interventions
- Procedure: Computed TomographyProcedure: Positron Emission Tomography
- First Posted Date
- 2021-02-11
- Last Posted Date
- 2025-01-17
- Lead Sponsor
- Emory University
- Target Recruit Count
- 20
- Registration Number
- NCT04750473
- Locations
- 🇺🇸
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
An Investigational Scan (18F-Fluciclovine PET-CT) for the Measurement of Therapeutic Response in Patients With Metastatic Prostate Cancer
- Conditions
- Metastatic Prostate CarcinomaStage IVB Prostate Cancer AJCC v8
- Interventions
- First Posted Date
- 2019-10-22
- Last Posted Date
- 2025-01-16
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 2
- Registration Number
- NCT04134208
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Evaluation of 18F-fluciclovine (FACBC) PET/MR Uptake in Participants With Glioma
- First Posted Date
- 2019-10-03
- Last Posted Date
- 2022-12-06
- Lead Sponsor
- James Mountz
- Target Recruit Count
- 9
- Registration Number
- NCT04114370
- Locations
- 🇺🇸
UPMC Hospitals, Pittsburgh, Pennsylvania, United States
18Fluorine-Fluciclovine PET/CT for Staging Muscle Invasive Bladder Cancer Preceding Radical Cystectomy
- Conditions
- Urothelial CarcinomaBladder Cancer
- Interventions
- Device: PET/CT
- First Posted Date
- 2019-07-12
- Last Posted Date
- 2025-02-05
- Lead Sponsor
- Brigham and Women's Hospital
- Target Recruit Count
- 16
- Registration Number
- NCT04018053
- Locations
- 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.