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

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.

Sex

Male

Minimum age

18 Years

Inclusion Criteria:

* Squamous cell carcinoma of the penis.
* Men aged \>= 18 years.
* Willing and able to give written informed consent prior to study entry.
* Patients must be sterile or agree to use adequate contraception during the study period.

Exclusion Criteria:

* Any co-existing medical condition that in the Investigator's judgement will substantially increase the risk associated with the patient's participation in the study.
* Any known contraindication to MRI such as ferrous metal implants, electrical implants (e.g. cochlear implants, cardiac pacemaker), or history of injury involving metal fragments.
* Any known contraindication to PET scans.
* Any known allergy to FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose).
* Uncontrolled diabetes.
* Inability to comply with the study procedures.
* Medical or psychiatric illness, which makes the patient unsuitable or unable to give informed consent.

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