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

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Topic: National Cancer Research Network
  • Subtopic: Gynaecological Cancer
  • Disease: Cervix, Endometrium
Primary Contact Details
Not Recruiting
Recruitment Status
ISRCTN84527805
Primary Trial ID Number
Summary
http://cancerhelp.cancerresearchuk.org/trials/a-study-comparing-mri-scan-pet-ct-scan-cervical-womb-cancer-mapping
Research Details
  • 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.
Phase
Not Applicable
Study Design
Non-randomised; Not Specified
Study Type
Observational
Intervention

DW-MRI, DW-MRI; FDG-PET/CT, FDG-PET/CT; FEC-PET/CT, FEC-PET/CT; Study Entry : Registration only

Intervention Type
Other
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
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
Planned Sample Size: 150; UK 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
Trial Location(s)
GSK Investigational Site
London
EC1M 6BQ
Trial Contact(s)
Primary Trial Contact
Miss Hanna Nicholas
mapping@qmcr.qmul.ac.uk
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
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
EudraCT Number
2011-001290-78
Funder(s)
  • Cancer Research UK (CRUK) (UK)
Other Study ID Numbers
10984
Sponsor(s)
Barts and The London Trust (UK)
Key Dates

Recruitment Start Date

01 Feb 2012

Recruitment End Date

01 Jun 2015

Trial Start Date

01 Feb 2012

Trial End Date

01 Jun 2015

Date Assigned

14 Dec 2011

Last Updated

05 Oct 2012