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NCT05447273Recruiting

The Role of Functional Magnetic Resonance Imaging in Preoperative Assessment of Primary Penile Carcinoma

Source: ClinicalTrials.gov · Last updated 3 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The proposed project is intended as a prospective study that includes 60 patients with newly diagnosed penile squamous cell carcinoma (SCC) referred to Oslo University Hospital (OUH), Radiumhospitalet, for surgery, primarily organ-sparing surgery (OSS). OSS may improve not only quality of life, but also quality of sexual function. However, there is a potential for increased risk of local recurrence after OSS compared to the amputation of the penis. Appropriate preoperative staging, including multi-parametric magnetic resonance imaging (mpMRI), can substantially improve selection of patients and decrease the recurrence rate after surgery. MpMRI without artificial erection is promising diagnostic tool that is poised to be all-in-one solution for staging and preoperative assessment of primary penile cancer, especially prior to OSS. The method is non-invasive and thus comfortable to perform for most of the patients. Novel MRI techniques are not incorporated into current clinical recommendations, and the potential of new, functional sequences has not been evaluated before. The accuracy of functional, non-erectile mpMRI for detecting and staging of primary penile cancer is not known. Thus, the main purpose of this study is to assess the diagnostic value of this method for preoperative assessment of penile cancer.

Status (registry)
Recruiting
Study type
Observational
Enrollment
60 (estimated)
First submitted
3 Jul 2022
Start date
15 Jul 2022
Primary completion date
30 Jun 2025
Lead sponsor
Oslo University Hospital
NCT number
NCT05447273

What you commit to

  • Study type: Observational
  • Planned participants: 60
  • From 15 Jul 2022 to the primary completion date, 30 Jun 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • N/A

Who the study is looking for

  • newly diagnosed penile squamous cell carcinoma (SCC)
  • the patient will benefit from organ-sparing surgery (OSS)
  • signed broad consent for cancer research

Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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SiteCityCountrySite status
Oslo University Hospital
Coordinator of this site? Confirm its status
OsloNorwayRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.