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Pelvic CT With Agatston Calcium Score for Peyronie Disease

Primary Purpose

Peyronie Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CT exam
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Peyronie Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Peyronie Disease with stable curvature considered for therapeutic intervention
  • PDDU obtained at clinic visit
  • Able to provide informed consent

Exclusion Criteria:

  • Implanted penile prosthesis or implanted urethral sphincter that would prevent adequate CT images
  • Acute active Peyronie disease that would not be managed with injection or surgical therapy

Sites / Locations

  • Mayo Clinic FloridaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Targeted CT of pelvis with specific penile anatomical positioning for Peyronie Disease

Arm Description

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

Outcomes

Primary Outcome Measures

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)
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
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.

Secondary Outcome Measures

Calcified plaque number
Peyronie plaques with calcification can be identified with noncontrast CT and with PDDU. The number of calcified plaques (1, 2, 3 or more than 3) will be counted on CT and PDDU.
Calcified plaque length
Peyronie plaques with calcification can be identified with noncontrast CT and with PDDU. The plaque will be measured in the longest axial and transverse dimensions (mm) on CT and on PDDU.
Calcified plaque continuity
Peyronie plaques with calcification can be identified with noncontrast CT and with PDDU. The plaque will be described as continuous or stippled on CT and PDDU by visual assessment

Full Information

First Posted
July 25, 2022
Last Updated
September 11, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05480683
Brief Title
Pelvic CT With Agatston Calcium Score for Peyronie Disease
Official Title
Addition of Pelvic CT With Agatston Calcium Score for Patients With Peyronie Disease May Change Management Decisions in Patients With Calcified Plaque
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 4, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Peyronie disease (PD) affects up to 10% of men with fibrosing penile plaques causing penile pain and progressing to deformity. Calcified plaque develops in up to 20% of these patients, excluding them from medical therapy with collagenase injection and often requiring more extensive surgery for treatment. PDDU identifies plaque distribution and characteristics while the Doppler exam evaluates for any underlying erectile dysfunction. Calcification can make PDDU difficult to identify the full extent of plaque since the shadow caused by calcification may prevent accurate measurement and over or underestimate the plaque size. In addition, the ultrasound exam is operator dependent and requires injection of an agent to induce erection. Since current clinical practice excludes men with any degree of calcification presumed on physical examination or demonstrated on PDDU from receiving injection therapy they may be triaged to surgical management instead. A prior study found the presence of calcifications at ultrasound had odd ratio 1.75 of patient progressing to surgical management, while fibrosis without calcification did not have increased odds of surgical management. Noncontrast pelvis CT provides three dimensional detail of calcified plaque including parts of the penis that are difficult to image with PDDU, and calcification does not have artifact on CT. By adding non-contrast pelvis CT with Agatston calcium scoring to PDDU and clinical parameters of penile deformity, patients may be better stratified into the appropriate treatment pathway.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peyronie Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Targeted CT of pelvis with specific penile anatomical positioning for Peyronie Disease
Arm Type
Experimental
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
CT exam
Intervention Description
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.
Primary Outcome Measure Information:
Title
Calcium volume of penile plaques
Description
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)
Time Frame
Baseline
Title
Calcium score of penile plaques
Description
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
Time Frame
Baseline
Title
Treatment plans adjustment after CT
Description
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.
Time Frame
Within 2 weeks of intervention
Secondary Outcome Measure Information:
Title
Calcified plaque number
Description
Peyronie plaques with calcification can be identified with noncontrast CT and with PDDU. The number of calcified plaques (1, 2, 3 or more than 3) will be counted on CT and PDDU.
Time Frame
Baseline
Title
Calcified plaque length
Description
Peyronie plaques with calcification can be identified with noncontrast CT and with PDDU. The plaque will be measured in the longest axial and transverse dimensions (mm) on CT and on PDDU.
Time Frame
Baseline
Title
Calcified plaque continuity
Description
Peyronie plaques with calcification can be identified with noncontrast CT and with PDDU. The plaque will be described as continuous or stippled on CT and PDDU by visual assessment
Time Frame
Baseline

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Peyronie Disease with stable curvature considered for therapeutic intervention PDDU obtained at clinic visit Able to provide informed consent Exclusion Criteria: Implanted penile prosthesis or implanted urethral sphincter that would prevent adequate CT images Acute active Peyronie disease that would not be managed with injection or surgical therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Alexander, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kendra Brown, MPH
Phone
904-953-7755
Email
brown.kendra@mayo.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
24119147
Citation
Levine L, Rybak J, Corder C, Farrel MR. Peyronie's disease plaque calcification--prevalence, time to identification, and development of a new grading classification. J Sex Med. 2013 Dec;10(12):3121-8. doi: 10.1111/jsm.12334. Epub 2013 Oct 4.
Results Reference
background
PubMed Identifier
2407762
Citation
Agatston AS, Janowitz WR, Hildner FJ, Zusmer NR, Viamonte M Jr, Detrano R. Quantification of coronary artery calcium using ultrafast computed tomography. J Am Coll Cardiol. 1990 Mar 15;15(4):827-32. doi: 10.1016/0735-1097(90)90282-t.
Results Reference
background
PubMed Identifier
20171694
Citation
Breyer BN, Shindel AW, Huang YC, Eisenberg ML, Weiss DA, Lue TF, Smith JF. Are sonographic characteristics associated with progression to surgery in men with Peyronie's disease? J Urol. 2010 Apr;183(4):1484-8. doi: 10.1016/j.juro.2009.12.026. Epub 2010 Feb 20.
Results Reference
background
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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Pelvic CT With Agatston Calcium Score for Peyronie Disease

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