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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Queen Mary University of London
Sponsor:
Information provided by (Responsible Party):
Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT02104063
First received: November 18, 2013
Last updated: April 1, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Squamous Cell Carcinoma of the Penis
Procedure: MRI-PET
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterising Metastatic Penile Cancer Using Molecular Imaging - Hybrid MRI-PET [MRI-PET]

Resource links provided by NLM:


Further study details as provided by Queen Mary University of London:

Primary Outcome Measures:
  • Evaluating the clinical validity (sensitivity, specificity, negative and positive predictive values) of whole-body MRI-PET to detect or exclude micrometastatic disease in inguinal lymph nodes. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Evaluating the clinical validity (sensitivity, specificity, negative and positive predictive values) of whole-body MRI-PET imaging to detect or exclude micrometastatic disease in inguinal lymph nodes in patients diagnosed with squamous cell carcinoma of the penis using dynamic sentinel lymph node biopsy as the reference standard for clinically impalpable inguinal lymph nodes and ultrasound guided fine needle aspiration/ excisional biopsy as the reference standard in patients with clinically palpable inguinal lymph nodes.


Biospecimen Retention:   Samples Without DNA

Whole blood, serum, biopsy tissue of primary penile cancer lesions and metastatic lesions.


Estimated Enrollment: 107
Study Start Date: October 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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.

Detailed Description:

Penile cancer is a neglected area in terms of clinical and molecular research due to the relatively low incidence of the disease (age standardized incidence is 0.3 - 1 per 100,000 men in European countries and the USA). Inguinal nodes are impalpable in up to 80% of penile cancer patients on presentation. However, 20% of these will harbour occult metastases. Therefore radical inguinal lymphadenectomy, with its significant associated morbidity of up to 70% (and mortality), is an unnecessary surgical procedure in the majority of patients. There are presently only limited data available from small series pertaining to the role of radiological imaging modalities establishing the presence of lymph node metastases, particularly micrometastases, in patients with squamous cell carcinoma of the penis. Thus there is no clear role at the moment for radiological investigations in staging men with impalpable inguinal lymph nodes at presentation. Dynamic sentinel lymph node biopsy is an invasive procedure which utilizes lymphoscintigraphy but still requires surgical excision of the lymph nodes.

Simultaneous PET and MRI using new hybrid MRI-PET systems promises optimal spatial and temporal co-registration of structural, functional, and molecular image data. The theoretical advantages of hybrid MRI-PET scanning compared to CT-PET are better soft tissue resolution, which is advantageous for the small lymph nodes, and also decreased radiation exposure. Also, local staging of the primary penile tumour could be performed simultaneously with the inguinal lymph nodes using MRI-PET. If effective, MRI-PET would provide a single non-invasive imaging test that would replace dynamic sentinel lymph node biopsy (which is operator dependent, involves a general anaesthetic, in-patient hospital stay and has associated morbidity) in the detection of micrometastatic deposits in those patients with cN0 (impalpable inguinal lymph nodes) disease. In addition to this, a single MRI-PET sequence will also stage the primary lesion.

University College London Hospital (UCLH) manages the largest number of penile cancer patients in the United Kingdom (UK). Hybrid MRI-PET is a new imaging modality which could result in significant cost savings, and more importantly, avoid invasive operative procedures necessitating in-patient hospital stay (with the associated potential for significant morbidity). UCLH currently has the only hybrid MRI-PET scanner in the UK. This research is unique and groundbreaking and could have a dramatic impact for penile cancer patients. Additionally, as serum, blood and frozen tissue from this cohort of patients will be collected and stored , this will provide an extremely valuable resource for future translational studies.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients referred to UCLH presenting with penile cancer will be approached for consideration of inclusion into the study.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02104063

Contacts
Contact: Manit Arya, MBChB FRCS orchidtrials@qmcr.qmul.ac.uk

Locations
United Kingdom
University College London Hospitals Recruiting
London, United Kingdom, NW1 2BU
Contact: Manit Arya, MBChB, FRCS       orchidtrials@qmcr.qmul.ac.uk   
Sponsors and Collaborators
Queen Mary University of London
Investigators
Principal Investigator: Manit Arya, MBChB, FRCS University College London Hospitals
  More Information

Publications:

Responsible Party: Queen Mary University of London
ClinicalTrials.gov Identifier: NCT02104063     History of Changes
Other Study ID Numbers: 008956QM
Study First Received: November 18, 2013
Last Updated: April 1, 2014
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Additional relevant MeSH terms:
Penile Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Penile Diseases

ClinicalTrials.gov processed this record on August 28, 2014