SentiMagIC: SentiMag® Intraoperative Comparison in Breast Cancer

• Sponsor: Endomagnetics Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02336737
• Collaborator: Regulatory and Clinical Research Institute Inc (Other)
• Enrollment: 160
• Locations: 6
• Arm: 1
• Duration (Months): 11
• Patients Per Site: 26.7
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Device: SiennaXP; Drug: Technetium Tc99m Sulfur Colloid; Drug: Isosulfan blue dye	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 160 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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
• Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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; Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe; Drug: Technetium Tc99m Sulfur Colloid; Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid); Other Names: Radioisotope ; Drug: Isosulfan blue dye; Injection of a single dose of isosulfan blue dye; Other Names: Blue dye

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Detected Lymph Nodes [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

2. Safety of SiennaXP and SentiMag® as Indicated by Adverse Events and Serious Adverse Events and Their Relatedness to the Detection Method or Procedure. [3-6 weeks]

   Number of Participants with Adverse Events relating to Sienna XP Injection

Secondary Outcome Measures

1. Nodal Concordance: Number of Nodes Identified by Both Test and Control Out of Nodes Identified by Control [Intraoperative <1 hour]

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

2. Number of Participants With Lymph Nodes Detected by Combined Radioisotope,Blue Dye and Magnetic Technique [Intraoperative <1 hour]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California San Diego Moores Cancer Center	La Jolla	California	United States	92093-0698
2	University of California Davis Comprehensive Cancer Center	Sacramento	California	United States	95817
3	UCSF Carol Franc Buck Breast Care Center	San Francisco	California	United States	94115
4	Coordinated Health Breast Care Specialists	Allentown	Pennsylvania	United States	18104
5	Dallas Surgical Group	Dallas	Texas	United States	75230
6	University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030-4008

Sponsors and Collaborators

• Endomagnetics Inc
• Regulatory and Clinical Research Institute Inc

Investigators

• Principal Investigator: Michael D Alvarado, MD, University of CA, San Francisco Carol Franc Buck Breast Care, Dept of Surgery

Study Documents (Full-Text)

None provided.

More Information

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.
• 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.

• Responsible Party: Endomagnetics Inc
• ClinicalTrials.gov Identifier: NCT02336737
• Other Study ID Numbers: US-001
• First Posted: Jan 13, 2015
• Last Update Posted: Nov 23, 2020
• Last Verified: Nov 1, 2020

• Keywords provided by Endomagnetics Inc: breast cancer; sentinel lymph node biopsy
• Additional relevant MeSH terms: Breast Neoplasms; Technetium Tc 99m Sulfur Colloid

Study Results

Participant Flow

Arm/Group Title	SiennaXP Injection
Arm/Group Description	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. SiennaXP: Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe Technetium Tc99m Sulfur Colloid: Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid) Isosulfan blue dye: Injection of a single dose of isosulfan blue dye
Period Title: Overall Study
STARTED	160
COMPLETED	147
NOT COMPLETED	13

Baseline Characteristics

Arm/Group Title	SiennaXP Injection
Arm/Group Description	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. SiennaXP: Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe Technetium Tc99m Sulfur Colloid: Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid)
Overall Participants	147
Overall Sentinel Lymph Nodes (SLN)	369
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	90 61.2%
>=65 years	57 38.8%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	61.1 (12.3)
Sex: Female, Male (Count of Participants)
Female	147 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	17 11.6%
Not Hispanic or Latino	130 88.4%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	7 4.8%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	11 7.5%
White	121 82.3%
More than one race	0 0%
Unknown or Not Reported	8 5.4%
Region of Enrollment (subjects) [Number]
United States	147

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Detected Lymph Nodes
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SiennaXP Injection
Arm/Group Description	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. SiennaXP: Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe Technetium Tc99m Sulfur Colloid: Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid) Isosulfan blue dye: Injection of a single dose of isosulfan blue dye
Measure Participants	146
Count of Participants [Participants]	145 98.6%

2. Primary Outcome

Title	Safety of SiennaXP and SentiMag® as Indicated by Adverse Events and Serious Adverse Events and Their Relatedness to the Detection Method or Procedure.
Description	Number of Participants with Adverse Events relating to Sienna XP Injection
Time Frame	3-6 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SiennaXP Injection
Arm/Group Description	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. SiennaXP: Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe Technetium Tc99m Sulfur Colloid: Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid) Isosulfan blue dye: Injection of a single dose of isosulfan blue dye
Measure Participants	160
Count of Participants [Participants]	20 13.6%

3. Secondary Outcome

Title	Nodal Concordance: Number of Nodes Identified by Both Test and Control Out of Nodes Identified by Control
Description	The number of nodes identified by both SiennaXP and Control out of nodes identified by Control
Time Frame	Intraoperative <1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SiennaXP Injection
Arm/Group Description	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. SiennaXP: Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe Technetium Tc99m Sulfur Colloid: Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid) Isosulfan blue dye: Injection of a single dose of isosulfan blue dye
Measure Participants	147
Number (95% Confidence Interval) [percentage of concordance]	94.5

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SiennaXP Injection
Arm/Group Description	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. SiennaXP: Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe Technetium Tc99m Sulfur Colloid: Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid)
Measure Participants	146
Count of Participants [Participants]	145 98.6%

Adverse Events

Arm/Group Title	SiennaXP Injection
Arm/Group Description	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. SiennaXP: Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe Technetium Tc99m Sulfur Colloid: Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid) Isosulfan blue dye: Injection of a single dose of isosulfan blue dye
All Cause Mortality
	SiennaXP Injection
	Affected / at Risk (%)	# Events
Total	0/147 (0%)
Serious Adverse Events
	SiennaXP Injection
	Affected / at Risk (%)	# Events
Total	0/147 (0%)
Other (Not Including Serious) Adverse Events
	SiennaXP Injection
	Affected / at Risk (%)	# Events
Total	23/147 (15.6%)
Skin and subcutaneous tissue disorders
Breast discolouration/hyperpigmentation	23/147 (15.6%)	23

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.