Radiomics of Mp-MRI Assessing NAC Outcome in Breast Cancer

N/AUnknownNCT03592004

Chinese Academy of Sciences500 enrolled

Overview

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.

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

500

Conditions

Breast Cancer Radiomics Neoadjuvant Chemotherapy Multi-parametric MRI

Interventions

neoadjuvant chemotherapyOTHER

neoadjuvant chemotherapy

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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.

Locations (1)

Zhenyu Liu

Beijing, China

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: 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.

Time frame: 5 years

Central Contacts

Zhenyu Liu, Doctor

CONTACT

8613466358609 zhenyu.liu@ia.ac.cn

Data from ClinicalTrials.gov

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