Sienna and Sentimag in Sentinel Lymph Node Biopsy (Sienna)

February 15, 2017 updated by: Yolanda Chan

Sentinel Lymph Node Biopsy Using a Magnetic Tracer Versus Standard Radio-isotope Technique in Early Breast Cancer

The aim of this study is to evaluate a new method for the localization of breast cancer sentinel lymph node using Sienna+® and Sentimag® detection in comparison to our standard techniques with radio-isotopes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The use of radioisotope with or without blue dye has long become the gold standard for sentinel lymph node localization in the management of breast cancer. The latest evidence from a number of European trials has proven that a new tracer agent, superparamagnetic iron oxide particles (SPIOs, Sienna+®), is non-inferior to the standard method of lymphatic mapping. Its application and feasibility has yet been tried in most Asian countries.

This is a prospective paired comparison trial involving both the new magnetic technique and the standard method. Patients with preoperative diagnosis of invasive carcinoma or ductal carcinoma in-situ of the breast undergoing SNOLL (Sentinel node and occult lesion localization) will be recruited from the Breast Centre of Kwong Wah Hospital. Informed consent will be obtained. All patients recruited will receive subcutaneous injection of 2 ml of Sienna+® diluted with saline to 5 ml at Breast Centre in the morning of operation, followed by five minutes of massage to the injection site. Before incision, on-table transcutaneous detection with the handheld magnetometer are carried out after at least 20 minutes from injection. Intraoperative counts of sentinel lymph nodes identified as well as the ex-vivo counts of excised nodes are also measured. All procedures are supplemented with localization by radioisotope. All lymph nodes excised will be sent for histopathological examination.

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women diagnosed with early-stage breast cancer (including ductal carcinoma in-situ) who are clinically or radiologically node-negative and consenting for sentinel lymph node biopsy
  • Patients undergoing SNOLL (Sentinel node and occult lesion localization) with the use of radio-isotope in our Breast Centre

Exclusion Criteria:

  • Patients with clinically T3 or T4 breast cancer and any contraindication to sentinel lymph node biopsy
  • Patients with pacemaker or other implantable device in the chest wall

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of successful procedures for sentinel lymph node identification (identification rate per patient) by the magnetic method compared with the standard method
Time Frame: Two years
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yolanda Chan

Investigators

  • Principal Investigator: Yolanda Chan, MBBS, Kwong Wah Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2017

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

December 31, 2018

Study Registration Dates

First Submitted

January 26, 2017

First Submitted That Met QC Criteria

January 26, 2017

First Posted (Estimate)

January 30, 2017

Study Record Updates

Last Update Posted (Actual)

February 16, 2017

Last Update Submitted That Met QC Criteria

February 15, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 107-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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