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Trial Title:
Efficacy and Accuracy of Combined Localization Versus Single Localization in Non-palpable Breast Cancer
NCT ID:
NCT05797454
Condition:
Breast Cancer
Breast-conserving Surgery
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Wire-guided localization and marker clip localization
Description:
Positioning guide wire and marker clip in the center of the lesion
Arm group label:
Untreated patients-combined localization
Intervention type:
Procedure
Intervention name:
Wire-guided localization
Description:
Positioning guide wire in the center of the lesion
Arm group label:
Untreated patients-single localization
Summary:
The standard method for localizing non-palpable breast cancer is currently preoperative
wire-guided localization, its positive margin rate still remains around 20-50%. This
study aims to compare the accuracy and efficacy of wire vs. combined breast tissue
markers in localizing non-palpable breast cancer.
Detailed description:
The standard method for localizing non-palpable breast cancer is currently preoperative
wire-guided localization. This study aims to compare the accuracy and efficacy of wire
vs. combined breast tissue markers in localizing non-palpable breast cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. female patients, age≥18 year
2. A score of ≥ 2 on the Eastern Cooperative Oncology Group scale
3. Patients pathologically diagnosed with untreated breast cancer by core-needle
biopsy, with histologically confirmed non-palpable in situ cancer, including
pleomorphic lobular carcinoma in situ or invasive non-palpable breast cancer that
required localization
4. Patients are willing to undergo breast conserving surgery and have no
contraindications to breast conserving surgery.
Exclusion criteria:
1. Inflammatory breast cancer or Paget's disease
2. Breast deformities and other conditions that impact breast conservation success rate
3. Patients with contraindications to breast-conserving surgery, as well as those with
systemic diseases, mental disorders, or other subjective reasons that may affect
their ability to participate in the trial. Patients with severe bleeding disorders
or coagulation disorders were also excluded
4. Pregnancy or lactation
5. Patients with hookwire, radioactive 125I seed or other localization techniques in
the breast cancer lesions before enrollment
6. Patients with stage IV diseases or unresectable lesions in either breast
7. Patients combined with other diseases that may affect survival
8. Patients with multicentric breast cancer lesions or lesions > 5 cm in diameter on
imaging examinations
9. Patients who have previously undergone radical mastectomy for ipsilateral breast
cancer or chest wall radiotherapy
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Address:
City:
Guangzhou
Zip:
510120
Country:
China
Status:
Recruiting
Contact:
Last name:
Gong Chang, doctor
Phone:
02034070499
Email:
changgong282@163.com
Start date:
February 17, 2023
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Source:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05797454
