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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
Clinical Trials
Related News

Defining Recurrent Disease With Axumin™

Conditions
Prostate Adenocarcinoma
Prostate Cancer
Interventions
Radiation: Salvage Radiation, Axumin
First Posted Date
2019-06-25
Last Posted Date
2019-06-25
Lead Sponsor
Cancer Center of Irvine
Target Recruit Count
20
Registration Number
NCT03996993
Locations
🇺🇸

Kenneth Tokita, Irvine, California, United States

18F-Fluciclovine PET to Distinguish Tumor Progression From Radiation Necrosis

Early Phase 1
Completed
Conditions
Secondary Malignant Neoplasm of Brain and Cerebral Meninges
Interventions
Device: PET/CT of the brain
First Posted Date
2019-04-29
Last Posted Date
2021-05-05
Lead Sponsor
Case Comprehensive Cancer Center
Target Recruit Count
18
Registration Number
NCT03930173
Locations
🇺🇸

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Fluciclovine F18 or Ga68-PSMA PET/CT to Enhance Prostate Cancer Outcomes

Phase 2
Active, not recruiting
Conditions
Prostate Adenocarcinoma
Interventions
Procedure: Computed Tomography
Radiation: Gallium Ga68-labeled PSMA-11
Procedure: Positron Emission Tomography
First Posted Date
2018-12-04
Last Posted Date
2024-05-17
Lead Sponsor
Emory University
Target Recruit Count
140
Registration Number
NCT03762759
Locations
🇺🇸

Grady Health System, Atlanta, Georgia, United States

🇺🇸

Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States

🇺🇸

Emory Saint Joseph's Hospital, Atlanta, Georgia, United States

Fluciclovine F18 PET/CT Imaging in Assessing Hormone-Naive Men With Prostate Cancer That Has Spread to the Bone

Phase 2
Completed
Conditions
Metastatic Prostate Carcinoma
Prostate Carcinoma Metastatic in the Bone
Stage IV Prostate Cancer
Interventions
Procedure: Computed Tomography
Procedure: Positron Emission Tomography
First Posted Date
2018-10-16
Last Posted Date
2024-11-28
Lead Sponsor
University of Utah
Target Recruit Count
17
Registration Number
NCT03707184
Locations
🇺🇸

Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States

Gallium Ga 68-labeled PSMA-11 PET/CT and Fluciclovine F18 PET/CT in Imaging Participants With Recurrent Prostate Cancer After Surgery

Phase 2
Completed
Conditions
Recurrent Prostate Carcinoma
Interventions
Procedure: Computed Tomography
Other: Laboratory Biomarker Analysis
Procedure: Positron Emission Tomography
First Posted Date
2018-05-03
Last Posted Date
2020-10-14
Lead Sponsor
Jonsson Comprehensive Cancer Center
Target Recruit Count
50
Registration Number
NCT03515577
Locations
🇺🇸

UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States

Role of Axumin PET Scan in Germ Cell Tumor

Active, not recruiting
Conditions
Testicular Cancer
Germ Cell Tumor
Testicular Germ Cell Tumor
Germ Cell Cancer Metastatic
Germ Cell Neoplasm of Retroperitoneum
Germ Cell Tumor, Testicular, Childhood
Testicular Choriocarcinoma
Germ Cell Tumor of Testis
Testicular Diseases
Testis Cancer
Interventions
First Posted Date
2018-02-08
Last Posted Date
2024-10-01
Lead Sponsor
University of Texas Southwestern Medical Center
Target Recruit Count
10
Registration Number
NCT03426865
Locations
🇺🇸

UT Southwestern Medical Center, Dallas, Texas, United States

A Phase II Study to Evaluate Axumin PET/CT for Risk Stratification for Prostate Cancer

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2017-12-14
Last Posted Date
2022-05-25
Lead Sponsor
HALO Diagnostics
Target Recruit Count
20
Registration Number
NCT03373006
Locations
🇺🇸

Desert Medical Imaging, Indian Wells, California, United States

Evaluation of Fluciclovine Uptake in Patients With Cervical, Ovarian Epithelial or Endometrial Cancers.

Phase 4
Conditions
Endometrial Cancer
Cervical Cancer
Ovarian Epithelial Cancer
Interventions
First Posted Date
2017-11-21
Last Posted Date
2020-02-28
Lead Sponsor
Bital Savir-Baruch
Target Recruit Count
30
Registration Number
NCT03349463
Locations
🇺🇸

Loyola University Medical Center, Maywood, Illinois, United States

High Resolution PET-MRI Before Prostate Cancer HIFU

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2017-08-28
Last Posted Date
2021-02-21
Lead Sponsor
Timothy J. Daskivich
Target Recruit Count
21
Registration Number
NCT03263780
Locations
🇺🇸

Cedars-Sinai Medical Center, Los Angeles, California, United States

GE-148-002: A Phase 2, Open-label, Single-Center Study to Assess GE-148 (18F) Injection PET Imaging to Detect Localized Prostate Cancer

Phase 2
Terminated
Conditions
Prostate Cancer
Interventions
First Posted Date
2010-08-06
Last Posted Date
2014-02-14
Lead Sponsor
GE Healthcare
Target Recruit Count
25
Registration Number
NCT01176513
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

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