Clinical trial NCT02528864: MRI and Metabolomics Biomarkers for Uterine Malignancy
Official title: Multiparametric Magnetic Resonance Imaging and Metabolomics Approaches to Study Biomarkers for Uterine Malignancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Neoplasms
Keywords: biomarker
cancer metabolism
chemical exchange saturation transfer
endometrial cancer
diffusion-weighted imaging
magnetic resonance spectroscopy
uterine malignancy
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 150
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in a tertiary referral center.

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Guishan
country: Taiwan
facility: Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital
state: Taoyuan
Study officials:
affiliation: Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital
name: Gigin Lin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: