Unnecessary Mastectomy Due to False Size Prediction by Preoperative Imaging Studies in Breast Cancer

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer; Surgery; IMAGE; Chemotherapy Effect
• Interventions: Diagnostic Test: Preoperative imaging study

• Registration Number: NCT04689529
• Lead Sponsor: Seoul National University Hospital

Brief Summary

* The surgical method for breast cancer is determined according to the size and location of the remaining lesions after prior chemotherapy.

* There are many patients who were able to undergo partial resection when confirming the final results of patients who underwent total resection after prior chemotherapy.

* Therefore, we would like to investigate whether it is effective to make decisions based on the results of pre-operative tests after prior chemotherapy.

Detailed Description

In a study published by Jennifer F. et al., sensitivity to lesions remaining after prior chemotherapy of breast magnetic resonance imaging was measured as 83%, specificity 47%, PPV 47%, NPV 83%, and accuracy 74%. have.

Most of the preoperative examinations after prior chemotherapy have the most confidence in the results of breast magnetic resonance imaging, but there will be other factors to predict this result as there will be differences in the actual postoperative pathology results. .

After prior chemotherapy, total resection was performed, and cases where partial resection is possible in the postoperative pathologic results are prospectively identified and compared and analyzed.

Study Timeline

• Study Start: 2018-03-23
• Study First Submitted: 2020-12-27
• Study First Submitted QC: 2020-12-27
• Study First Posted: 2020-12-30
• Primary Completion: 2021-06-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-22
• Last Update Posted: 2023-06-26
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Breast cancer patients over 20 years of age undergoing surgery at Seoul National University Hospital
• Patients to undergo total mastectomy
• Patients who received neoadjuvant chemotherapy and undergoing total mastectomy were the main subjects, but as a control group, patients who did not receive neoadjuvant chemotherapy but undergoing total mastectomy were included as subjects.

Exclusion Criteria

• In case of total mastectomy at the request of the patient
• Except for cases where total resection is performed regardless of size because it is a lesion under the areola and is close to the nipple.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breast cancer patients undergoing mastectomy after neoadjuvant chemotherapy	Preoperative imaging study	Patients who underwent total mastectomy (including simultaneous reconstruction surgery) through preoperative examinations (MRI, breast ultrasound, mammography, etc.) after receiving neoadjuvant chemotherapy
Breast cancer patients without neoadjuvant chemotherapy and undergoing mastectomy	Preoperative imaging study	Patients who underwent total mastectomy (including simultaneous reconstruction surgery) through preoperative examinations (MRI, breast ultrasound, mammography, etc.) even in patients who did not receive neoadjuvant chemotherapy as a control group.

Primary Outcome Measures

Name	Time	Method
Final pathology report	2 weeks after surgery	Comparison of the difference in size of lesions confirmed by preoperative imaging and final pathology results

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Jongno-gu, Korea, Republic of