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 Applicable

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Gynaecological Cancer; Disease: Cervix, Endometrium; Cancer; Malignant neoplasm of cervix uteri

• Registration Number: ISRCTN84527805
• Lead Sponsor: Barts and The London Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-14
• Study Completion: 2015-06-01
• Last Update Posted: 25 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 147

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
<br> 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<br> 2. To determine whether one imaging modality performs better than the other in particular sub-groups, such as, particular histological sub-groups<br> 3. To determine whether FEC-PET/CT uptake reflects changes in histologic findings<br>