Addition of Pelvic CT with Agatston Calcium Score for Patients with Peyronie Disease May Change Management Decisions in Patients with Calcified Plaque
Sponsor study identifier
interventional
12
1 country
1
Study Start
August 4, 2022
Actual (reported)Primary Completion
January 17, 2024
Actual (reported)Study Completion
January 17, 2024
Actual (reported)The purpose of this study is to find out how including a CT exam of the penis can help urologists make treatment decisions for patients with calcified Peyronie's disease.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 17, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 25, 2022
Actual (reported)July 29, 2022
Actual (reported)August 4, 2022
Actual (reported)January 17, 2024
Actual (reported)January 17, 2024
Actual (reported)Calcium volume of penile plaques
Peyronie plaques with calcification can be identified with noncontrast CT. The Agatston calcium scoring software is used to mark the calcified plaques to measure the calcium volume (mm3)
Baseline
Calcium score of penile plaques
Peyronie plaques with calcification can be identified with noncontrast CT. The Agatston calcium scoring software is used to mark the calcified plaques to calculate the Agaston calcium score
Baseline
Treatment plans adjustment after CT
Number of treatment plans to be adjusted after CT results. The treatment options for Peyronie's disease are observation, penile traction therapy, oral medication, medication injection, plaque incision, plaque excision, penile plication with graft, penile plication without graft, penile implant with plaque incision and graft, or penile implant with plication. The study urologist plan will be documented before CT results. After CT results the study urologist will or will not adjust the treatment plan.
Within 2 weeks of intervention
Calcified plaque number
Baseline
Calcified plaque length
Baseline
Calcified plaque continuity
Baseline
Subject presenting with Peyronie disease signs or symptoms to Mayo Clinic Florida Department of Urology will undergo a targeted noncontrast CT of the pelvis with specific penile anatomical positioning
Noncontrast CT of the pelvis with specific penile anatomical positioning for coverage and with the protocol optimized for application of Agatston calcium scoring post processing.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
Lauren Alexander, MD
Mayo Clinic
12 participants (actual enrollment reported by the registry).
First Submitted
July 25, 2022
First Posted
July 29, 2022
Study Start
August 4, 2022
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
January 17, 2024
Actual (reported)Study Completion
January 17, 2024
Actual (reported)Last Updated
September 19, 2024
Record last verified: 2024-09
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Source: ClinicalTrials.gov.
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