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

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Breast Lesion Localization Needles (interv)

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring The investigators evaluated the new method by comparing lymph nodes defined by CT and traditional ways.

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cancer hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

experimental arm

Arm Description

Outcomes

Primary Outcome Measures

all cause mortality

Secondary Outcome Measures

Full Information

NCT ID

NCT00952679

First Posted

August 3, 2009

Last Updated

August 4, 2009

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT00952679

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2009

Overall Recruitment Status

Unknown status

Study Start Date

January 2009 (undefined)

Primary Completion Date

January 2009 (Anticipated)

Study Completion Date

December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Fudan University

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

experimental arm

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Breast Lesion Localization Needles (interv)

Intervention Description

needles to locate sln in CT monitor guided by CT

Primary Outcome Measure Information:

Title

all cause mortality

Time Frame

five years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jiong Wu, Dr

Phone

＋86 21 64175590

Ext

8600

wujiong1122@vip.sina.com

First Name & Middle Initial & Last Name or Official Title & Degree

Benlong Yang, Dr

Phone

+86 21 64439766

yblqhdx@gmail.com

Facility Information:

Facility Name

Cancer hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhiming Shao, Dr

Phone

＋86 21 64175590-8800

zhimingshao@yahoo.com

First Name & Middle Initial & Last Name & Degree

Jiong Wu, Dr

First Name & Middle Initial & Last Name & Degree

Benlong Yang

12. IPD Sharing Statement

Learn more about this trial

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

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