MRI-PET

  • Research type

    Research Study

  • Full title

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

  • IRAS ID

    117445

  • Contact name

    Manit Arya

  • Contact email

    orchidtrials@qmcr.qmul.ac.uk

  • Sponsor organisation

    Queen Mary University of London

  • Research summary

    The presence of metastatic disease in the lymph nodes of the groin is the most important factor in predicting the likely outcome for patients 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 spread to the lymph nodes. In these patients, Dynamic Sentinel Lymph Node Biopsy (DSLB) is required to determine if the cancer has spread to the lymph nodes. DSLB 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 metastatic disease. In order to confirm if metastatic disease is present in the lymph nodes of these patients a biopsy is required using an ultrasound scan to detect the lymph nodes.

    MRI-PET is a new procedure which combines conventional MRI (Magnetic Resonance Imaging) and PET (Positron Emission Tomography) scans into one scan. 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.

    This single centre, diagnostic study will recruit up to 107 patients (52 clinically node negative and 55 clinically node positive men) with squamous cell carcinoma of the penis.

  • REC name

    London - City & East Research Ethics Committee

  • REC reference

    13/LO/0530

  • Date of REC Opinion

    24 Jun 2013

  • REC opinion

    Further Information Favourable Opinion