Clinical trial NCT01836484: 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
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 type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
Collaborators: name: Birmingham Women's NHS Foundation Trust
name: Case Western Reserve University
name: Guy's and St Thomas' NHS Foundation Trust
name: Hammersmith Hospitals NHS Trust
name: Memorial Sloan-Kettering Cancer Center, USA
name: Queen Elizabeth Hospital, Gateshead, UK
name: Royal Preston Hospital, Lancashire, UK
name: Royal Marsden NHS Foundation Trust
name: University of Birmingham
First posted: 2013-04-22
Enrollment: 162
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 150 women with histologically confirmed endometrial or cervical carcinoma.

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Females 18 years or older; (no upper limit).
2. Patients with histologically confirmed cancer of the cervix or endometrium.

   1. 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;
   2. 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
   3. 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.
3. No contra-indication to FDG-PET/CT, FEC-PET/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.

   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.
5. Able and willing to give written informed consent and to comply with the study protocol procedures

Exclusion Criteria:

1. Known contra-indication 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 breast-feeding.
5. 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
6. Females of childbearing potential must have a negative pregnancy test within three weeks prior to being registered for the study.
7. 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.
8. Participation in another clinical trial (CTIMP or non-CTIMP) where the protocol contains imaging procedures that would occur during the MAPPING study.
9. Medical or psychiatric illness, which makes the patient unsuitable or unable to give informed consent.

Primary outcomes:
measure: Detection rate (DR) vrs false positive rate (FPR) for each of the diagnostic modalities.
timeFrame: 36 months
Secondary outcomes:
measure: Detection rate (DR) vrs false positive rate (FPR) between each of the diagnostic modalities and within different histological sub-sets.
timeFrame: 36 months
measure: Nodal Coverage planning: standard radiotherapy planning vrs DW-MRI
timeFrame: 36 months
measure: Histopathological findings vrs functional imaging findings
timeFrame: 36 months
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital, Birmingham University Hospitals, Birmingham NHS Foundation Trust
city: Birmingham
country: United Kingdom
facility: Birmingham City Hospital, Sandwell & West Birmingham Hospitals NHS Trust
city: London
country: United Kingdom
facility: St Bartholomew's Hospital, Barts Health NHS Trust
city: London
country: United Kingdom
facility: University College London Hospital
city: London
country: United Kingdom
facility: Hammersmith Hospital, Imperial College Healthcare NHS Trust
city: Preston
country: United Kingdom
facility: Royal Preston Hospital, Lancashire Teaching Hospitals NHS Foundation Trust
city: Sutton
country: United Kingdom
facility: The Royal Marsden, The Royal Marsden NHS Foundation Trust
Study officials:
affiliation: Imperial College Healthcare NHS Trust
name: Andrea Rockall, Professor
role: PRINCIPAL_INVESTIGATOR
References: