Breast CancerSentiMagICNCT02336737

SentiMag® Intraoperative Comparison in Breast Cancer

A study testing SiennaXP, Technetium Tc99m Sulfur Colloid and Isosulfan blue dye in people with Breast Cancer, run by Endomagnetics Inc at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Breast Cancer
What is being tested?: SiennaXP, Technetium Tc99m Sulfur Colloid and Isosulfan blue dye
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 6 sitesUnited States
Study dates: Jan 2015to Dec 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Show all 10Show fewer

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.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

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

Other trials in United States

About this study

Official title: A Pivotal, Prospective, Open-Label, Multicenter Paired Comparison Study Of SentiMag/SiennaXP And The Standard Of Care In Patients With Breast Cancer Who Are Undergoing Lymph Node Mapping As Part Of A Sentinel Node Biopsy Procedure

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.

Conditions: Breast Cancer
Being tested: SiennaXP, Technetium Tc99m Sulfur Colloid, Isosulfan blue dye
Keywords: breast cancer, sentinel lymph node biopsy
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SiennaXPDevice
Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe
Technetium Tc99m Sulfur ColloidDrug
Also called Radioisotope
Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid)
Isosulfan blue dyeDrug
Also called Blue dye
Injection of a single dose of isosulfan blue dye

Study groups in NCT02336737
Study group	Role	What they receive
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. Receives: Device: SiennaXP; Drug: Technetium Tc99m Sulfur Colloid; Drug: Isosulfan blue dye

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 3-6 weeks

Secondary outcomes (2)

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
Measured: Intraoperative <1 hour
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)
Measured: Intraoperative <1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Dec 2015

First posted13 Jan 2015 (estimated)
Study startJan 2015
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02336737
Sponsor's protocol ID: US-001
Acronym: SentiMagIC
Status last verified: Nov 2020
First submitted: 7 Jan 2015
Last updated: 23 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pivotal, Prospective, Open-Label, Multicenter Paired Comparison Study Of SentiMag/SiennaXP And The Standard Of Care In Patients With Breast Cancer Who Are Undergoing Lymph Node Mapping As Part Of A Sentinel Node Biopsy Procedure
ClinicalTrials.gov ID: NCT02336737
Acronym / sponsor ID: SentiMagIC / US-001
Conditions: Breast Cancer
Keywords: breast cancer, sentinel lymph node biopsy
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: Endomagnetics IncIndustry (pharma, biotech, devices)
Collaborators: Regulatory and Clinical Research Institute Inc
Study start: Jan 2015
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 13 Jan 2015 (estimated)
Results: Posted 3 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
SiennaXP injection	Experimental	Device: SiennaXP, Drug: Technetium Tc99m Sulfur Colloid, Drug: Isosulfan blue dyeSingle 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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).

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SiennaXPSub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe	Device	SiennaXP injection
Technetium Tc99m Sulfur ColloidAlso: RadioisotopeInjection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid)	Drug	SiennaXP injection
Isosulfan blue dyeAlso: Blue dyeInjection of a single dose of isosulfan blue dye	Drug	SiennaXP injection

Primary outcome

Number of Participants With Detected Lymph Nodes
Time frame: During surgical procedure <1 hour
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
Safety of SiennaXP and SentiMag® as Indicated by Adverse Events and Serious Adverse Events and Their Relatedness to the Detection Method or Procedure.
Time frame: 3-6 weeks
Number of Participants with Adverse Events relating to Sienna XP Injection

2 secondary outcomes

Nodal Concordance: Number of Nodes Identified by Both Test and Control Out of Nodes Identified by Control
Time frame: Intraoperative <1 hour
Number of Participants With Lymph Nodes Detected by Combined Radioisotope,Blue Dye and Magnetic Technique
Time frame: Intraoperative <1 hour

Results and safety

Results posted to the registry on 3 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SiennaXP Injection	160	147

Primary outcome: Number of Participants With Detected Lymph Nodes

Time frame: During surgical procedure <1 hour. Count of participants. Unit: Participants

Measure	SiennaXP Injection n = 146
Value	145

Population analysed: 146/147 were evaluated for the primary objective. One (1) subject had missing data and therefore was not included in the primary endpoint analysis

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

Time frame: 3-6 weeks. Count of participants. Unit: Participants

Measure	SiennaXP Injection n = 160
Value	20

Population analysed: Number of subjects experiencing Sienna XP injection-related adverse events from enrollment through subject exit or completion

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SiennaXP Injection	0 of 147 (0%)	23 of 147 (15.6%)	0 of 147

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24322530Douek 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.
Background: PubMed 24484967Thill 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.

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Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael D Alvarado, MD principal investigator

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

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SiennaXP, Technetium Tc99m Sulfur Colloid and Isosulfan blue dye in people with Breast Cancer, run by Endomagnetics Inc at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Detected Lymph Nodes (time frame: During surgical procedure <1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02336737, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2020.