RecruitingNCT05447273

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


Sponsor

Oslo University Hospital

Enrollment

60 participants

Start Date

Jul 15, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: MALE

Inclusion Criteria3

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

Exclusion Criteria1

  • N/A

Interventions

DIAGNOSTIC_TESTMulti-parametric, functional magnetic resonance imaging (MRI)

Multi-parametric, functional magnetic resonance imaging (MRI) will be performed in all included patients prior to surgery.


Locations(1)

Oslo University Hospital

Oslo, Norway

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05447273


Related Trials