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Characterising Metastatic Penile Cancer Using Molecular Imaging - Hybrid MRI-PET [MRI-PET]

NCT02104063 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 78

Last updated 2025-03-10

No results posted yet for this study

Summary

The presence of metastatic disease in the lymph nodes within the groin is the most important factor in predicting the long-term outcome for patients diagnosed with penile cancer.

In the majority of patients diagnosed with penile cancer obvious abnormalities cannot be felt in the groin even though the cancer may have already spread to the lymph nodes in the groin. In these patients, a procedure called Dynamic Sentinel Lymph Node Biopsy (DSLB) is required to determine if the cancer has spread to the lymph nodes in the groin. In DSLB a radioactive substance is injected at the site of the penile cancer and then travels to the lymph nodes in the groin which are then biopsied. This procedure requires a general anaesthetic and an in-patient hospital stay.

In approximately 20% of patients with penile cancer obvious abnormalities can be felt in the lymph nodes in the groin. However, any abnormality detected may not necessarily be due to metastatic disease. In order to confirm if metastatic disease is present in the lymph nodes of these patients a biopsy is also required. However in these patients the lymph nodes are detected and biopsied using an ultrasound scan rather than by passing a radioactive substance into the body.

MRI-PET is a new procedure which combines conventional MRI (Magnetic Resonance Imaging) and PET (Positron Emission Tomography) scans into one scan. MRI - PET scans create very clear pictures of internal body structures. MRI-PET is a non-invasive procedure which can be performed on an out-patient basis.

The accuracy of MRI-PET in detecting metastatic penile cancer is not known. The main purpose of this study is to establish the effectiveness of MRI-PET compared to DSLB and ultrasound guided biopsy in detecting the presence of metastatic disease in the lymph nodes of patients with penile cancer. If effective, MRI-PET could replace the invasive procedures currently required for detection of metastatic penile cancer.

Conditions

  • Squamous Cell Carcinoma of the Penis

Interventions

PROCEDURE

MRI-PET

Participants will have an MRI-PET scan (the Index test) in addition to the procedures they would normally receive as their standard of care (Reference tests). The accuracy of MRI-PET in detecting or ruling out metastatic penile cancer will be compared to the reference tests.

Sponsors & Collaborators

  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Manit Arya, MBChB, FRCS · University College London Hospitals

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-22
Primary Completion
2016-07-22
Completion
2016-07-22

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02104063 on ClinicalTrials.gov