A comparison of intraoperative techniques to determine margin in breast conserving surgery

Phase 3

• Conditions: Early breast cancer patients with breast conserving surgery; Breast cancer, breast conserving surgery, breast deformity, quality of life, re wide excision

• Registration Number: TCTR20230328002
• Lead Sponsor: Self-funded

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-28
• Study Completion: 2023-12-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: Female
• Target Recruitment: 108

Inclusion Criteria

1. Breast cancer patients with palpation of the breast mass
2. Patients with early breast cancer (invasive breast carcinoma ,cT1 to 2 or N0 to 1,M0)
3. Patients with early breast cancer undergoing breast-conserving mastectomy

Exclusion Criteria

1. Breast cancer patients receiving chemotherapy or radiation before surgery
2. Breast cancer patients with pregnancy
3. The patient who had a full breast surgery after breast conserving surgery.
4. Patients with the history of allergy to Isosulfan blue

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of finding cancerous cells During surgery Ultrasound alone or in conjunction with tracer dye

Secondary Outcome Measures

Name	Time	Method
Rate of repeated breast cancer surgery Within 6 months after the surgery Surgery or surgeries count/medical records,Rate of breast deformity and quality of life after surgery 3 and 6 months after surgery EORTC QLQ-C30 and EORTC QLQ-BR45