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NCT03496844 Clinical Trial

Fluciclovine-PET/CT for Bone Metastases From Prostate Adenocarcinoma

Prostate Adenocarcinoma Clinical Trial

— BoneMetPETCT  

Official title:
A Pilot Study of F-18 Fluciclovine-PET/CT as A Diagnostic Tool for Bone Metastases in Patients With Hormonal Sensitive and Resistant Prostate Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03496844
Other study ID # 1803340164
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 15, 2018
Est. completion date April 27, 2021

Study information
Verified date August 2022
Source University of Arizona
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Determine diagnostic accuracy of Axumin-PET positive bone lesion by confirmatory bone biopsy.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date April 27, 2021
Est. primary completion date April 27, 2021
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Male 2. Be = 18 years of age 3. Diagnosed with prostate cancer 4. Be willing and able to provide informed consent 5. Be informed of the investigational nature of this study Exclusion Criteria: 1. Having a history of severe claustrophobia 2. Weight exceeding 400lbs

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• F-18 fluciclovine-PET/CT scan
PET/CT imaging with F-18 fluciclovine

Locations
Country Name City State
United States University of Arizona Tucson Arizona

Sponsors (3)
Lead Sponsor Collaborator
University of Arizona Banner University Medical Center, Blue Earth Diagnostics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary True Positive and False Positive Rates of F-18 Fluciclovine-PET/CT Findings Compared to Bone Biopsy True positive and false positive rates of positive findings in the skeleton on F-18 fluciclovine-PET/CT scan compared to gold standard pathology from bone biopsy 1 year
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