Radiomics of Mp-MRI Assessing NAC Outcome in Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-18

Study Completion Date

2022-06-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer Radiomics Neoadjuvant Chemotherapy Multi-parametric MRI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Guangdong General Hospital

neoadjuvant chemotherapy

Intervention Type OTHER

neoadjuvant chemotherapy

Cancer Hospital Chinese Academy Of Medical Sciences

neoadjuvant chemotherapy

Intervention Type OTHER

neoadjuvant chemotherapy

Beijing Friendship Hospital

neoadjuvant chemotherapy

Intervention Type OTHER

neoadjuvant chemotherapy

Yunnan Cancer Hospital

neoadjuvant chemotherapy

Intervention Type OTHER

neoadjuvant chemotherapy

Liaoning Cancer Hospital

neoadjuvant chemotherapy

Intervention Type OTHER

neoadjuvant chemotherapy

The First Hospital Of China Medical University

neoadjuvant chemotherapy

Intervention Type OTHER

neoadjuvant chemotherapy

Affiliated Hospital Of Hebei University

neoadjuvant chemotherapy

Intervention Type OTHER

neoadjuvant chemotherapy

Interventions

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neoadjuvant chemotherapy

Intervention Type OTHER

Eligibility Criteria

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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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No