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

NCT ID: NCT04689529

Last Updated: 2023-06-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-23
• Study Completion Date: 2023-12-31

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.

Conditions

Breast Cancer; Surgery; IMAGE; Chemotherapy Effect

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Breast cancer patients undergoing mastectomy after neoadjuvant chemotherapy

Patients who underwent total mastectomy (including simultaneous reconstruction surgery) through preoperative examinations (MRI, breast ultrasound, mammography, etc.) after receiving neoadjuvant chemotherapy

Group Type: EXPERIMENTAL

Preoperative imaging study

Intervention Type: DIAGNOSTIC_TEST

MRI, Breast ultrasound sonography, mammography

Breast cancer patients without neoadjuvant chemotherapy and undergoing mastectomy

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.

Group Type: ACTIVE_COMPARATOR

Preoperative imaging study

Intervention Type: DIAGNOSTIC_TEST

MRI, Breast ultrasound sonography, mammography

Interventions

Preoperative imaging study

MRI, Breast ultrasound sonography, mammography

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wonshik Han

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Countries

South Korea

Other Identifiers

1711-048-898

Identifier Type: -

Identifier Source: org_study_id