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

NCT05447273 | Recruiting

• 1 other identifier: 428797
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Penile Cancer

Outcome Measures

Primary Outcomes (1)

• Functional imaging

  Assess tumor extent and infiltration depth on multi-parametric MRI (mrT-stage) with histopathological evaluation as a reference standard. Explore usefulness of multi-parametric MRI in assessing inguinal and pelvic lymph nodes (mrN-stage). 2-fluoro-2-deoxy-D-glucose positron emission tomography/computed tomography (FDG PET-CT), sentinel lymph node evaluation and histopathological examination of the resected specimen will be a gold standard.

  2022-2024

Secondary Outcomes (2)

• Clinical outcome

  2022-2030

• Functional outcome

  2022-2030

Study Arms (1)

Patients with penile squamous cell carcinoma.

Patients with penile squamous cell carcinoma.

Diagnostic Test: Multi-parametric, functional magnetic resonance imaging (MRI)

Interventions

Multi-parametric, functional magnetic resonance imaging (MRI) DIAGNOSTIC_TEST

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

Patients with penile squamous cell carcinoma.

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with newly diagnosed penile squamous cell carcinoma (SCC), referred to surgical treatment.

You may qualify if:

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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, Norway

RECRUITING

Related Publications (10)

• Hanchanale V, Yeo L, Subedi N, Smith J, Wah T, Harnden P, Bhattarai S, Chilka S, Eardley I. The accuracy of magnetic resonance imaging (MRI) in predicting the invasion of the tunica albuginea and the urethra during the primary staging of penile cancer. BJU Int. 2016 Mar;117(3):439-43. doi: 10.1111/bju.13041. Epub 2015 Jun 3.

  PMID: 25600638 BACKGROUND

• Cubilla AL, Barreto J, Caballero C, Ayala G, Riveros M. Pathologic features of epidermoid carcinoma of the penis. A prospective study of 66 cases. Am J Surg Pathol. 1993 Aug;17(8):753-63. doi: 10.1097/00000478-199308000-00001.

  PMID: 8338190 BACKGROUND

• Kayes O, Minhas S, Allen C, Hare C, Freeman A, Ralph D. The role of magnetic resonance imaging in the local staging of penile cancer. Eur Urol. 2007 May;51(5):1313-8; discussion 1318-9. doi: 10.1016/j.eururo.2006.11.014. Epub 2006 Nov 13.

  PMID: 17113213 BACKGROUND

• Philippou P, Shabbir M, Malone P, Nigam R, Muneer A, Ralph DJ, Minhas S. Conservative surgery for squamous cell carcinoma of the penis: resection margins and long-term oncological control. J Urol. 2012 Sep;188(3):803-8. doi: 10.1016/j.juro.2012.05.012. Epub 2012 Jul 19.

  PMID: 22818137 BACKGROUND

• Kieffer JM, Djajadiningrat RS, van Muilekom EA, Graafland NM, Horenblas S, Aaronson NK. Quality of life for patients treated for penile cancer. J Urol. 2014 Oct;192(4):1105-10. doi: 10.1016/j.juro.2014.04.014. Epub 2014 Apr 18.

  PMID: 24747092 BACKGROUND

• Romero FR, Romero KR, Mattos MA, Garcia CR, Fernandes Rde C, Perez MD. Sexual function after partial penectomy for penile cancer. Urology. 2005 Dec;66(6):1292-5. doi: 10.1016/j.urology.2005.06.081.

  PMID: 16360459 BACKGROUND

• Veeratterapillay R, Teo L, Asterling S, Greene D. Oncologic Outcomes of Penile Cancer Treatment at a UK Supraregional Center. Urology. 2015 May;85(5):1097-1103. doi: 10.1016/j.urology.2014.11.048. Epub 2015 Mar 10.

  PMID: 25769781 BACKGROUND

• Petralia G, Villa G, Scardino E, Zoffoli E, Renne G, de Cobelli O, Bellomi M. Local staging of penile cancer using magnetic resonance imaging with pharmacologically induced penile erection. Radiol Med. 2008 Jun;113(4):517-28. doi: 10.1007/s11547-008-0273-6. Epub 2008 May 13. English, Italian.

  PMID: 18478188 BACKGROUND

• Scardino E, Villa G, Bonomo G, Matei DV, Verweij F, Rocco B, Varela R, de Cobelli O. Magnetic resonance imaging combined with artificial erection for local staging of penile cancer. Urology. 2004 Jun;63(6):1158-62. doi: 10.1016/j.urology.2004.01.008.

  PMID: 15183971 BACKGROUND

• Krishna S, Shanbhogue K, Schieda N, Morbeck F, Hadas B, Kulkarni G, McInnes MD, Baroni RH. Role of MRI in Staging of Penile Cancer. J Magn Reson Imaging. 2020 Jun;51(6):1612-1629. doi: 10.1002/jmri.27060. Epub 2020 Jan 24.

  PMID: 31976600 BACKGROUND

MeSH Terms

Conditions

Penile Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Penile Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Marta D Switlyk, MD PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta D Switlyk, MD PhD

CONTACT

47 915 02 770; marswi@ous-hf.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 3, 2022
• First Posted: July 7, 2022
• Study Start: July 15, 2022
• Primary Completion: June 1, 2025
• Study Completion (Estimated): January 1, 2030
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)