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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)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01836484
First Posted: April 22, 2013
Last Update Posted: August 31, 2017
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.
Collaborators:
Birmingham Women's NHS Foundation Trust
Case Western Reserve University
Guy's Hospital, London, UK
Hammersmith Hospitals NHS Trust
Memorial Sloan-Kettering Cancer Center, USA
Queen Elizabeth Hospital, Gateshead, UK
Royal Preston Hospital, Lancashire, UK
Royal Marsden NHS Foundation Trust
University of Birmingham
Information provided by (Responsible Party):
Barts & The London NHS Trust
  Purpose
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.

Condition Intervention
Surgically Staged Endometrial and Cervical Carcinoma Cervical Cancer: Invasive Disease, FIGO Stage 1B1 or Higher Endometrial Cancer Stage 1A With Myometrial Invasion or Any Higher Stage and Grade 3 Stage 1A With Myometrial Invasion or Any Other Higher Stage and Serous Papillary or Clear Cell Sub-types Stage II Disease or Above and Any Histology Grade Diagnostic Test: Diffusion-weighted MRI Diagnostic Test: Fluorodeoxyglucose-18-PET/CT Diagnostic Test: Fluoro-ethyl-coline-PET/CT

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: 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

Further study details as provided by Barts & The London NHS Trust:

Primary Outcome Measures:
  • Detection rate (DR) vrs false positive rate (FPR) for each of the diagnostic modalities. [ Time Frame: 36 months ]

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

Biospecimen Retention:   Samples With DNA
Lymph node tissue samples

Estimated Enrollment: 150
Study Start Date: October 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Surgically staged endometrial and cervical carcinoma Diagnostic Test: Diffusion-weighted MRI
Other Name: DW-MRI
Diagnostic Test: Fluorodeoxyglucose-18-PET/CT
Other Name: FDG-PET/CT
Diagnostic Test: Fluoro-ethyl-coline-PET/CT
Other Name: FEC-PET/CT

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
150 women with histologically confirmed endometrial or cervical carcinoma.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836484


Locations
United Kingdom
Queen Elizabeth Hospital, Birmingham University Hospitals, Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B15 2TH
Birmingham City Hospital, Sandwell & West Birmingham Hospitals NHS Trust
Birmingham, United Kingdom, B18 7QH
St Bartholomew's Hospital, Barts Health NHS Trust
London, United Kingdom, EC1A 7BE
University College London Hospital
London, United Kingdom, NW1 2BU
Hammersmith Hospital, Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0HS
Royal Preston Hospital, Lancashire Teaching Hospitals NHS Foundation Trust
Preston, United Kingdom, PR2 9HT
The Royal Marsden, The Royal Marsden NHS Foundation Trust
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Barts & The London NHS Trust
Birmingham Women's NHS Foundation Trust
Case Western Reserve University
Guy's Hospital, London, UK
Hammersmith Hospitals NHS Trust
Memorial Sloan-Kettering Cancer Center, USA
Queen Elizabeth Hospital, Gateshead, UK
Royal Preston Hospital, Lancashire, UK
Royal Marsden NHS Foundation Trust
University of Birmingham
Investigators
Principal Investigator: Andrea Rockall, Professor Barts & The London NHS Trust
  More Information

Additional Information:
Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT01836484     History of Changes
Other Study ID Numbers: 007697
First Submitted: January 31, 2013
First Posted: April 22, 2013
Last Update Posted: August 31, 2017
Last Verified: August 2017

Keywords provided by Barts & The London NHS Trust:
Surgically staged endometrial carcinoma
Surgically staged cervical carcinoma

Additional relevant MeSH terms:
Carcinoma
Uterine Cervical Neoplasms
Endometrial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action