NCT02336737

Brief Summary

The purpose of this pivotal study is to provide prospective evidence that the SentiMag®/SiennaXP® is safe and non-inferior to the current standard of care for lymph node localization in patients with breast cancer as part of a sentinel lymph node biopsy (SLNB) procedure and to summarize measures of product safety and performance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

6 active sites

Status
completed

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

Study Start

First participant enrolled

January 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 13, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

November 3, 2020

Completed
Last Updated

November 23, 2020

Status Verified

November 1, 2020

Enrollment Period

11 months

First QC Date

January 7, 2015

Results QC Date

August 12, 2020

Last Update Submit

November 6, 2020

Conditions

Breast Cancer

Keywords

breast cancersentinel lymph node biopsy

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Detected Lymph Nodes

    The proportion of lymph nodes detected intraoperatively by SentiMag and SiennaXP in relation the proportion of lymph nodes detected by the combination of Technetium Sulfur Colloid and Isosulfan blue dye

    During surgical procedure <1 hour

  • Safety of SiennaXP and SentiMag® as Indicated by Adverse Events and Serious Adverse Events and Their Relatedness to the Detection Method or Procedure.

    Number of Participants with Adverse Events relating to Sienna XP Injection

    3-6 weeks

Secondary Outcomes (2)

  • Nodal Concordance: Number of Nodes Identified by Both Test and Control Out of Nodes Identified by Control

    Intraoperative <1 hour

  • Number of Participants With Lymph Nodes Detected by Combined Radioisotope,Blue Dye and Magnetic Technique

    Intraoperative <1 hour

Study Arms (1)

SiennaXP injection

EXPERIMENTAL

Single injection of SiennaXP in addition to comparator single dose of radioisotope (Technetium Tc99m Sulfur Colloid) and single dose of isosulfan blue dye. Lymph node localization using the SentiMag handheld intraoperative localization system in addition to localization with standard of care handheld gamma probe.

Device: SiennaXPDrug: Technetium Tc99m Sulfur ColloidDrug: Isosulfan blue dye

Interventions

SiennaXPDEVICE

Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe

SiennaXP injection
Technetium Tc99m Sulfur ColloidDRUG

Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid)

Also known as: Radioisotope
SiennaXP injection
Isosulfan blue dyeDRUG

Injection of a single dose of isosulfan blue dye

Also known as: Blue dye
SiennaXP injection

Eligibility Criteria

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

You may qualify if:

  • Subjects with a diagnosis of primary breast cancer or subjects with pure ductal carcinoma in situ (DCIS).
  • Subjects scheduled for surgical intervention, with a sentinel lymph node biopsy procedure being a part of the surgical plan.
  • Subjects aged 18 years or more at the time of consent.
  • Subjects with an ECOG (Eastern Cooperative Oncology Group) performance status of Grade 0 - 2.
  • Subject has a clinical negative node status (i.e. T0-3, N0, M0).

You may not qualify if:

  • The subject is pregnant or lactating.
  • The subject has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes.
  • The subject has a known hypersensitivity to Isosulfan Blue Dye.
  • The subject has participated in another investigational drug study within 30 days of scheduled surgery.
  • Subject has had either a) previous axilla surgery, b) reduction mammoplasty, or c) lymphatic function that is impaired in the surgeon's judgment.
  • Subject has had preoperative radiation therapy to the affected breast or axilla.
  • Subject has received a Feraheme® (ferumoxytol) Injection within the past 6 months.
  • Subject has intolerance or hypersensitivity to iron or dextran compounds or to SiennaXP.
  • Subject has an iron overload disease.
  • Subject has pacemaker or other implantable device in the chest wall.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of California San Diego Moores Cancer Center

La Jolla, California, 92093-0698, United States

Location

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

UCSF Carol Franc Buck Breast Care Center

San Francisco, California, 94115, United States

Location

Coordinated Health Breast Care Specialists

Allentown, Pennsylvania, 18104, United States

Location

Dallas Surgical Group

Dallas, Texas, 75230, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030-4008, United States

Location

Related Publications (2)

  • Douek M, Klaase J, Monypenny I, Kothari A, Zechmeister K, Brown D, Wyld L, Drew P, Garmo H, Agbaje O, Pankhurst Q, Anninga B, Grootendorst M, Ten Haken B, Hall-Craggs MA, Purushotham A, Pinder S; SentiMAG Trialists Group. Sentinel node biopsy using a magnetic tracer versus standard technique: the SentiMAG Multicentre Trial. Ann Surg Oncol. 2014 Apr;21(4):1237-45. doi: 10.1245/s10434-013-3379-6. Epub 2013 Dec 10.

    PMID: 24322530BACKGROUND

  • Thill M, Kurylcio A, Welter R, van Haasteren V, Grosse B, Berclaz G, Polkowski W, Hauser N. The Central-European SentiMag study: sentinel lymph node biopsy with superparamagnetic iron oxide (SPIO) vs. radioisotope. Breast. 2014 Apr;23(2):175-9. doi: 10.1016/j.breast.2014.01.004. Epub 2014 Jan 29.

    PMID: 24484967BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Technetium Tc 99m Sulfur ColloidRadioisotopes

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sulfur CompoundsInorganic ChemicalsTechnetium CompoundsIsotopes

Results Point of Contact

Title
Clinical Develoment Director
Organization
Endomag
mwomack@endomag.com
+44 7851 247439

Study Officials

  • Michael D Alvarado, MD

    University of CA, San Francisco Carol Franc Buck Breast Care, Dept of Surgery

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2015

First Posted

January 13, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

November 23, 2020

Results First Posted

November 3, 2020

Record last verified: 2020-11

Locations

US(6)