Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05797454

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Guangzhou, Guangdong, 510120, China

Location status: Recruiting

Location contact

Gong Chang, doctor

CONTACT

[email protected]

02034070499

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • female patients, age≥18 year
  • A score of ≥ 2 on the Eastern Cooperative Oncology Group scale
  • 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
  • Patients are willing to undergo breast conserving surgery and have no contraindications to breast conserving surgery.

Exclusion criteria

  • Inflammatory breast cancer or Paget's disease
  • Breast deformities and other conditions that impact breast conservation success rate
  • 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
  • Pregnancy or lactation
  • Patients with hookwire, radioactive 125I seed or other localization techniques in the breast cancer lesions before enrollment
  • Patients with stage IV diseases or unresectable lesions in either breast
  • Patients combined with other diseases that may affect survival
  • Patients with multicentric breast cancer lesions or lesions > 5 cm in diameter on imaging examinations
  • Patients who have previously undergone radical mastectomy for ipsilateral breast cancer or chest wall radiotherapy

Treatment and study plan

Wire-guided localization and marker clip localization

Procedure

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

Wire-guided localization

Procedure

Positioning guide wire in the center of the lesion

Primary outcomes

  1. positive margin rate

    Time frame: up to 3 months

    It is defined as the proportion of patients in whom in situ or invasive carcinoma is found in the cavity margins after the first resection, including intraoperative frozen-section analysis and postoperative formalin-fixed paraffin-embedded analysis, subject to postoperative analysis.

Secondary outcomes

  1. Re-operation rate

    Time frame: up to 3 months after first operation

    the proportion of patients which have a positive margin and requires reoperation

  2. The proportion of breast-conserving surgery

    Time frame: up to 3 months after first operation

    It refers to the proportion of patients who have successfully undergone breast-conserving surgery.

  3. IDFS

    Time frame: 2 years, 3 years, and 5 years

    Time from surgery to the first occurrence of local, distant disease recurrence, or death.

Study contacts

Contact information is provided by the study sponsor or research team.

Chang Gong, doctor

CONTACT

[email protected]

02034070499

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Efficacy and Accuracy of Combined Localization Versus Single Localization in Non-palpable Breast Cancer: a Prospective Randomized Control Trial.

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2023
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.