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

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ClinicalTrials.gov Identifier: NCT00952679
Recruitment Status : Unknown
Verified August 2009 by Fudan University.
Recruitment status was:  Recruiting
First Posted : August 6, 2009
Last Update Posted : August 6, 2009
Sponsor:
Information provided by:

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  (Clinical Trial)
Estimated Enrollment : 50 participants
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 : January 2009
Estimated Primary Completion Date : January 2009
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 [ Time Frame: five years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00952679


Contacts
Contact: Jiong Wu, Dr +86 21 64175590 ext 8600 wujiong1122@vip.sina.com
Contact: Benlong Yang, Dr +86 21 64439766 yblqhdx@gmail.com

Locations
China, Shanghai
Cancer hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Zhiming Shao, Dr    +86 21 64175590-8800    zhimingshao@yahoo.com   
Principal Investigator: Jiong Wu, Dr         
Sub-Investigator: Benlong Yang         
Sponsors and Collaborators
Fudan University
More Information

Responsible Party: Fudan University Cancer institue, Fudan University
ClinicalTrials.gov Identifier: NCT00952679     History of Changes
Other Study ID Numbers: FCW001
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: August 6, 2009
Last Verified: August 2009

Keywords provided by Fudan University:
The investigators evaluated the new method by comparing lymph nodes defined by CT and traditional ways.

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases