Radiomics of Mp-MRI Assessing NAC Outcome in Breast Cancer

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

• Registration Number: NCT03592004
• Lead Sponsor: Chinese Academy of Sciences

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.

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 Timeline

• Study First Submitted: 2018-06-26
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-17
• Last Update Submitted: 2018-07-17
• Study Start: 2018-07-18
• Study First Posted: 2018-07-19
• Last Update Posted: 2018-07-19
• Primary Completion: 2019-06-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Yunnan Cancer Hospital	neoadjuvant chemotherapy	-
The First Hospital Of China Medical University	neoadjuvant chemotherapy	-
Affiliated Hospital Of Hebei University	neoadjuvant chemotherapy	-
Cancer Hospital Chinese Academy Of Medical Sciences	neoadjuvant chemotherapy	-
Beijing Friendship Hospital	neoadjuvant chemotherapy	-
Guangdong General Hospital	neoadjuvant chemotherapy	-
Liaoning Cancer Hospital	neoadjuvant chemotherapy	-

Primary Outcome Measures

Name	Time	Method
predicting pathological complete response (pCR) or no response (NR)	20 weeks	The value of Radiomics of multiparametric MRI in predicting responses to neoadjuvant chemotherapy, including pathological complete response (pCR) and no response (NR).
5 years for Overall survival	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.
5 years for Disease free survival	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.

Trial Locations

Locations (1)

Zhenyu Liu; 🇨🇳 Beijing, China