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
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
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
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
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