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Trial Title:
Computed Tomography (CT) Based Lymphatic Mapping and Localization of Sentinel Lymph Node in Breast Cancer Patients
NCT ID:
NCT00952679
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
The investigators evaluated the new method by comparing lymph nodes defined by CT and traditional ways.
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Breast Lesion Localization Needles (interv)
Description:
needles to locate sln in CT monitor guided by CT
Arm group label:
experimental arm
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer hospital
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhiming Shao, Dr
Phone:
＋86 21 64175590-8800
Email:
zhimingshao@yahoo.com
Investigator:
Last name:
Jiong Wu, Dr
Email:
Principal Investigator
Investigator:
Last name:
Benlong Yang
Email:
Sub-Investigator
Start date:
January 2009
Completion date:
December 2011
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00952679
