Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02104063
Recruitment Status : Unknown
Verified January 2015 by Queen Mary University of London.
Recruitment status was:  Recruiting
First Posted : April 4, 2014
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
Queen Mary University of London

Tracking Information
First Submitted Date November 18, 2013
First Posted Date April 4, 2014
Last Update Posted Date October 2, 2017
Actual Study Start Date October 2013
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 1, 2014)
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 ]
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02104063 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Characterising Metastatic Penile Cancer Using Molecular Imaging - Hybrid MRI-PET [MRI-PET]
Official Title Characterising Metastatic Penile Cancer Using Molecular Imaging - Hybrid MRI-PET [MRI-PET]
Brief 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.

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Whole blood, serum, biopsy tissue of primary penile cancer lesions and metastatic lesions.
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.
Condition Squamous Cell Carcinoma of the Penis
Intervention 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.
Study Groups/Cohorts 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.
Intervention: Procedure: MRI-PET
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 1, 2014)
107
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2018
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02104063
Other Study ID Numbers 008956QM
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Queen Mary University of London
Study Sponsor Queen Mary University of London
Collaborators Not Provided
Investigators
Principal Investigator: Manit Arya, MBChB, FRCS University College London Hospitals
PRS Account Queen Mary University of London
Verification Date January 2015