Radiomics of Mp-MRI Assessing NAC Outcome in Breast Cancer

Chinese Academy of Sciences

Status: Unknown

Conditions: Breast Cancer; Radiomics; Neoadjuvant Chemotherapy; Multi-parametric MRI

Treatments: Other: neoadjuvant chemotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT03592004

ZLiu

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 7 patient groups

Guangdong General Hospital

Treatment:

Other: neoadjuvant chemotherapy

Cancer Hospital Chinese Academy Of Medical Sciences

Treatment:

Other: neoadjuvant chemotherapy

Beijing Friendship Hospital

Treatment:

Other: neoadjuvant chemotherapy

Yunnan Cancer Hospital

Treatment:

Other: neoadjuvant chemotherapy

Liaoning Cancer Hospital

Treatment:

Other: neoadjuvant chemotherapy

The First Hospital Of China Medical University

Treatment:

Other: neoadjuvant chemotherapy

Affiliated Hospital Of Hebei University

Treatment:

Other: neoadjuvant chemotherapy