Radiomics of Mp-MRI Assessing NAC Outcome in Breast Cancer

Breast Cancer Clinical Trial

Official title:

Radiomics of Multiparametric MRI for Neoadjuvant Chemotherapy Outcomes Assessment in Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03592004
• Other study ID #: ZLiu
• Status: Recruiting
• Start date: July 18, 2018
• Est. completion date: June 1, 2022

Study information

• Verified date: July 2018
• Source: Chinese Academy of Sciences
• Contact: Zhenyu Liu, Doctor
• Phone: 8613466358609
• Email: zhenyu.liu[@]ia.ac.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Multi-parametric MRI
• Neoadjuvant Chemotherapy
• Radiomics

Intervention

Other:
• neoadjuvant chemotherapy
neoadjuvant chemotherapy

Locations

Country	Name	City	State
China	Zhenyu Liu	Beijing

Sponsors (8)

Lead Sponsor	Collaborator
Chinese Academy of Sciences	Affiliated Hospital of Hebei University, Beijing Friendship Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, First Hospital of China Medical University, Guangdong General Hospital, Liaoning Tumor Hospital & Institute, Yunnan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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