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

• Sponsor: Fudan University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00952679
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Duration (Months): 35
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Device: Breast Lesion Localization Needles (interv)	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Computed Tomography (CT) Based Lymphatic Mapping and Localization of Sentinel Lymph Node in Breast Cancer Patients
• Study Start Date: Jan 1, 2009
• Anticipated Primary Completion Date: Jan 1, 2009
• Anticipated Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: experimental arm	Device: Breast Lesion Localization Needles (interv); needles to locate sln in CT monitor guided by CT

Outcome Measures

Primary Outcome Measures

1. all cause mortality [five years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer hospital	Shanghai	Shanghai	China	200032

Sponsors and Collaborators

• Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00952679
• Other Study ID Numbers: FCW001
• First Posted: Aug 6, 2009
• Last Update Posted: Aug 6, 2009
• Last Verified: Aug 1, 2009

• Keywords provided by , ,: The investigators evaluated the new method by comparing lymph nodes defined by CT and traditional ways.
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Aug 6, 2009