Radiomics of Mp-MRI Assessing NAC Outcome in Breast Cancer

Study Overview
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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.

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.

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

Conditions
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Breast Cancer, Radiomics, Neoadjuvant Chemotherapy, Multi-parametric MRI

Intervention / Treatment
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* Other: neoadjuvant chemotherapy


Participation Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Guangdong General Hospital<br> | Other: neoadjuvant chemotherapy<br>* neoadjuvant chemotherapy<br>|
| Cancer Hospital Chinese Academy Of Medical Sciences<br> | Other: neoadjuvant chemotherapy<br>* neoadjuvant chemotherapy<br>|
| Beijing Friendship Hospital<br> | Other: neoadjuvant chemotherapy<br>* neoadjuvant chemotherapy<br>|
| Yunnan Cancer Hospital<br> | Other: neoadjuvant chemotherapy<br>* neoadjuvant chemotherapy<br>|
| Liaoning Cancer Hospital<br> | Other: neoadjuvant chemotherapy<br>* neoadjuvant chemotherapy<br>|
| The First Hospital Of China Medical University<br> | Other: neoadjuvant chemotherapy<br>* neoadjuvant chemotherapy<br>|
| Affiliated Hospital Of Hebei University<br> | Other: neoadjuvant chemotherapy<br>* neoadjuvant chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |