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CLINICAL UTILITY OF AXUMIN PET/MRI IMAGING TWO YEARS FOLLOWING FOCAL CRYO-ABLATION (FCA) OF PROSTATE CANCER
This is a prospective outcomes study assessing quality of life and oncological control at pre-defined time points following FOCAL CRYO-ABLATION (FCA). The investigator's standard of care is to perform an Magentic Resonance Imaging (MRI) and prostate biopsy two years following FCA. The prostate biopsy assesses both the presence of in field and out of field disease. The role of Axumin PET/MRI for detecting disease following FCA has not been previously examined.
The primary hypothesis of this study is that 18F-Fluciclovine PET/MRI imaging at two years following FCA will improve sensitivity for detection of in field recurrence of significant prostate cancer defined as any Gleason pattern 4 disease. The secondary hypothesis of this study is that 18F-Fluciclovine PET/MRI imaging at two years following FCA will improve sensitivity for detection of out of field recurrence of significant prostate cancer .
Age
18 - 100 years
Sex
MALE
Healthy Volunteers
No
NYU Langone Health
New York, New York, United States
Start Date
June 19, 2019
Primary Completion Date
January 7, 2021
Completion Date
January 7, 2021
Last Updated
March 30, 2021
31
ACTUAL participants
Standard of Care MRI
DEVICE
Fluciclovine PET scan added to MRI
OTHER
Lead Sponsor
NYU Langone Health
NCT06842498
NCT04550494
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05691465