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Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR FLUCICLOVINE F-18

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Clinical Trials for Fluciclovine F-18

Trial ID Title Status Sponsor Phase Summary
NCT00562315 FACBC PET/CT for Recurrent Prostate Cancer Completed National Cancer Institute (NCI) Phase 2 Hypothesis:Anti-[18F]FACBC PET-CT will adequately detect local and extraprostatic recurrence, and lead to better characterization of disease status in restaging patients. This is a study that will test a compound (chemical substance) that has a small amount of radioactivity attached to it. This substance has a natural tendency to go to prostate tissue. The substance is called [18]FACBC and it is given in the form of an injection into a vein. After the substance reaches the prostate, scans called PET or Positron Emission Tomography, are done. This is similar to having CAT scans or x-rays. Usually a compound called [18]FDG is used for PET scans but this substance is eliminated by the kidneys and cannot reach the prostate. This substance called [18]FACBC is not eliminated by the kidneys and may allow tumors in the prostate to be seen better. It is sometimes difficult to tell if a growth on the prostate is cancer with scans or x-rays that are usually done. Anti-[18F]FACBC PET-CT will be compared to ProstaScint (In-capromab pendetide) which is the conventional imaging for prostate cancer. Investigators will be blinded of the intervention. This study will look at how the [18]FACBC goes into the prostate tissue and determine its ability to detect recurrent prostate cancer.
NCT00562315 FACBC PET/CT for Recurrent Prostate Cancer Completed David M. Schuster, MD Phase 2 Hypothesis:Anti-[18F]FACBC PET-CT will adequately detect local and extraprostatic recurrence, and lead to better characterization of disease status in restaging patients. This is a study that will test a compound (chemical substance) that has a small amount of radioactivity attached to it. This substance has a natural tendency to go to prostate tissue. The substance is called [18]FACBC and it is given in the form of an injection into a vein. After the substance reaches the prostate, scans called PET or Positron Emission Tomography, are done. This is similar to having CAT scans or x-rays. Usually a compound called [18]FDG is used for PET scans but this substance is eliminated by the kidneys and cannot reach the prostate. This substance called [18]FACBC is not eliminated by the kidneys and may allow tumors in the prostate to be seen better. It is sometimes difficult to tell if a growth on the prostate is cancer with scans or x-rays that are usually done. Anti-[18F]FACBC PET-CT will be compared to ProstaScint (In-capromab pendetide) which is the conventional imaging for prostate cancer. Investigators will be blinded of the intervention. This study will look at how the [18]FACBC goes into the prostate tissue and determine its ability to detect recurrent prostate cancer.
NCT02680041 18F Fluciclovine (FACBC) PET/CT in Patients With Rising PSA After Initial Prostate Cancer Treatment Recruiting American College of Radiology Phase 3 This prospective study will enroll up to 330 men with PSA-persistent or PSA-recurrent prostate cancer after curative-intent primary therapy and negative or equivocal findings on standard-of-care imaging. Consenting participants will be imaged with 18F-fluciclovine PET/CT. Site clinicians will manage study subjects per standard practices and will document any change in treatment based on review of 18F-fluciclovine PET/CT findings. All participants will be followed for up to 6 months, with clinical data collected for this study. An interdisciplinary panel will provide expert guidance to local readers on request. The final reporting of the PET/CT scan will be a single report by the local reader following any such discussion.
NCT02680041 18F Fluciclovine (FACBC) PET/CT in Patients With Rising PSA After Initial Prostate Cancer Treatment Recruiting IND 2 Results LLC Phase 3 This prospective study will enroll up to 330 men with PSA-persistent or PSA-recurrent prostate cancer after curative-intent primary therapy and negative or equivocal findings on standard-of-care imaging. Consenting participants will be imaged with 18F-fluciclovine PET/CT. Site clinicians will manage study subjects per standard practices and will document any change in treatment based on review of 18F-fluciclovine PET/CT findings. All participants will be followed for up to 6 months, with clinical data collected for this study. An interdisciplinary panel will provide expert guidance to local readers on request. The final reporting of the PET/CT scan will be a single report by the local reader following any such discussion.
NCT02680041 18F Fluciclovine (FACBC) PET/CT in Patients With Rising PSA After Initial Prostate Cancer Treatment Recruiting Syne Qua Non Limited Phase 3 This prospective study will enroll up to 330 men with PSA-persistent or PSA-recurrent prostate cancer after curative-intent primary therapy and negative or equivocal findings on standard-of-care imaging. Consenting participants will be imaged with 18F-fluciclovine PET/CT. Site clinicians will manage study subjects per standard practices and will document any change in treatment based on review of 18F-fluciclovine PET/CT findings. All participants will be followed for up to 6 months, with clinical data collected for this study. An interdisciplinary panel will provide expert guidance to local readers on request. The final reporting of the PET/CT scan will be a single report by the local reader following any such discussion.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Fluciclovine F-18

Condition Name

Condition Name for Fluciclovine F-18
Intervention Trials
Prostate Cancer 5
Cervical Cancer 2
Recurrent Prostate Carcinoma 1
Cancer 1
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Condition MeSH

Condition MeSH for Fluciclovine F-18
Intervention Trials
Prostatic Neoplasms 7
Endometrial Neoplasms 2
Uterine Cervical Neoplasms 2
Neoplasms, Glandular and Epithelial 1
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Clinical Trial Locations for Fluciclovine F-18

Trials by Country

Trials by Country for Fluciclovine F-18
Location Trials
United States 18
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Trials by US State

Trials by US State for Fluciclovine F-18
Location Trials
California 3
Georgia 3
Utah 2
Pennsylvania 2
Illinois 2
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Clinical Trial Progress for Fluciclovine F-18

Clinical Trial Phase

Clinical Trial Phase for Fluciclovine F-18
Clinical Trial Phase Trials
Phase 4 2
Phase 3 1
Phase 2 6
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Clinical Trial Status

Clinical Trial Status for Fluciclovine F-18
Clinical Trial Phase Trials
Not yet recruiting 5
Recruiting 4
Active, not recruiting 1
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Clinical Trial Sponsors for Fluciclovine F-18

Sponsor Name

Sponsor Name for Fluciclovine F-18
Sponsor Trials
Blue Earth Diagnostics 6
National Cancer Institute (NCI) 3
Emory University 2
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Sponsor Type

Sponsor Type for Fluciclovine F-18
Sponsor Trials
Other 12
Industry 8
NIH 3
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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
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Federal Trade Commission
Covington
Citi
Queensland Health
Express Scripts
Colorcon
Harvard Business School

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