Computed Tomography (CT) Based Lymphatic Mapping and Localization of Sentinel Lymph Node in Breast Cancer Patients
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 breast-cancer
Started Jan 2009
Shorter than P25 for phase_3 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 3, 2009
CompletedFirst Posted
Study publicly available on registry
August 6, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedAugust 6, 2009
August 1, 2009
Same day
August 3, 2009
August 4, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
all cause mortality
five years
Study Arms (1)
experimental arm
EXPERIMENTALInterventions
needles to locate sln in CT monitor guided by CT
Eligibility Criteria
You may qualify if:
- Breast cancer patients（T1-T2N0）
- Age 18-70
- Accept of SLNB
- Accept our protocol in the informed consent
You may not qualify if:
- LABC patients
- Age \< 18
- History of epilepsy
- History of thyrotoxicosis
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Cancer hospital
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 3, 2009
First Posted
August 6, 2009
Study Start
January 1, 2009
Primary Completion
January 1, 2009
Study Completion
December 1, 2011
Last Updated
August 6, 2009
Record last verified: 2009-08