Surgically Staged Endometrial and Cervical CarcinomaMAPPINGNCT01836484
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
An observational study of Surgically Staged Endometrial and Cervical Carcinoma and Cervical Cancer: Invasive Disease, FIGO Stage 1B1 or Higher, run by Barts & The London NHS Trust at 7 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Surgically Staged Endometrial and Cervical Carcinoma, Cervical Cancer: Invasive Disease, FIGO Stage 1B1 or Higher, Endometrial Cancer
- What is being tested?
- Diffusion-weighted MRI, Fluorodeoxyglucose-18-PET/CT and Fluoro-ethyl-coline-PET/CT
- How many people
- 162 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- Jun 2012to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 150 women with histologically confirmed endometrial or cervical carcinoma.
Who may be able to join
- Females 18 years or older; (no upper limit).
- Patients with histologically confirmed cancer of the cervix or endometrium.
- 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;
- 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
- 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.
- No contra-indication to FDG-PET/CT, FEC-PET/CT or MRI.
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- 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.
- Able and willing to give written informed consent and to comply with the study protocol procedures
Who cannot join
- Known contra-indication to MRI or PET/CT scan.
- Known allergy to FDG or FEC.
- Not considered fit for lymphadenectomy (open or laparoscopic) or, where appropriate, radiotherapy, as determined by the local MDT.
- If the patient is pregnant or breast-feeding.
- 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
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- Females of childbearing potential must have a negative pregnancy test within three weeks prior to being registered for the study.
- 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.
- Participation in another clinical trial (CTIMP or non-CTIMP) where the protocol contains imaging procedures that would occur during the MAPPING study.
- Medical or psychiatric illness, which makes the patient unsuitable or unable to give informed consent.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
Queen Elizabeth Hospital, Birmingham University Hospitals, Birmingham NHS Foundation Trust
Birmingham, B15 2TH
Birmingham City Hospital, Sandwell & West Birmingham Hospitals NHS Trust
Birmingham, B18 7QH
St Bartholomew's Hospital, Barts Health NHS Trust
London, EC1A 7BE
University College London Hospital
London, NW1 2BU
Hammersmith Hospital, Imperial College Healthcare NHS Trust
London, W12 0HS
Royal Preston Hospital, Lancashire Teaching Hospitals NHS Foundation Trust
Preston, PR2 9HT
The Royal Marsden, The Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT
About this study
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
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.
Read the 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.
- Conditions
- Surgically Staged Endometrial and Cervical Carcinoma, Cervical Cancer: Invasive Disease, FIGO Stage 1B1 or Higher, Endometrial Cancer, Stage 1A With Myometrial Invasion or Any Higher Stage and Grade 3, Stage 1A With Myometrial Invasion or Any Other Higher Stage and Serous Papillary or Clear Cell Sub-types, Stage II Disease or Above and Any Histology Grade
- Being tested
- Diffusion-weighted MRI, Fluorodeoxyglucose-18-PET/CT, Fluoro-ethyl-coline-PET/CT
- Keywords
- Surgically staged endometrial carcinoma, Surgically staged cervical carcinoma
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Lymphoma, Follicular, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion-weighted MRIDiagnostic test
Also called DW-MRI
Fluorodeoxyglucose-18-PET/CTDiagnostic test
Also called FDG-PET/CT
Fluoro-ethyl-coline-PET/CTDiagnostic test
Also called FEC-PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Surgically staged endometrial and cervical carcinoma | Not described Receives: Diagnostic Test: Diffusion-weighted MRI; Diagnostic Test: Fluorodeoxyglucose-18-PET/CT; Diagnostic Test: Fluoro-ethyl-coline-PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate (DR) vrs false positive rate (FPR) for each of the diagnostic modalities.
Measured: 36 months
Secondary outcomes (3)
Detection rate (DR) vrs false positive rate (FPR) between each of the diagnostic modalities and within different histological sub-sets.
Measured: 36 months
Nodal Coverage planning: standard radiotherapy planning vrs DW-MRI
Measured: 36 months
Histopathological findings vrs functional imaging findings
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2013 (estimated)
- Study startJun 2012
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgically Staged Endometrial and Cervical CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Birmingham Women's NHS Foundation Trust, Case Western Reserve University, Guy's and St Thomas' NHS Foundation Trust, Hammersmith Hospitals NHS Trust, Memorial Sloan Kettering Cancer Center, Queen Elizabeth Hospital, Gateshead, UK, Royal Preston Hospital, Lancashire, UK, Royal Marsden NHS Foundation Trust, University of Birmingham
- Responsible party
- Sponsor
- Investigators
- Andrea Rockall, Professor, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836484
- Sponsor's protocol ID
- 007697
- Acronym
- MAPPING
- Status last verified
- Feb 2020
- First submitted
- 31 Jan 2013
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01836484
- Acronym / sponsor ID
- MAPPING / 007697
- Conditions
- Surgically Staged Endometrial and Cervical Carcinoma, Cervical Cancer: Invasive Disease, FIGO Stage 1B1 or Higher, Endometrial Cancer, Stage 1A With Myometrial Invasion or Any Higher Stage and Grade 3, Stage 1A With Myometrial Invasion or Any Other Higher Stage and Serous Papillary or Clear Cell Sub-types, Stage II Disease or Above and Any Histology Grade
- Keywords
- Surgically staged endometrial carcinoma, Surgically staged cervical carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- Birmingham Women's NHS Foundation Trust, Case Western Reserve University, Guy's and St Thomas' NHS Foundation Trust, Hammersmith Hospitals NHS Trust, Memorial Sloan Kettering Cancer Center, Queen Elizabeth Hospital, Gateshead, UK, Royal Preston Hospital, Lancashire, UK, Royal Marsden NHS Foundation Trust, University of Birmingham
- Study start
- Jun 2012 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 22 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgically staged endometrial and cervical carcinoma | – | Diagnostic Test: Diffusion-weighted MRI, Diagnostic Test: Fluorodeoxyglucose-18-PET/CT, Diagnostic Test: Fluoro-ethyl-coline-PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 150 women with histologically confirmed endometrial or cervical carcinoma.
Key inclusion criteria (9 listed)
- Females 18 years or older; (no upper limit).
- Patients with histologically confirmed cancer of the cervix or endometrium.
- No contra-indication to FDG-PET/CT, FEC-PET/CT or MRI.
- 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.
Key exclusion criteria (10 listed)
- Known contra-indication to MRI or PET/CT scan.
- Known allergy to FDG or FEC.
- Not considered fit for lymphadenectomy (open or laparoscopic) or, where appropriate, radiotherapy, as determined by the local MDT.
- If the patient is pregnant or breast-feeding.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diffusion-weighted MRIAlso: DW-MRI | Diagnostic test | Surgically staged endometrial and cervical carcinoma |
| Fluorodeoxyglucose-18-PET/CTAlso: FDG-PET/CT | Diagnostic test | Surgically staged endometrial and cervical carcinoma |
| Fluoro-ethyl-coline-PET/CTAlso: FEC-PET/CT | Diagnostic test | Surgically staged endometrial and cervical carcinoma |
Primary outcome
Detection rate (DR) vrs false positive rate (FPR) for each of the diagnostic modalities.
Time frame: 36 months
3 secondary outcomes
Detection rate (DR) vrs false positive rate (FPR) between each of the diagnostic modalities and within different histological sub-sets.
Time frame: 36 months
Nodal Coverage planning: standard radiotherapy planning vrs DW-MRI
Time frame: 36 months
Histopathological findings vrs functional imaging findings
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Rockall, Professor principal investigator
Imperial College Healthcare NHS Trust
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgically Staged Endometrial and Cervical Carcinoma and Cervical Cancer: Invasive Disease, FIGO Stage 1B1 or Higher, run by Barts & The London NHS Trust at 7 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate (DR) vrs false positive rate (FPR) for each of the diagnostic modalities. (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.