Brief Title
Diagnostic Accuracy of MRI, DWI MRI, FDG-PET/CT and FEC PET/CT in the Detection of Lymph Node Metastases in Surgically Staged Endometrial and Cervical Carcinoma
Official 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
Brief Summary
This is a prospective diagnostic performance study which compares three new imaging methods
with the current standard imaging method for the diagnosis of metastatic lymph nodes.
Detailed Description
The aim is to demonstrate whether leading edge molecular imaging technologies (FDG-PET/CT,
DW-MRI and Fluoro-ethyl-choline (FEC) PET/CT) can identify lymph node metastases with
sufficient accuracy to allow non-invasive lymph node staging in patients with endometrial and
cervical carcinoma.
Study Type
Observational
Primary Outcome
Detection rate (DR) vrs false positive rate (FPR) for each of the diagnostic modalities.
Secondary Outcome
Detection rate (DR) vrs false positive rate (FPR) between each of the diagnostic modalities and within different histological sub-sets.
Condition
Surgically Staged Endometrial and Cervical Carcinoma
Intervention
Diffusion-weighted MRI
Study Arms / Comparison Groups
Surgically staged endometrial and cervical carcinoma
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
162
Start Date
June 2012
Completion Date
December 2018
Primary Completion Date
December 2018
Eligibility Criteria
Inclusion Criteria:
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
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.
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
protocol procedures
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) 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
study.
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
informed consent.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Andrea Rockall, Professor, ,
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT01836484
Organization ID
007697
Responsible Party
Sponsor
Study Sponsor
Barts & The London NHS Trust
Collaborators
Birmingham Women's NHS Foundation Trust
Study Sponsor
Andrea Rockall, Professor, Principal Investigator, Imperial College Healthcare NHS Trust
Verification Date
February 2020