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 currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Barts & The London NHS Trust
Sponsor:
Collaborators:
Barts Cancer Institute, London, UK
Birmingham Woman’s Hospital, West Midlands, UK
Case Western Reserve University
Guy's Hospital, London, UK
Hammersmith Hospital, London, UK
Memorial Sloan-Kettering Cancer Center, USA
Queen Elizabeth Hospital, Gateshead, UK
Royal Preston Hospital, Lancashire, UK
Royal Marsden NHS Foundation Trust, Sutton, UK
University of Birmingham, West Midlands, UK
Information provided by (Responsible Party):
Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT01836484
First received: January 31, 2013
Last updated: April 17, 2013
Last verified: April 2013
  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
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

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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Nodal Coverage planning: standard radiotherapy planning vrs DW-MRI [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Histopathological findings vrs functional imaging findings [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Lymph node tissue samples


Estimated Enrollment: 150
Study Start Date: October 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Surgically staged endometrial and cervical carcinoma

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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01836484

Contacts
Contact: Sofia Fernandes, MSc 0044(0)2078828487 MAPPING@qmcr.qmul.ac.uk
Contact: Helen Evans, PhD 0044(0)2078828490 Helen.Evans@qmul.ac.uk

Locations
United Kingdom
Birmingham City Hospital, Sandwell & West Birmingham Hospitals NHS Trust Not yet recruiting
Birmingham, United Kingdom, B18 7QH
Contact: Sudha Sundar, Mrs       sudha.sundar@nhs.net   
Queen Elizabeth Hospital, Birmingham University Hospitals, Birmingham NHS Foundation Trust Not yet recruiting
Birmingham, United Kingdom, B15 2TH
Contact: Peter Guest, Dr       Peter.Guest@uhb.nhs.uk   
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust Recruiting
Cambridge, United Kingdom, CB2 0QQ
Contact: Susan Freeman, Dr    0044(0)1223 245 151 2533    sue.freeman@addenbrookes.nhs.uk   
Hammersmith Hospital, Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom, W12 0HS
Contact: Nishat Bharwani, Dr       Nishat.Bharwani@imperial.nhs.uk   
St Bartholomew's Hospital, Barts Health NHS Trust Recruiting
London, United Kingdom, EC1A 7BE
Contact: Arjun Jeyarajah, Mr    0044(0)20 3465 5040    A.Jeyarajah@bartsandthelondon.nhs.uk   
Queen Elizabeth Hospital, Gateshead Health NHS Foundation Trust Not yet recruiting
Newcastle, United Kingdom, NE9 6SX
Contact: Richard Edmondson, Professor       richard.edmondson@newcastle.ac.uk   
Royal Preston Hospital, Lancashire Teaching Hospitals NHS Foundation Trust Recruiting
Preston, United Kingdom, PR2 9HT
Contact: Jonathan Hill, Professor    0044(0)1772 522734    jonathan.hill@lthtr.nhs.uk   
The Royal Marsden, The Royal Marsden NHS Foundation Trust Not yet recruiting
Sutton, United Kingdom, SM2 5PT
Contact: Aslam Sohaib, Dr       Aslam.Sohaib@rmh.nhs.uk   
Sponsors and Collaborators
Barts & The London NHS Trust
Barts Cancer Institute, London, UK
Birmingham Woman’s Hospital, West Midlands, UK
Case Western Reserve University
Guy's Hospital, London, UK
Hammersmith Hospital, London, UK
Memorial Sloan-Kettering Cancer Center, USA
Queen Elizabeth Hospital, Gateshead, UK
Royal Preston Hospital, Lancashire, UK
Royal Marsden NHS Foundation Trust, Sutton, UK
University of Birmingham, West Midlands, UK
Investigators
Principal Investigator: Andrea Rockall, Professor Hammersmith Hospital - Imperial College Healthcare NHS Trust
  More Information

Additional Information:
No publications provided

Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT01836484     History of Changes
Other Study ID Numbers: 007697
Study First Received: January 31, 2013
Last Updated: April 17, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Carcinoma
Endometrial Neoplasms
Uterine Cervical Neoplasms
Neoplasm Metastasis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Uterine Cervical Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014