Uterine NeoplasmsEMCAMRSNCT02528864
MRI and Metabolomics Biomarkers for Uterine Malignancy
An observational study of Uterine Neoplasms, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Neoplasms
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2015to 31 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients in a tertiary referral center.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital
Guishan, Taoyuan, 333
About this study
Official title: Multiparametric Magnetic Resonance Imaging and Metabolomics Approaches to Study Biomarkers for Uterine Malignancy
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).
Read the 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.
- Conditions
- Uterine Neoplasms
- Keywords
- biomarker, cancer metabolism, chemical exchange saturation transfer, endometrial cancer, diffusion-weighted imaging, magnetic resonance spectroscopy, uterine malignancy
- Medical subject headings
- Uterine Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study start1 Aug 2015
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine NeoplasmsStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gigin Lin, Chang Gung Memorial Hospital
- Investigators
- Gigin Lin, MD, PhD, Principal investigator, Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528864
- Sponsor's protocol ID
- 103-7316A3
- Acronym
- EMCAMRS
- Status last verified
- Jul 2019
- First submitted
- 29 Jul 2015
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 39182135
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric Magnetic Resonance Imaging and Metabolomics Approaches to Study Biomarkers for Uterine Malignancy
- ClinicalTrials.gov ID
- NCT02528864
- Acronym / sponsor ID
- EMCAMRS / 103-7316A3
- Conditions
- Uterine Neoplasms
- Keywords
- biomarker, cancer metabolism, chemical exchange saturation transfer, endometrial cancer, diffusion-weighted imaging, magnetic resonance spectroscopy, uterine malignancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in a tertiary referral center.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Derived from this study: PubMed 39182135Lin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gigin Lin, MD, PhD principal investigator
Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Neoplasms, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02528864, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.