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Research type
Research Study
Full 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
IRAS ID
72614
Contact name
Andrea Rockall
Contact email
Sponsor organisation
Barts Health NHS Trust
Eudract number
2011-001290-78
ISRCTN Number
ISRCTN84527805
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
In patients with cancer of the womb (endometrial or cervical cancer), the detection of a tumour in adjacent lymph glands is very important to define the extent of disease and for optimal treatment planning. Currently the standard method used to identify cancerous spread is to remove selected lymph nodes and examine them under the microscope for evidence of cancer. It would be highly desirable to have a technique that does not require surgical intervention to detect the cancerous spread and that is accurate in detecting the spread of disease.
This study compares two new available imaging techniques that may be used to find lymph nodes involved with cancer. These scans are:
1. Diffusion Weighted Magnetic Resonance Imaging (DW-MRI)
2. Positron emission tomography - computed tomography (PET/CT)This will be an observational study and an independent assessment will be conducted of the lymph node diagnosis using PET/CT and DW-MRI, comparing it to histology as the gold standard. All observers will be blinded to the results of the other new diagnostic technique and to histology.
We aim to recruit 150 women, each of whom will have the following diagnostic tests:
1. Staging MRI (current standard of care for nodal diagnosis)
2. Diffusion Weighted MRI (this is often part of the standard staging MRI)
3. FDG-PET/CT (this is often included in the staging of patients with cancer of womb)
4. FEC-PET/CT (this will be offered to patients at sites who are able to perform FEC-PET/CT imaging)The outcome measures are:
1. Detection rate – the proportion of women with positive histology who are identified as being positive by DW-MRI, FDG-PET/CT or FEC-PET/CT.
2. False positive rate – the proportion of women with negative histology who are identified as being positive by DW-MRI, FDG-PET/CT or FEC-PET/CT.The detection rate and false positive rate will be compared between the 3 methods against the standard staging MRI with histology as the reference standard.
REC name
London - Fulham Research Ethics Committee
REC reference
11/LO/1465
Date of REC Opinion
30 Nov 2011
REC opinion
Further Information Favourable Opinion