Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Birmingham Women's NHS Foundation Trust | OTHER_GOV |
| Case Western Reserve University | OTHER |
| Guy's and St Thomas' NHS Foundation Trust | OTHER |
| Hammersmith Hospitals NHS Trust |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgically staged endometrial and cervical carcinoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diffusion-weighted MRI | Diagnostic Test |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Detection rate (DR) vrs false positive rate (FPR) for each of the diagnostic modalities. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Detection rate (DR) vrs false positive rate (FPR) between each of the diagnostic modalities and within different histological sub-sets. | 36 months | |
| Nodal Coverage planning: standard radiotherapy planning vrs DW-MRI | 36 months |
Not provided
Inclusion Criteria:
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.
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.
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.
Not provided
Not provided
Not provided
150 women with histologically confirmed endometrial or cervical carcinoma.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrea Rockall, Professor | Imperial College Healthcare NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth Hospital, Birmingham University Hospitals, Birmingham NHS Foundation Trust | Birmingham | B15 2TH | United Kingdom | |||
Not provided
| OTHER |
| Memorial Sloan Kettering Cancer Center | OTHER |
| Queen Elizabeth Hospital, Gateshead, UK | UNKNOWN |
| Royal Preston Hospital, Lancashire, UK | UNKNOWN |
| Royal Marsden NHS Foundation Trust | OTHER |
| University of Birmingham | OTHER |
Not provided
Not provided
Not provided
Lymph node tissue samples
| Fluorodeoxyglucose-18-PET/CT |
| Diagnostic Test |
|
|
| Fluoro-ethyl-coline-PET/CT | Diagnostic Test |
|
|
| Histopathological findings vrs functional imaging findings | 36 months |
| Birmingham City Hospital, Sandwell & West Birmingham Hospitals NHS Trust |
| Birmingham |
| B18 7QH |
| United Kingdom |
| St Bartholomew's Hospital, Barts Health NHS Trust | London | EC1A 7BE | United Kingdom |
| University College London Hospital | London | NW1 2BU | United Kingdom |
| Hammersmith Hospital, Imperial College Healthcare NHS Trust | London | W12 0HS | United Kingdom |
| Royal Preston Hospital, Lancashire Teaching Hospitals NHS Foundation Trust | Preston | PR2 9HT | United Kingdom |
| The Royal Marsden, The Royal Marsden NHS Foundation Trust | Sutton | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| D008224 | Lymphoma, Follicular |
| D004194 | Disease |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D038524 | Diffusion Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided