Diagnostic Accuracy of MRI, DWI MRI, FDG-PET/CT and FEC PET/CT in the Detection of Lymph Node Metastases in Surgically Staged Endometrial and Cervical Carcinoma (MAPPING)

February 12, 2020 updated by: Barts & The London NHS Trust

Diagnostic Accuracy of MRI, Diffusion-weighted MRI, FDG-PET/CT and Fluoro-ethyl-choline PET/CT in the Detection of Lymph Node Metastases in Surgically Staged Endometrial and Cervical Carcinoma

This is a prospective diagnostic performance study which compares three new imaging methods with the current standard imaging method for the diagnosis of metastatic lymph nodes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim is to demonstrate whether leading edge molecular imaging technologies (FDG-PET/CT, DW-MRI and Fluoro-ethyl-choline (FEC) PET/CT) can identify lymph node metastases with sufficient accuracy to allow non-invasive lymph node staging in patients with endometrial and cervical carcinoma.

Study Type

Observational

Enrollment (Actual)

162

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital, Birmingham University Hospitals, Birmingham NHS Foundation Trust
      • Birmingham, United Kingdom, B18 7QH
        • Birmingham City Hospital, Sandwell & West Birmingham Hospitals NHS Trust
      • London, United Kingdom, EC1A 7BE
        • St Bartholomew's Hospital, Barts Health NHS Trust
      • London, United Kingdom, NW1 2BU
        • University College London Hospital
      • London, United Kingdom, W12 0HS
        • Hammersmith Hospital, Imperial College Healthcare NHS Trust
      • Preston, United Kingdom, PR2 9HT
        • Royal Preston Hospital, Lancashire Teaching Hospitals NHS Foundation Trust
      • Sutton, United Kingdom, SM2 5PT
        • The Royal Marsden, The Royal Marsden NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

150 women with histologically confirmed endometrial or cervical carcinoma.

Description

Inclusion Criteria:

  1. Females 18 years or older; (no upper limit).

  2. Patients with histologically confirmed cancer of the cervix or endometrium.

    1. In patient with cervix cancer, there must be confirmation of invasive disease; FIGO stage 1B1 or higher FIGO stage demonstrated clinically and/or on MRI. In patients with advanced disease being considered for chemoradiotherapy treatment, patients may be considered for entry if nodal lymphadenectomy is being used to inform radiotherapy planning;
    2. In patients with endometrial cancer, a) stage 1A with myometrial invasion or any higher stage and grade 3 b) stage 1A with myometrial invasion or any other higher stage and serous papillary or clear cell sub-types
    3. stage II disease or above and any histology grade The MDT decision may be based on the combination of tumour characteristics on histology, clinical and imaging findings.
  3. No contra-indication to FDG-PET/CT, FEC-PET/CT or MRI.

  4. Fit for surgical lymphadenectomy, as determined by the local MDT. The patient should also be considered fit for extended field radiotherapy in cases where lymphadenectomy is being undertaken to inform radiotherapy planning.

    The extent of lymph node dissection will be made by the local multidisciplinary team, based on the presence of risk factors for lymph node metastases, according to the protocol. Patients must be considered fit to undergo lymph node dissection.

  5. Able and willing to give written informed consent and to comply with the study protocol procedures

Exclusion Criteria:

  1. Known contra-indication to MRI or PET/CT scan.
  2. Known allergy to FDG or FEC.
  3. Not considered fit for lymphadenectomy (open or laparoscopic) or, where appropriate, radiotherapy, as determined by the local MDT.
  4. If the patient is pregnant or breast-feeding.

  5. Females of childbearing potential must be willing to use an effective method of contraception (hormonal or barrier method of birth control) from the time consent is signed until 6 weeks after the last PET/CT scan unless undergoing hysterectomy.

    Note: subjects are not considered of childbearing potential if they are surgically sterile (they have undergone bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal

  6. Females of childbearing potential must have a negative pregnancy test within three weeks prior to being registered for the study.
  7. Participation in another Clinical Trial of an Investigational Medicinal Product (CTIMP). If patient's have recently completed a CTIMP trial they must have had their last dose(s) of study drug prior to their first imaging procedure on the MAPPING study.
  8. Participation in another clinical trial (CTIMP or non-CTIMP) where the protocol contains imaging procedures that would occur during the MAPPING study.
  9. Medical or psychiatric illness, which makes the patient unsuitable or unable to give informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgically staged endometrial and cervical carcinoma
Diagnostic test: Diffusion-weighted MRI
Other Names:
  • DW-MRI
Diagnostic test: Fluorodeoxyglucose-18-PET/CT
Other Names:
  • FDG-PET/CT
Diagnostic test: Fluoro-ethyl-coline-PET/CT
Other Names:
  • FEC-PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Detection rate (DR) vrs false positive rate (FPR) for each of the diagnostic modalities.
Time Frame: 36 months
36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Detection rate (DR) vrs false positive rate (FPR) between each of the diagnostic modalities and within different histological sub-sets.
Time Frame: 36 months
36 months
Nodal Coverage planning: standard radiotherapy planning vrs DW-MRI
Time Frame: 36 months
36 months
Histopathological findings vrs functional imaging findings
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barts & The London NHS Trust

Collaborators

Royal Marsden NHS Foundation Trust
Guy's and St Thomas' NHS Foundation Trust
Case Western Reserve University
University of Birmingham
Hammersmith Hospitals NHS Trust
Birmingham Women's NHS Foundation Trust
Memorial Sloan-Kettering Cancer Center, USA
Queen Elizabeth Hospital, Gateshead, UK
Royal Preston Hospital, Lancashire, UK

Investigators

  • Principal Investigator: Andrea Rockall, Professor, Imperial College Healthcare NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2012

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

January 31, 2013

First Submitted That Met QC Criteria

April 17, 2013

First Posted (Estimate)

April 22, 2013

Study Record Updates

Last Update Posted (Actual)

February 13, 2020

Last Update Submitted That Met QC Criteria

February 12, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 007697

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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