Computed Tomography (CT) Based Lymphatic Mapping and Localization of Sentinel Lymph Node in Breast Cancer Patients

Phase 3

• Conditions: Breast Cancer
• Interventions: Device: Breast Lesion Localization Needles (interv)

• Registration Number: NCT00952679
• Lead Sponsor: Fudan University

Brief Summary

Breast cancer patients who diagnosed by core needle biopsy or excisional biopsy underwent CT scan to locate the sentinel lymph node (SLN) before SLN biopsy (SLNB) at the same day of surgery. When CT examination performed, those patients were in supine position, with the arms stretched upward but bent at the elbow with the hands at the side of the cranium which similar to the surgical position. After local anesthesia, 2mL of iopamidol was injected subcutaneously to the peritumoral and peri-areolar areas followed by gentle massage for about 1 minute. Contiguous 2-mm-thick CT images that included the breast and axilla were obtained prior to administration of the contrast agent. After 3D CT reconstruction, the SLN was identified as the most inferiorly visible nodule in the axilla connected to the lymphatic vessel on the CT imaging monitor. A professional intervention doctor punctured the defined lymph node guided by the CT monitor using the Breast Lesion Localization Needles (interv). The needle would stay in the patient's axilla until the surgery. All the lymph nodes including the CT defined one and which marked by methylene blue dye or 99mTc-sulfur colloid tracers were removed, which then would be tested by touch imprint cytology for the intraoperative diagnosis. Patients who had positive SLN would receive axillary dissection. The investigators evaluated the new method by comparing lymph nodes defined by CT and traditional ways.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2009-01
• Status Verified: 2009-08
• Study First Submitted: 2009-08-03
• Study First Submitted QC: 2009-08-04
• Last Update Submitted: 2009-08-04
• Study First Posted: 2009-08-06
• Last Update Posted: 2009-08-06
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Breast cancer patients（T1-T2N0）
• Age 18-70
• Accept of SLNB
• Accept our protocol in the informed consent

Exclusion Criteria

• LABC patients
• Age < 18
• History of epilepsy
• History of thyrotoxicosis
• Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental arm	Breast Lesion Localization Needles (interv)	-

Primary Outcome Measures

Name	Time	Method
all cause mortality	five years

Trial Locations

Locations (1)

Cancer hospital; 🇨🇳 Shanghai, Shanghai, China