CClinicalTrials.gg
Sign In
CompletedNCT02336737SentiMagICUpdated Nov 23, 2020Results posted

SentiMag® Intraoperative Comparison in Breast Cancer

An interventional study of SiennaXP and Technetium Tc99m Sulfur Colloid in Breast Cancer, sponsored by Endomagnetics Inc. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-23.

Sponsored by Endomagnetics Inc · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

This is a pivotal, prospective, open label, multicenter, paired comparison of the SentiMag® and SiennaXP® magnetic sentinel node localization system with the standard of care (radioisotope with blue dye) for lymph node localization in the detection of lymph nodes in patients with breast cancer undergoing a sentinel lymph node biopsy. The trial is designed to provide powered evidence that the lymph node detection rate of the SentiMag® and SiennaXP® system is non-inferior to the standard of care in patients with breast cancer.

02

Conditions studied

  • Breast Cancer

Browse trials for

Keywords

  • breast cancer
  • sentinel lymph node biopsy
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 160 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Endomagnetics Inc is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
160 participants (actual)

Study arms

  • Experimental
    SiennaXP injection

    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: SiennaXP · Drug: Technetium Tc99m Sulfur Colloid · Drug: Isosulfan blue dye

Interventions

  • DeviceSiennaXP

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

  • DrugTechnetium Tc99m Sulfur Colloid

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

    Also known as: Radioisotope

  • DrugIsosulfan blue dye

    Injection of a single dose of isosulfan blue dye

    Also known as: Blue dye

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: During surgical procedure <1 hour

  2. 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

    Time frame: 3-6 weeks

Secondary outcomes

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

    The number of nodes identified by both SiennaXP and Control out of nodes identified by Control

    Time frame: Intraoperative <1 hour

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

    The per patient detection rate for a combination of all methods (magnetic, combined radioisotope and blue dye; radioisotope alone; blue dye alone)

    Time frame: Intraoperative <1 hour

07

Results

Posted Nov 3, 2020

Participant flow

Participant flow — Overall Study
MilestoneSiennaXP Injection
Started160
Completed147
Not completed13
Withdrew: Withdrawal by subject5
Withdrew: Physician decision8

Outcome measures

PrimaryNumber 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

Time frame:
During surgical procedure <1 hour
Reported as:
Count of participants · Participants
Number of Participants With Detected Lymph Nodes
ParticipantsSiennaXP Injection
Number of Participants With Detected Lymph Nodes145
PrimarySafety 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

Time frame:
3-6 weeks
Reported as:
Count of participants · Participants
Safety of SiennaXP and SentiMag® as Indicated by Adverse Events and Serious Adverse Events and Their Relatedness to the Detection Method or Procedure.
ParticipantsSiennaXP Injection
Safety of SiennaXP and SentiMag® as Indicated by Adverse Events and Serious Adverse Events and Their Relatedness to the Detection Method or Procedure.20
SecondaryNodal Concordance: Number of Nodes Identified by Both Test and Control Out of Nodes Identified by Control

The number of nodes identified by both SiennaXP and Control out of nodes identified by Control

Time frame:
Intraoperative <1 hour
Reported as:
Number · percentage of concordance
Nodal Concordance: Number of Nodes Identified by Both Test and Control Out of Nodes Identified by Control
percentage of concordanceSiennaXP Injection
Nodal Concordance: Number of Nodes Identified by Both Test and Control Out of Nodes Identified by Control94.5 (92.1 to 96.9)
SecondaryNumber of Participants With Lymph Nodes Detected by Combined Radioisotope,Blue Dye and Magnetic Technique

The per patient detection rate for a combination of all methods (magnetic, combined radioisotope and blue dye; radioisotope alone; blue dye alone)

Time frame:
Intraoperative <1 hour
Reported as:
Count of participants · Participants
Number of Participants With Lymph Nodes Detected by Combined Radioisotope,Blue Dye and Magnetic Technique
ParticipantsSiennaXP Injection
Number of Participants With Lymph Nodes Detected by Combined Radioisotope,Blue Dye and Magnetic Technique145

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SiennaXP Injection0/147 (0%)0/147 (0%)23/147 (15.6%)
Most frequent other events
Most frequent other events
EventSiennaXP Injection
Breast discolouration/hyperpigmentationSkin and subcutaneous tissue disorders23/147

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)SiennaXP Injection
<=18 years0
Between 18 and 65 years90
>=65 years57
Age, Continuous
Age, Continuous(Years)SiennaXP Injection
Mean61.1 ± 12.3
Sex: Female, Male
Sex: Female, Male(Participants)SiennaXP Injection
Female147
Male0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)SiennaXP Injection
Hispanic or Latino17
Not Hispanic or Latino130
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)SiennaXP Injection
American Indian or Alaska Native0
Asian7
Native Hawaiian or Other Pacific Islander0
Black or African American11
White121
More than one race0
Unknown or Not Reported8
Region of Enrollment
Region of Enrollment(subjects)SiennaXP Injection
United States147
08

Study locations

6 sites
  • University of California San Diego Moores Cancer Center
    La Jolla, California 92093-0698, United States
  • University of California Davis Comprehensive Cancer Center
    Sacramento, California 95817, United States
  • UCSF Carol Franc Buck Breast Care Center
    San Francisco, California 94115, United States
  • Coordinated Health Breast Care Specialists
    Allentown, Pennsylvania 18104, United States
  • Dallas Surgical Group
    Dallas, Texas 75230, United States
  • University of Texas MD Anderson Cancer Center
    Houston, Texas 77030-4008, United States
09

References and documents

Publications

  • 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. PubMed 24322530 ↗
  • 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. PubMed 24484967 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02336737
Lead sponsor
Endomagnetics Inc
Collaborators
Regulatory and Clinical Research Institute Inc
Responsible party
Sponsor
First posted
Jan 13, 2015
Start date
Jan 2015
Primary completion
Dec 2015
Completion
Dec 2015
Results posted
Nov 3, 2020
Last update
Nov 23, 2020

Study contacts

Michael D Alvarado, MD
principal investigator · University of CA, San Francisco Carol Franc Buck Breast Care, Dept of Surgery

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Breast Neoplasms→

Other studies from this sponsor

Endomagnetics Inc

Start the discussion