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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00952679
Enrollment
50
Registered
2009-08-06
Start date
2009-01-31
Completion date
2011-12-31
Last updated
2009-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

The investigators evaluated the new method by comparing lymph nodes defined by CT and traditional ways.

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.

Interventions

DEVICEBreast Lesion Localization Needles (interv)

needles to locate sln in CT monitor guided by CT

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
all cause mortalityfive years

Countries

China

Contacts

Primary ContactJiong Wu, Dr
wujiong1122@vip.sina.com+86 21 64175590
Backup ContactBenlong Yang, Dr
yblqhdx@gmail.com+86 21 64439766

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026