This study is NOT currently recruiting participants.
Number
001750-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Recruitment has not started Gender: Male Min Age: 18 Years Max Age: 120 Years
Referral Letter Required
No
Population Exclusion(s)
Children;Female
Keywords
Risk Map Decision Support Systems Tool; Artificial Intelligence; Magnetic Resonance Imaging Interpretation; Magnetic Resonance Imaging Guided Biopsy
Recruitment Keyword(s)
None
Condition(s)
Prostate Cancer; Prostate Adenocarcinoma; Prostate Neoplasm
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Other: Risk Map Decision Support Systems (DSS) Tool Radiation: MRI Procedure/Surgery: Magnetic Resonance Imaging (MRI) Guided Biopsy
Supporting Site
National Cancer Institute
Prostate cancer is the most frequently diagnosed cancer in US men. It is also the second most common cause of cancer death in US men. Doctors use magnetic resonance imaging (MRI) scans to look for tumors within the prostate. These sites are then targeted for removal of tissue samples (biopsy). Biopsies sample only 1 percent of the prostate; the cancer is often missed. Risk Map Decision Support System (DSS) is a new tool that uses artificial intelligence to analyze MRI images. Risk Map DSS may be able to find prostate tumors missed by standard MRI.
Objective:
To see if Risk Map DSS is better than standard MRI at finding targets for prostate biopsy.
Eligibility:
People aged 18 years and older with prostate cancer. They must be scheduled to have (1) an MRI scan and (2) an MRI-guided fusion biopsy as part of their standard care.
Design:
Participants medical records will be reviewed. This review will include existing images and lab results.
Participants will have an MRI ordered by their own doctor. They will remain in the scanner for 15 additional minutes to collect data for the Risk Map DSS.
Participants will have an MRI-guided fusion biopsy ordered by their own doctor. A fusion biopsy uses imaging scans to help target sites for collecting tissue samples. Up to 2 extra sites may be biopsied based on targets selected by the Risk Map DSS.
Participants will be monitored for 1 year after biopsy.
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INCLUSION CRITERIA -Patients with known or suspected PCa who have been referred for a diagnostic MRI exam of the prostate, to be followed by an MRI-guided fusion biopsy of the prostate. -Voluntary written informed consent before the MRI examination. EXCLUSION CRITERIA -Subjects incapable of giving informed written consent. -Subjects who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher; -Subjects with psychiatric disorders that affect their ability to consent for themselves will be excluded and not the entire population of patients with psychiatric disorders. -Prisoners. -Minor children (under the age of 18 years old). -Patients with previous treatments (surgery, radiation, focal ablation, hormone or other chemotherapy) for PCa.
-Patients with known or suspected PCa who have been referred for a diagnostic MRI exam of the prostate, to be followed by an MRI-guided fusion biopsy of the prostate.
-Voluntary written informed consent before the MRI examination.
EXCLUSION CRITERIA
-Subjects incapable of giving informed written consent.
-Subjects who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher;
-Subjects with psychiatric disorders that affect their ability to consent for themselves will be excluded and not the entire population of patients with psychiatric disorders.
-Prisoners.
-Minor children (under the age of 18 years old).
-Patients with previous treatments (surgery, radiation, focal ablation, hormone or other chemotherapy) for PCa.
Principal Investigator
Referral Contact
For more information: