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

June 22, 2023 updated by: Wonshik Han, Seoul National University Hospital

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

  • 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

360

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Korea, Republic of
    • Jongno-gu
      • Seoul, Jongno-gu, Korea, Republic of, 03080
        • Seoul National University Hospital

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Diagnostic test: Preoperative imaging study
MRI, Breast ultrasound sonography, mammography
Active Comparator: 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.
Diagnostic test: Preoperative imaging study
MRI, Breast ultrasound sonography, mammography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Final pathology report
Time Frame: 2 weeks after surgery
Comparison of the difference in size of lesions confirmed by preoperative imaging and final pathology results
2 weeks after surgery

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

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)

March 23, 2018

Primary Completion (Actual)

June 30, 2021

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

December 27, 2020

First Submitted That Met QC Criteria

December 27, 2020

First Posted (Actual)

December 30, 2020

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 22, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1711-048-898

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

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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