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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Fudan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00952679
First received: August 3, 2009
Last updated: August 4, 2009
Last verified: August 2009
  Purpose

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 Intervention Phase
Breast Cancer
Device: Breast Lesion Localization Needles (interv)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Computed Tomography (CT) Based Lymphatic Mapping and Localization of Sentinel Lymph Node in Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • all cause mortality [ Time Frame: five years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: experimental arm Device: Breast Lesion Localization Needles (interv)
needles to locate sln in CT monitor guided by CT

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Fudan University Cancer institue, Fudan University
ClinicalTrials.gov Identifier: NCT00952679     History of Changes
Other Study ID Numbers: FCW001
Study First Received: August 3, 2009
Last Updated: August 4, 2009
Health Authority: China: Food and Drug Administration

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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014