Endometrial and Cervical Cancer
Conditions
Interventions
Product Name: [18F] Fluorodeoxyglucose
Product Code: V09IX04
Pharmaceutical Form: Solution for injection
Product Name: [18F] Fluoro-ethyl-choline
Sponsors
Barts Health NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Females older than 18 years; (no upper limit). 2. Patients with histologically confirmed cancer of the cervix or endometrium. a. 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; b. 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 mixed mullerian, serous papillary or clear cell sub-types. c. 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. 5. Able and willing to give written informed consent and to comply with the study protocol procedures Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
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; abstinence) from the time consent is signed until 6 weeks after the last PET/CT scan. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In patients with cancer of the womb (endometrial and cervical cancer), the detection of tumour in adjacent lymph glands (nodes) is very important for optimal treatment planning. Currently the standard method used to identify cancerous spread is to surgically remove and examine the nodes under the micrscope in order to identify tumour spread in the nodes. A technique that does not require surgical intervention would be highly desirable. Standard imaging on MRI or CT, in which size criteria are used to identify whether a node is malignant, is inaccurate. This study will evaluate three new imaging techniques that may be used to identify malignant nodes preoperatively: (1) Diffusion Weighted MRI, (2) FDG-PET/CT and (3) FEC-PET/CT. The principal objective is to compare the diagnostic performance of each test (detection and false-positive rates) with that of the standard method (size criteria) with histology as the reference standard. ; Secondary Objective: 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. ; Primary end point(s): Our primary outcome measure is the detection rate (DR) and false positive rate (FPR) for each of the diagnostic modalities. DR is the proportion of women with positive histology who are classified as positive by the diagnostic test. DR is also known as sensitivity. False-positive rate (FPR) is the proportion of women with negative histology classified as positive by the diagnostic test. FPR is also known as 1 minus specificity. ;Timepoint( | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: These endpoints will be evaluated at the end of the study, once all patients have completed the study; Secondary end point(s): The following are secondary endpoints for the MAPPING study: To compare the diagnostic performance of FDG-PET/CT, FEC-PET/CT and DW-MRI to each other in the preoperative diagnosis of metastases in patients with endometrial and cervical cancer using histology as the reference standard To determine whether one imaging modality performs better than the other in particular sub-groups, e.g., cervical versus endometrial cancer, different histological/biological sub-types or in advanced stage disease. To determine whether these leading edge imaging technologies can improve the accuracy of delineation of tumour in planning 3-dimensional radiotherapy target volumes. To determine whether the uptake of FDG, FEC and diffusion characteristics correlate with histopathological markers. | — |
Countries
United Kingdom
Contacts
Public ContactAndrea Rockall, c/o Helen Evans
Queen Mary University of London
Outcome results
None listed