NCT03036475

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Mar 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

February 16, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

January 26, 2017

Last Update Submit

February 15, 2017

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Proportion of successful procedures for sentinel lymph node identification (identification rate per patient) by the magnetic method compared with the standard method

    Two years

Interventions

Sienna+ injectionDEVICE

Subcutaneous injection of Sienna+ in the morning of operation day

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Yolanda Chan, MBBS

    Kwong Wah Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yolanda Chan, MBBS

CONTACT

+852 9785 4221chy168@ha.org.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Consultant

Study Record Dates

First Submitted

January 26, 2017

First Posted

January 30, 2017

Study Start

March 1, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

February 16, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share