Actively Recruiting

MALE
NCT05447273

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

Led by Oslo University Hospital · Updated on 2024-04-03

60

Participants Needed

1

Research Sites

389 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly diagnosed penile squamous cell carcinoma (SCC)
  • Patient will benefit from organ-sparing surgery (OSS)
  • Signed broad consent for cancer research
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

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Trial Site Locations

Total: 1 location

1

Oslo University Hospital

Oslo, Norway

Actively Recruiting

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Research Team

M

Marta D Switlyk, MD PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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