Radiomics of Mp-MRI Assessing NAC Outcome in Breast Cancer

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
• Conditions: Breast Cancer; Neoadjuvant Chemotherapy; Radiomics; Multi-parametric MRI
• Intervention / Treatment: Other: neoadjuvant chemotherapy

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

• Study Contact: Name: Zhenyu Liu, Doctor; Phone Number: 8613466358609; Email: zhenyu.liu@ia.ac.cn

Study Locations

• China
  • Beijing, China, 100190
    • Recruiting
    • Zhenyu Liu
    • Contact: Zhenyu Liu, Doctor; Phone Number: 8613466358609

Participation Criteria

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Beijing Friendship Hospital	Other: neoadjuvant chemotherapy; neoadjuvant chemotherapy
Guangdong General Hospital	Other: neoadjuvant chemotherapy; neoadjuvant chemotherapy
Cancer Hospital Chinese Academy Of Medical Sciences	Other: neoadjuvant chemotherapy; neoadjuvant chemotherapy
Yunnan Cancer Hospital	Other: neoadjuvant chemotherapy; neoadjuvant chemotherapy
Liaoning Cancer Hospital	Other: neoadjuvant chemotherapy; neoadjuvant chemotherapy
The First Hospital Of China Medical University	Other: neoadjuvant chemotherapy; neoadjuvant chemotherapy
Affiliated Hospital Of Hebei University	Other: neoadjuvant chemotherapy; neoadjuvant chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chinese Academy of Sciences
• Collaborators: Beijing Friendship Hospital; Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Guangdong Provincial People's Hospital; Affiliated Hospital of Hebei University; First Hospital of China Medical University; Liaoning Tumor Hospital & Institute; Yunnan Cancer Hospital
• Investigators: Principal Investigator: Jie Tian, Doctor, Chinese Academy of Sciences

Study record dates

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: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• 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