- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02528864
MRI and Metabolomics Biomarkers for Uterine Malignancy (EMCAMRS)
Multiparametric Magnetic Resonance Imaging and Metabolomics Approaches to Study Biomarkers for Uterine Malignancy
Study Overview
Status
Conditions
Detailed Description
In the 1st year part of this project, the investigators aim to identify the differences between normal endometrium and cancer tissue. Standard conventional MR study plus MRS, diffusion-weighted imaging and CEST sequences will be carried out on 30 eligible surgical candidates for pretreatment clinical assessment.Metabolites in cancer tissue will be collected during operation and analyzed using high resolution MRS, and compared with control group. The primary endpoint of this part is to identify different imaging and metabolomic profiles between normal and cancer subjects. In the 2nd year, the investigators will continue accumulate case number, in order to evaluate the diagnostic accuracy of advanced MR imaging and metabolomics biomarker, in prediction of T staging and myometrial involvement. By the end of 3rd year, the investigators will collect 150 patients, with approximately 20 cases with cervical invasion and 20 cases with nodal metastasis, in order to answer how this approach predicts cervical stromal involvement, nodal and distant metastasis.
The clinical importance of this project is answer the most relevant questions, i.e., prediction of tumor involvement of myometrium, cervix, and lymph nodes. This will be important for understanding the background mechanism of changes identified by MR and 18-F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) /PET, in order to develop novel imaging biomarkers or therapeutic targets. Both molecular imaging and metabolomics are complimentary and share similarities: (1) Comprehensive data representing the information of the living system as a whole (2) information rich data which reflecting the complexity of the biological system (3) ease for longitudinal observation. Metabolomics data provides more details on biochemistry whilst imaging data provides more spatial localization details. A combination of imaging and metabolomics approach would be an ideal tool to develop biomarkers for uterine malignancy. By completion of this project, the investigators expect the most important metabolic biomarkers will be established, and potentially serve as functional tools to guide therapy for patient with uterine malignancy.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Taoyuan
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Guishan, Taoyuan, Taiwan, 333
- Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Female 20 ~ 80 years old.
- Clinically diagnosed or suspected to have uterine malignancy.
- Able to understand and provide signed informed consent.
- Willing to receive standard surgical treatment.
Exclusion Criteria:
- Contraindicated to magnetic resonance study: cardiac pacemaker or cochlear implantation.
- Status post major pelvic surgery, total hip replacement or magnetic substance implantation in the pelvis.
- Significant major systemic disease, such as renal failure, heart failure, stroke, acute myocardial infarction/unstable angina, poor controlled diabetes mellitus, poor controlled hypertension.
- Pregnant or breast-feeding women.
- Moderate to severe dementia.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Normal endometrium
Control group (n=30) comprising surgical candidates with normal endometrial tissue will be collected for comparison.
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Endometrial/uterine cancer
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Overall survival
Time Frame: 1 year
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1 year
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 103-7316A3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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