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 (MAPPING)
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| ClinicalTrials.gov Identifier: NCT01836484 |
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Recruitment Status :
Active, not recruiting
First Posted : April 22, 2013
Last Update Posted : August 31, 2017
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Sponsor:
Barts & The London NHS Trust
Collaborators:
Birmingham Women's NHS Foundation Trust
Case Western Reserve University
Guy's Hospital, London, UK
Hammersmith Hospitals NHS Trust
Memorial Sloan-Kettering Cancer Center, USA
Queen Elizabeth Hospital, Gateshead, UK
Royal Preston Hospital, Lancashire, UK
Royal Marsden NHS Foundation Trust
University of Birmingham
Information provided by (Responsible Party):
Barts & The London NHS Trust
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| 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 | Diagnostic Test: Diffusion-weighted MRI Diagnostic Test: Fluorodeoxyglucose-18-PET/CT Diagnostic Test: Fluoro-ethyl-coline-PET/CT |
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 |
| Estimated Enrollment : | 150 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Retrospective |
| 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 |
| Study Start Date : | October 2012 |
| Estimated Primary Completion Date : | August 2017 |
| Estimated Study Completion Date : | August 2017 |
| Group/Cohort | Intervention/treatment |
|---|---|
| Surgically staged endometrial and cervical carcinoma |
Diagnostic Test: Diffusion-weighted MRI
Other Name: DW-MRI Diagnostic Test: Fluorodeoxyglucose-18-PET/CT Other Name: FDG-PET/CT Diagnostic Test: Fluoro-ethyl-coline-PET/CT Other Name: FEC-PET/CT |
Primary Outcome Measures :
- Detection rate (DR) vrs false positive rate (FPR) for each of the diagnostic modalities. [ Time Frame: 36 months ]
Secondary Outcome Measures :
- 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 ]
Biospecimen Retention: Samples With DNA
Lymph node tissue samples
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
150 women with histologically confirmed endometrial or cervical carcinoma.
Criteria
Inclusion Criteria:
- Females 18 years or older; (no upper limit).
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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
Exclusion Criteria:
- 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.
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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
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836484
Locations
| United Kingdom | |
| Queen Elizabeth Hospital, Birmingham University Hospitals, Birmingham NHS Foundation Trust | |
| Birmingham, United Kingdom, B15 2TH | |
| Birmingham City Hospital, Sandwell & West Birmingham Hospitals NHS Trust | |
| Birmingham, United Kingdom, B18 7QH | |
| St Bartholomew's Hospital, Barts Health NHS Trust | |
| London, United Kingdom, EC1A 7BE | |
| University College London Hospital | |
| London, United Kingdom, NW1 2BU | |
| Hammersmith Hospital, Imperial College Healthcare NHS Trust | |
| London, United Kingdom, W12 0HS | |
| Royal Preston Hospital, Lancashire Teaching Hospitals NHS Foundation Trust | |
| Preston, United Kingdom, PR2 9HT | |
| The Royal Marsden, The Royal Marsden NHS Foundation Trust | |
| Sutton, United Kingdom, SM2 5PT | |
Sponsors and Collaborators
Barts & The London NHS Trust
Birmingham Women's NHS Foundation Trust
Case Western Reserve University
Guy's Hospital, London, UK
Hammersmith Hospitals NHS Trust
Memorial Sloan-Kettering Cancer Center, USA
Queen Elizabeth Hospital, Gateshead, UK
Royal Preston Hospital, Lancashire, UK
Royal Marsden NHS Foundation Trust
University of Birmingham
Investigators
| Principal Investigator: | Andrea Rockall, Professor | Barts & The London NHS Trust |
Additional Information:
| Responsible Party: | Barts & The London NHS Trust |
| ClinicalTrials.gov Identifier: | NCT01836484 History of Changes |
| Other Study ID Numbers: |
007697 |
| First Posted: | April 22, 2013 Key Record Dates |
| Last Update Posted: | August 31, 2017 |
| Last Verified: | August 2017 |
Keywords provided by Barts & The London NHS Trust:
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Surgically staged endometrial carcinoma Surgically staged cervical carcinoma |
Additional relevant MeSH terms:
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Carcinoma Uterine Cervical Neoplasms Endometrial Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Uterine Neoplasms Genital Neoplasms, Female |
Urogenital Neoplasms Neoplasms by Site Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Fluorodeoxyglucose F18 Radiopharmaceuticals Molecular Mechanisms of Pharmacological Action |