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

NCT04689529 | Unknown

• 1 other identifier: 1711-048-898
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Surgery; IMAGE; Chemotherapy Effect

Outcome Measures

Primary Outcomes (1)

• Final pathology report

  Comparison of the difference in size of lesions confirmed by preoperative imaging and final pathology results

  2 weeks after surgery

Study Arms (2)

Breast cancer patients undergoing mastectomy after neoadjuvant chemotherapy

EXPERIMENTAL

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

Diagnostic Test: Preoperative imaging study

Breast cancer patients without neoadjuvant chemotherapy and undergoing mastectomy

ACTIVE COMPARATOR

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.

Diagnostic Test: Preoperative imaging study

Interventions

Preoperative imaging study DIAGNOSTIC_TEST

MRI, Breast ultrasound sonography, mammography

Breast cancer patients undergoing mastectomy after neoadjuvant chemotherapy; Breast cancer patients without neoadjuvant chemotherapy and undergoing mastectomy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 27, 2020
• First Posted: December 30, 2020
• Study Start: March 23, 2018
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2023
• Last Updated: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)