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

Breast Cancer Clinical Trial

— PUMP  

Official title:

The Percentage of Unnecessary Mastectomy Due to False Size Prediction by Preoperative Imaging Studies in Breast Cancer Patients Who Underwent Neoadjuvant Chemotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04689529
• Other study ID #: 1711-048-898
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 23, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 360
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chemotherapy Effect
• IMAGE
• Surgery

Intervention

Diagnostic Test:
• Preoperative imaging study
MRI, Breast ultrasound sonography, mammography

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Jongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Final pathology report	Comparison of the difference in size of lesions confirmed by preoperative imaging and final pathology results	2 weeks after surgery