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

NCT00952679 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2009-08-06

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Breast Lesion Localization Needles (interv)

needles to locate sln in CT monitor guided by CT

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-01-31
Completion
2011-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00952679 on ClinicalTrials.gov