Unnecessary Mastectomy Due to False Size Prediction by Preoperative Imaging Studies in Breast Cancer (PUMP)
Primary Purpose
Breast Cancer, Surgery, IMAGE
Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Preoperative imaging study
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer
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.
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Breast cancer patients undergoing mastectomy after neoadjuvant chemotherapy
Breast cancer patients without neoadjuvant chemotherapy and undergoing mastectomy
Arm Description
Patients who underwent total mastectomy (including simultaneous reconstruction surgery) through preoperative examinations (MRI, breast ultrasound, mammography, etc.) after receiving neoadjuvant chemotherapy
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.
Outcomes
Primary Outcome Measures
Final pathology report
Comparison of the difference in size of lesions confirmed by preoperative imaging and final pathology results
Secondary Outcome Measures
Full Information
NCT ID
NCT04689529
First Posted
December 27, 2020
Last Updated
June 22, 2023
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04689529
Brief Title
Unnecessary Mastectomy Due to False Size Prediction by Preoperative Imaging Studies in Breast Cancer
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 23, 2018 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Surgery, IMAGE, Chemotherapy Effect
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Breast cancer patients undergoing mastectomy after neoadjuvant chemotherapy
Arm Type
Experimental
Arm Description
Patients who underwent total mastectomy (including simultaneous reconstruction surgery) through preoperative examinations (MRI, breast ultrasound, mammography, etc.) after receiving neoadjuvant chemotherapy
Arm Title
Breast cancer patients without neoadjuvant chemotherapy and undergoing mastectomy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Preoperative imaging study
Intervention Description
MRI, Breast ultrasound sonography, mammography
Primary Outcome Measure Information:
Title
Final pathology report
Description
Comparison of the difference in size of lesions confirmed by preoperative imaging and final pathology results
Time Frame
2 weeks after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongno-gu
ZIP/Postal Code
03080
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Unnecessary Mastectomy Due to False Size Prediction by Preoperative Imaging Studies in Breast Cancer
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