Clinical trial · Observational
MRI and Metabolomics Biomarkers for Uterine Malignancy
Multiparametric Magnetic Resonance Imaging and Metabolomics Approaches to Study Biomarkers for Uterine Malignancy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aims of this project are: (1) To establish a research platform in order to integrate multiparametric imaging and metabolomics data for uterine malignancy. (2) Identify potential surrogate biomarkers for early diagnosis of endometrial cancer by using multiparametric magnetic resonance imaging and metabolomics approach. (3) To develop surrogate biomarkers for uterine malignancy, in detecting tumor involvement of myometrium, cervix, and lymph nodes. The investigators propose a 3-year research project to prospectively collect data from 150 female patients 20-80 years old, with clinically diagnosed or suspected to have uterine malignancy. An additional control group comprising 30 patients with normal endometrial tissue will be enrolled. Robust magnetic resonance (MR) imaging techniques including MR spectroscopy (MRS), diffusion-weighted imaging and chemical exchange saturation transfer (CEST) imaging will be applied. Biological samples (tissue, blood, urine) will be analyzed by detailed metabolomics approach (high-resolution MRS).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Neoplasms | Uterine Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Normal endometrium
- description
- Control group (n=30) comprising surgical candidates with normal endometrial tissue will be collected for comparison.
- label
- Endometrial/uterine cancer
- description
- 1. 1st year: 50 eligible patients surgical candidates of endometrial cancer with pre-operative imaging and biological samples collected during operation. 2. 2nd year: Enroll another 50 surgical candidates and complete the data regarding clinical MRS/diffusion-weighted imaging and tissue high resolution MRS. Together with the 50 cancer subjects in the first year there will be in total 100 cancer subjects for analysis. 3. 3rd year: Collect enough positive events with any myometrial involvement (n=30), cervical stromal invasion (n=10) and nodal metastasis (n=10). Together with the 100 cancer subjects in the first and second years there will be in total 150 cancer subjects for analysis.
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLin Y, Wu RC, Lin YC, Huang YL, Lin CY, Lo CJ, Lu HY, Lu KY, Tsai SY, Hsieh CY, Yang LY, Cheng ML, Chao A, Lai CH, Lin G. Endometrial cancer risk stratification using MRI radiomics: corroborating with choline metabolism. Cancer Imaging. 2024 Aug 24;24(1):112. doi: 10.1186/s40644-024-00756-x. PMID 39182135