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MRI and Metabolomics Biomarkers for Uterine Malignancy

NCT02528864CompletedOBSERVATIONAL

Summary

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).

Key Facts

Lead Sponsor

Chang Gung Memorial Hospital

Enrollment

150

Start Date

2015-08-01

Completion Date

2018-07-31

Study Type

OBSERVATIONAL

Official Title

Multiparametric Magnetic Resonance Imaging and Metabolomics Approaches to Study Biomarkers for Uterine Malignancy

Conditions

Uterine Neoplasms

Eligibility

Age Range

20 Years – 80 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Overall survival

Time frame: 1 year

Locations

Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital, Guishan, Taiwan

Linked Diseases

Uterine Neoplasms

Uterine Neoplasms — a type of gynecological cancer.

Linked Papers

2024-08-24

Endometrial cancer risk stratification using MRI radiomics: corroborating with choline metabolism

Abstract Background and purpose Radiomics offers little explainability. This study aims to develop a radiomics model (Rad-Score) using diffusion-weighted imaging (DWI) to predict high-risk patients for nodal metastasis or recurrence in endometrial cancer (EC) and corroborate with choline metabolism. Materials and methods From August 2015 to July 2018, 356 EC patients were enrolled. Rad-Score was developed using LASSO regression in a training cohort (n = 287) and validated in an independent test cohort (n = 69). MR spectroscopy (MRS) was also used in 230 patients. Nuclear MRS measured choline metabolites in 70 tissue samples. The performance was compared against European Society for Medical Oncology (ESMO) risk groups. A P < .05 denoted statistical significance. Results Rad-Score achieved 71.1% accuracy in the training and 71.0% in the testing cohorts. Incorporating clinical parameters of age, tumor type, size, and grade, Rad-Signature reached accuracies of 73.2% in training and 75.4% in testing cohorts, closely matching the performance to the post-operatively based ESMO's 70.7% and 78.3%. Rad-Score was significantly associated with increased total choline levels on MRS (P = .034) and tissue levels (P = .019). Conclusions Development of a preoperative radiomics risk score, comparable to ESMO clinical standard and associated with altered choline metabolism, shows translational relevance for radiomics in high-risk EC patients. Trial registration This study was registered in ClinicalTrials.gov on 2015–08-01 with Identifier NCT02528864.