MRI and Metabolomics Biomarkers for Uterine Malignancy

NCT02528864 | Completed

• 1 other identifier: 103-7316A3
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Uterine Neoplasms

Keywords

biomarker; cancer metabolism; chemical exchange saturation transfer; endometrial cancer; diffusion-weighted imaging; magnetic resonance spectroscopy; uterine malignancy

Outcome Measures

Primary Outcomes (1)

• Overall survival

  1 year

Study Arms (2)

Normal endometrium

Control group (n=30) comprising surgical candidates with normal endometrial tissue will be collected for comparison.

Endometrial/uterine cancer

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.

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in a tertiary referral center.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital

Guishan, Taoyuan, 333, Taiwan

Location

Related Publications (1)

• Lin 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 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

1. Plasma sample preparation for global metabolites analysis and lipidomic analysis: 2. Urine samples will be diluted with distilled water. Samples are centrifuged at 14,000 g for 5 min, and the supernatants will be collected for LC-MS analysis. 3. Cellular metabolites extraction: Extraction method will be carried out by the method modified by Munger and Patterson. The medium will be aspirated from culture plates containing cells and 80% methanol (at -80°C) will immediately be added.

MeSH Terms

Conditions

Uterine Neoplasms; Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Gigin Lin, MD, PhD

  Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Radiology

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: August 19, 2015
• Study Start: August 1, 2015
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)