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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 : Active, not recruiting
First Posted : April 22, 2013
Last Update Posted : August 31, 2017
Sponsor:
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

January 31, 2013
April 22, 2013
August 31, 2017
October 2012
August 2017   (Final data collection date for primary outcome measure)
Detection rate (DR) vrs false positive rate (FPR) for each of the diagnostic modalities. [ Time Frame: 36 months ]
Same as current
Complete list of historical versions of study NCT01836484 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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.
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.
Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:
Lymph node tissue samples
Non-Probability Sample
150 women with histologically confirmed endometrial or cervical carcinoma.
  • 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
    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
Surgically staged endometrial and cervical carcinoma
Interventions:
  • Diagnostic Test: Diffusion-weighted MRI
  • Diagnostic Test: Fluorodeoxyglucose-18-PET/CT
  • Diagnostic Test: Fluoro-ethyl-coline-PET/CT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
Same as current
August 2017
August 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01836484
007697
Yes
Not Provided
Not Provided
Barts & The London NHS Trust
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
Principal Investigator: Andrea Rockall, Professor Barts & The London NHS Trust
Barts & The London NHS Trust
August 2017