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

ISRCTN	ISRCTN84527805
DOI	https://doi.org/10.1186/ISRCTN84527805
EudraCT/CTIS number	2011-001290-78
ClinicalTrials.gov number	NCT01836484
Secondary identifying numbers	10984

Submission date: 25/11/2011
Registration date: 14/12/2011
Last edited: 14/04/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-comparing-mri-scan-pet-ct-scan-cervical-womb-cancer-mapping

Contact information

Miss Hanna Nicholas
Scientific

Old Anatomy Building
Rutland Place
Charterhouse Square
London
EC1M 6BQ
United Kingdom

Email	mapping@qmcr.qmul.ac.uk

Study information

Study design	Non-randomised; Not Specified
Primary study design	Observational
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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
Study acronym	MAPPING
Study objectives	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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Topic: National Cancer Research Network; Subtopic: Gynaecological Cancer; Disease: Cervix, Endometrium
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 measure	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
Overall study start date	01/02/2012
Completion date	01/06/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 150; UK Sample Size: 150
Total final enrolment	147
Key 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
Key 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
Date of first enrolment	01/02/2012
Date of final enrolment	01/06/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Old Anatomy Building

London
EC1M 6BQ
United Kingdom

Sponsor information

Barts and The London Trust (UK)
Hospital/treatment centre

Joint Research Office
24-26 Walden Street
London
E1 2AN
England
United Kingdom

"ROR"	https://ror.org/00b31g692

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Results and Publications

Intention to publish date	30/04/2020
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results		02/01/2021	14/04/2022	No	No

Editorial Notes

29/08/2019: The following changes were made to the trial record:
1. ClinicalTrials.gov number added. No publications found, verifying study status with principal investigator.
2. The intention to publish date was added.
04/08/2017: No publications found, verifying study status with principal investigator.