Diagnostic accuracy of MRI, diffusion-weighted MRI, FDGPET/CT and Fluoro-ethyl-choline PET/CT in the detection of lymph node metastases in surgically staged endometrial and cervical carcinoma | Not Recruiting
Diagnostic accuracy of MRI, diffusion-weighted MRI, FDGPET/CT and Fluoro-ethyl-choline PET/CT in the detection of lymph node metastases in surgically staged endometrial and cervical carcinoma
MAPPING
Trial Source

Health Conditions
  • Topic: National Cancer Research Network
  • Subtopic: Gynaecological Cancer
  • Disease: Cervix, Endometrium
Not Recruiting
Recruitment Status
ISRCTN84527805
Primary Trial ID Number
Summary
The aim of this trial is to demonstrate whether leading edge imaging technology (DW-MRI, FEC- PET/CT and FDG-PET/CT) can identify lymph node metastases with sufficient accuracy to allow non-invasive lymph node staging or minimally invasive lymph node sampling in the place of surgical lymphadenectomy in patients with endometrial and cervical carcinoma at risk of nodal metastases.
Primary Outcome Measures
  • Comparison of DW-MRI, FDG-PET/CT, FEC-PET/CT with histology; Timepoint(s): Within NHS Cancer Plan for pre-operative care for Cancer Patients
Secondary Outcome Measures
  • 1. To compare the diagnostic accuracy of FDG-PET/CT, DW-MRI and FEC-PET/CT to each other in the preoperative diagnosis of metastases in patients with endometrial and cervical cancer
  • 2. To determine whether one imaging modality performs better than the other in particular sub-groups, such as, particular histological sub-groups
  • 3. To determine whether FEC-PET/CT uptake reflects changes in histologic findings
Research Question
  • The aim of this trial is to demonstrate whether leading edge imaging technology [diffusion- weighted magentic resonance imaging (DW-MRI), F18-fluoroethylcholine (FEC)- PET/CT and 18F-fluorodeoxyglucose (FDG)-Positron emission tomography (PET) / computed tomography (CT)] can identify lymph node metastases with sufficient accuracy to allow non-invasive lymph node staging or minimally invasive lymph node sampling in the place of surgical lymphadenectomy in patients with endometrial and cervical carcinoma at risk of nodal metastases.
Design Type
Sorry, this information is not available
Ethics Approval
Not provided at time of registration
Publications
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Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
Adult
Participant Type
Patient
Trial Sample Size
150
Participant Inclusion Criteria
  • 1. Females older than 18 years; (no upper limit)
  • 2. Patients with histologically confirmed cancer of the cervix or endometrium
  • 2.1. demonstrated clinically and/or on MRI. In patients with advanced disease being considered for chemoradiotherapy treatment, patients may be considered for entry if paraaortic nodal lymphadenectomy is being used to inform radiotherapy planning
  • 2.2. In patients with endometrial cancer, a) stage 1A with myometrial invasion or any higher stage and grade 3 histology with lymphovascular space invasion, b) stage 1A with myometrial invasion or any other higher stage and serous papillary or clear cell subtypes. The MDT decision may be based on the combination of tumour characteristics on histology, clinical and imaging findings.
  • 3. No contraindication to FDGPET/CT, FECPET/ 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
  • 5. Able and willing to give written informed consent and to comply with the study protocol procedures; Target Gender: Female ; Lower Age Limit 18 no age limit or unit specified
Participant Exclusion Criteria
  • 1. Known contraindication 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 breastfeeding
  • 5. Females of childbearing potential must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation
  • 5. 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 prior to being registered for the study
  • 7. Medical or psychiatric illness, which makes the patient unsuitable or unable to give informed consent
Interventions
DW-MRI, DW-MRI; FDG-PET/CT, FDG-PET/CT; FEC-PET/CT, FEC-PET/CT; Study Entry : Registration only
Design Details
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Study Design
Non-randomised; Not Specified
Results Reporting
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Acronym
MAPPING
Scientific Title
Diagnostic accuracy of MRI, diffusion-weighted MRI, FDGPET/CT and Fluoro-ethyl-choline PET/CT in the detection of lymph node metastases in surgically staged endometrial and cervical carcinoma: a non-randomised study
Secondary Trial Identifying Number
10984
Website
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Study Funded By
Cancer Research UK (CRUK) (UK)
Funder Type
Sorry, this information is not available
Study Sponsored By
Barts and The London Trust (UK)
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment

01 Feb 2012

Recruitment End Date

01 Jun 2015

Trial End Date

01 Jun 2015

Date added to Registry

14 Dec 2011

Last Updated

05 Oct 2012