Radiomics of Mp-MRI Assessing NAC Outcome in Breast Cancer
July 17, 2018 updated by: Zhenyu Liu, Chinese Academy of Sciences
Radiomics of Multiparametric MRI for Neoadjuvant Chemotherapy Outcomes Assessment in Breast Cancer
This is a single-arm, multicentre study that aims to assess whether Radiomics combining multiparametric MRI and clinical data could be a good predictor of the responses to neoadjuvant chemotherapy in Breast Cancer.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
Patients undergo multiparametric MRI (including T2WI, DWI and DCE-MRI) at baseline, after 2 courses of neoadjuvant chemotherapy, and prior to the surgery at least 8 weeks after the treatment procedure. Patients undergo biopsy test in one week after the baseline MRI scan to detect the biomarkers including ER, PR, Her-2 and Ki-67, which can be used to select the treatment plan referring to the NCCN clinical guidelines. After the surgery, responses to neoadjuvant chemotherapy are determined according to the histopathologically examination of the surgically resected specimens.
After completion of treatment procedure, patients are followed up for 5 years.
Study Type
Observational
Enrollment (Anticipated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Beijing, China, 100190
- Recruiting
- Zhenyu Liu
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Contact:
- Zhenyu Liu, Doctor
- Phone Number: 8613466358609
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Chinese
Description
Inclusion Criteria:
- biopsy-proven invasive breast cancer;
- received complete neoadjuvant chemotherapy and no treatment has been done before;
- surgery was performed after completion of neoadjuvant chemotherapy, after which pCR was confirmed by postoperative pathological examination;
- pretreatment MRI data within a month before the start of the treatment was eligible, including T2WI, DWI and DCE-MRI.
Exclusion Criteria:
- not completing neoadjuvant chemoradiotherapy;
- not undergoing surgery at our hospital, or pCR was not assessed;
- lack of T2WI, or DWI or DCE-MRI data;
- insufficient MRI quality to obtain measurements (e.g., owing to motion artifacts);
- had unilateral multifocal cancers, and the correlation between the tumor in MR images and postoperative pathological examination was uncertain.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Beijing Friendship Hospital
|
neoadjuvant chemotherapy
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Guangdong General Hospital
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neoadjuvant chemotherapy
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Cancer Hospital Chinese Academy Of Medical Sciences
|
neoadjuvant chemotherapy
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Yunnan Cancer Hospital
|
neoadjuvant chemotherapy
|
|
Liaoning Cancer Hospital
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neoadjuvant chemotherapy
|
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The First Hospital Of China Medical University
|
neoadjuvant chemotherapy
|
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Affiliated Hospital Of Hebei University
|
neoadjuvant chemotherapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
predicting pathological complete response (pCR) or no response (NR)
Time Frame: 20 weeks
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The value of Radiomics of multiparametric MRI in predicting responses to neoadjuvant chemotherapy, including pathological complete response (pCR) and no response (NR).
|
20 weeks
|
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5 years for Disease free survival
Time Frame: 5 years
|
The association between Radiomics of multiparametric MRI and disease free survival (DFS), which defined as the time from the beginning of neoadjuvant chemotherapy to the confirmed time of recurrence or metastatic disease, or death due to any other cause.
|
5 years
|
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5 years for Overall survival
Time Frame: 5 years
|
The association between Radiomics of multiparametric MRI and overall survival (OS), which defined as the time from the beginning of neoadjuvant chemotherapy to the death with any causes.
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5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jie Tian, Doctor, Chinese Academy of Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 18, 2018
Primary Completion (Anticipated)
June 1, 2019
Study Completion (Anticipated)
June 1, 2022
Study Registration Dates
First Submitted
June 26, 2018
First Submitted That Met QC Criteria
July 17, 2018
First Posted (Actual)
July 19, 2018
Study Record Updates
Last Update Posted (Actual)
July 19, 2018
Last Update Submitted That Met QC Criteria
July 17, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZLiu
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.