Efficacy and Accuracy of Combined Localization Versus Single Localization in Non-palpable Breast Cancer

NCT ID: NCT05797454

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-17

Study Completion Date

2025-12-01

Brief Summary

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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

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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.

Conditions

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Breast Cancer Breast-conserving Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Untreated patients-combined localization

In untreated non-palpable breast cancer patients, positioning focus use wire and marker clip at 1day before operation

Group Type EXPERIMENTAL

Wire-guided localization and marker clip localization

Intervention Type PROCEDURE

Positioning guide wire and marker clip in the center of the lesion

Untreated patients-single localization

In untreated non-palpable breast cancer patients, positioning focus use wire at 1day before operation

Group Type ACTIVE_COMPARATOR

Wire-guided localization

Intervention Type PROCEDURE

Positioning guide wire in the center of the lesion

Interventions

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Wire-guided localization and marker clip localization

Positioning guide wire and marker clip in the center of the lesion

Intervention Type PROCEDURE

Wire-guided localization

Positioning guide wire in the center of the lesion

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Chang Gong

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chang Gong, doctor

Role: CONTACT

02034070499

Facility Contacts

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Gong Chang, doctor

Role: primary

02034070499

Other Identifiers

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SYSKY-2023-129-01

Identifier Type: -

Identifier Source: org_study_id

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