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
NCT ID: NCT01836484
Last Updated: 2020-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
162 participants
OBSERVATIONAL
2012-06-30
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Surgically staged endometrial and cervical carcinoma
Diffusion-weighted MRI
Fluorodeoxyglucose-18-PET/CT
Fluoro-ethyl-coline-PET/CT
Interventions
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Diffusion-weighted MRI
Fluorodeoxyglucose-18-PET/CT
Fluoro-ethyl-coline-PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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Birmingham Women's NHS Foundation Trust
OTHER_GOV
Case Western Reserve University
OTHER
Guy's and St Thomas' NHS Foundation Trust
OTHER
Hammersmith Hospitals NHS Trust
OTHER
Memorial Sloan-Kettering Cancer Center, USA
UNKNOWN
Queen Elizabeth Hospital, Gateshead, UK
UNKNOWN
Royal Preston Hospital, Lancashire, UK
UNKNOWN
Royal Marsden NHS Foundation Trust
OTHER
University of Birmingham
OTHER
Barts & The London NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Andrea Rockall, Professor
Role: PRINCIPAL_INVESTIGATOR
Imperial College Healthcare NHS Trust
Locations
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Queen Elizabeth Hospital, Birmingham University Hospitals, Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Birmingham City Hospital, Sandwell & West Birmingham Hospitals NHS Trust
Birmingham, , United Kingdom
St Bartholomew's Hospital, Barts Health NHS Trust
London, , United Kingdom
University College London Hospital
London, , United Kingdom
Hammersmith Hospital, Imperial College Healthcare NHS Trust
London, , United Kingdom
Royal Preston Hospital, Lancashire Teaching Hospitals NHS Foundation Trust
Preston, , United Kingdom
The Royal Marsden, The Royal Marsden NHS Foundation Trust
Sutton, , United Kingdom
Countries
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Other Identifiers
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007697
Identifier Type: -
Identifier Source: org_study_id
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