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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04689529
Acronym
PUMP
Enrollment
360
Registered
2020-12-30
Start date
2018-03-23
Completion date
2023-12-31
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Chemotherapy Effect, IMAGE, Surgery

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.

Interventions

DIAGNOSTIC_TESTPreoperative imaging study

MRI, Breast ultrasound sonography, mammography

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Final pathology report2 weeks after surgeryComparison of the difference in size of lesions confirmed by preoperative imaging and final pathology results

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026