Condition category
Cancer
Date applied
25/11/2011
Date assigned
14/12/2011
Last edited
05/10/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Miss Hanna Nicholas

ORCID ID

Contact details

Old Anatomy Building
Rutland Place
Charterhouse Square
London
EC1M 6BQ
United Kingdom
mapping@qmcr.qmul.ac.uk

Additional identifiers

EudraCT number

2011-001290-78

ClinicalTrials.gov number

Protocol/serial number

10984

Study information

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

Acronym

MAPPING

Study hypothesis

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

Not provided at time of registration

Study design

Non-randomised; Not Specified

Primary study design

Observational

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

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

Overall trial start date

01/02/2012

Overall trial end date

01/06/2015

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 150; UK Sample Size: 150

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

Recruitment start date

01/02/2012

Recruitment end date

01/06/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Old Anatomy Building
London
EC1M 6BQ
United Kingdom

Sponsor information

Organisation

Barts and The London Trust (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes