Radiomics of Mp-MRI Assessing NAC Outcome in Breast Cancer
Radiomics of Multiparametric MRI for Neoadjuvant Chemotherapy Outcomes Assessment in Breast Cancer
1 other identifier
observational
500
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2018
CompletedStudy Start
First participant enrolled
July 18, 2018
CompletedFirst Posted
Study publicly available on registry
July 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedJuly 19, 2018
July 1, 2018
11 months
June 26, 2018
July 17, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
predicting pathological complete response (pCR) or no response (NR)
The value of Radiomics of multiparametric MRI in predicting responses to neoadjuvant chemotherapy, including pathological complete response (pCR) and no response (NR).
20 weeks
5 years for Disease free survival
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
5 years for Overall survival
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.
5 years
Study Arms (7)
Guangdong General Hospital
Cancer Hospital Chinese Academy Of Medical Sciences
Beijing Friendship Hospital
Yunnan Cancer Hospital
Liaoning Cancer Hospital
The First Hospital Of China Medical University
Affiliated Hospital Of Hebei University
Interventions
neoadjuvant chemotherapy
Eligibility Criteria
Chinese
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chinese Academy of Scienceslead
- Guangdong Provincial People's Hospitalcollaborator
- Cancer Institute and Hospital, Chinese Academy of Medical Sciencescollaborator
- Beijing Friendship Hospitalcollaborator
- Yunnan Cancer Hospitalcollaborator
- Liaoning Cancer Hospital & Institutecollaborator
- First Hospital of China Medical Universitycollaborator
- Affiliated Hospital of Hebei Universitycollaborator
Study Sites (1)
Zhenyu Liu
Beijing, 100190, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jie Tian, Doctor
Chinese Academy of Sciences
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 26, 2018
First Posted
July 19, 2018
Study Start
July 18, 2018
Primary Completion
June 1, 2019
Study Completion
June 1, 2022
Last Updated
July 19, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share