NCT05447273 The Role of Functional Magnetic Resonance Imaging in Preoperative Assessment of Primary Penile Carcinoma
| NCT ID | NCT05447273 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oslo University Hospital |
| Condition | Penile Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-07-15 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2022-07-15 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * newly diagnosed penile squamous cell carcinoma (SCC) * the patient will benefit from organ-sparing surgery (OSS) * signed broad consent for cancer research Exclusion Criteria: * N/A
Contact & Investigator
Marta D Switlyk, MD PhD
PRINCIPAL INVESTIGATOR
Oslo University Hospital
Frequently Asked Questions
Who can join the NCT05447273 clinical trial?
This trial is open to male participants only, studying Penile Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05447273 currently recruiting?
Yes, NCT05447273 is actively recruiting participants. Contact the research team at marswi@ous-hf.no for enrollment information.
Where is the NCT05447273 trial being conducted?
This trial is being conducted at Oslo, Norway.
Who is sponsoring the NCT05447273 clinical trial?
NCT05447273 is sponsored by Oslo University Hospital. The principal investigator is Marta D Switlyk, MD PhD at Oslo University Hospital. The trial plans to enroll 60 participants.
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