Prospective Validation and Application of an Artificial Intelligence-based Model for Evaluating the Efficacy of Breast Cancer Patients After Neoadjuvant Therapy

October 17, 2024 updated by: PENG YUAN, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Breast cancer has become the world's number one cancer. While its therapeutic efficacy is increasing, how to achieve non-invasive evaluation of the efficacy of neoadjuvant therapy (NAT) for breast cancer patients and thus avoid surgery has become a bottleneck problem that needs to be broken through in clinical diagnosis and treatment. Existing non-invasive evaluation strategies are limited to single-center, single-modality modeling, and have problems such as low performance and poor versatility. Therefore, in the early stage of this study, multi-modality breast cancer patient data from multiple centers across the country were collected and the establishment of an artificial intelligence (AI) efficacy prediction model was preliminarily completed. On this basis, this project intends to further improve the multi-center prospective validation study of the prediction model. The research results will help solve the scientific problem of non-invasive judgment of NAT efficacy in breast cancer patients and provide a new paradigm for the research of high-performance AI diagnosis and treatment auxiliary systems applicable to multiple centers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

(1) Prospectively collect breast MRI original images (DCE and ADC sequences) and corresponding clinical and surgical pathological data of multi-center breast cancer patients before and after neoadjuvant treatment, store and transport them via mobile hard disks, and input the processed data into the established efficacy determination model stored in a dedicated cloud server; (2) Use artificial intelligence to automatically delineate the ROI area and extract the imaging genomics and deep learning features therein, and combine the clinical pathological characteristics of the patients to further prospectively verify the effectiveness of the established pCR efficacy determination model.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer hospital, Chinese Academy of Medical Sciences
        • Contact:
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Sanhuan Cancer Hospital, Chaoyang District, Beijing(Cancer Hospital, Chinese Academy of Medical Sciences, close medical alliance)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This study adopts sequential enrollment (continuously recruiting patients until the sample size requirement is met). The subjects are patients with neoadjuvant treatment for breast cancer who were treated in Beijing Second Hospital, Beijing Luhe Hospital Affiliated to Capital Medical University, and Beijing Sanhuan Cancer Hospital from January 2024 to December 2026. Each independent medical center will include 100 patients, for a total of 300 patients.

Description

Inclusion Criteria:

  • Patients who were treated in the above research centers between January 1, 2024 and October 31, 2025;
  • ≥18 years old, female, ECOG score ≤2;
  • Pathological biopsy confirmed invasive breast cancer;
  • AJCC (8th edition) stage I-III;
  • MRI imaging data before and after neoadjuvant therapy;
  • Planned mastectomy or breast-conserving surgery after neoadjuvant therapy, and postoperative pathological information obtained.

Exclusion Criteria:

  • Bilateral breast cancer, multiple lesions, or occult breast cancer;
  • Poor MRI data quality;
  • Patients who had received other anti-tumor treatments before enrollment;
  • Patients with other malignant tumors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast cancer patients who achieved pathological complete response after neoadjuvant therapy
All enrolled breast cancer patients received normal neoadjuvant therapy and subsequent surgery without intervention in the diagnosis and treatment process. They were judged to have achieved pathological complete respone based on surgical pathology.
Other: no intervention
no intervention
Breast cancer patients who did not achieve pathological complete response after neoadjuvant therapy
All enrolled breast cancer patients received normal neoadjuvant therapy and subsequent surgery without intervention in the diagnosis and treatment process. They were judged as not achieving pathological complete respone based on surgical pathology.
Other: no intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Breast MRI radiomics characteristics of breast cancer patients during neoadjuvant therapy
Time Frame: Breast cancer MRI images before neoadjuvant therapy and immediately after completing neoadjuvant therapy
Breast cancer MRI images before neoadjuvant therapy and immediately after completing neoadjuvant therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Study Director: peng yuan, doctor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 24, 2024

First Submitted That Met QC Criteria

October 17, 2024

First Posted (Actual)

October 18, 2024

Study Record Updates

Last Update Posted (Actual)

October 18, 2024

Last Update Submitted That Met QC Criteria

October 17, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-1- 4021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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