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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)

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ClinicalTrials.gov Identifier: NCT01836484
Recruitment Status : Completed
First Posted : April 22, 2013
Last Update Posted : February 13, 2020
Sponsor:
Collaborators:
Birmingham Women's NHS Foundation Trust
Case Western Reserve University
Guy's and St Thomas' NHS Foundation Trust
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

Study Description
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Brief Summary:
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 or disease Intervention/treatment
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

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 Design
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Study Type : Observational
Actual Enrollment : 162 participants
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
Actual Study Start Date : June 2012
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018
Groups and Cohorts
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Group/Cohort Intervention/treatment
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


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

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

Biospecimen Retention:   Samples With DNA
Lymph node tissue samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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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 and St Thomas' NHS Foundation Trust
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
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Principal Investigator: Andrea Rockall, Professor Imperial College Healthcare NHS Trust
More Information
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Additional Information:

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Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT01836484    
Other Study ID Numbers: 007697
First Posted: April 22, 2013    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Keywords provided by Barts & The London NHS Trust:
Surgically staged endometrial carcinoma
Surgically staged cervical carcinoma
Additional relevant MeSH terms:
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Carcinoma
Endometrial Neoplasms
Lymphatic Metastasis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
 Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action