Trial Outcomes & Findings for SentiMag® Intraoperative Comparison in Breast Cancer (NCT NCT02336737)

Last Updated: 2020-11-23

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

160 participants

Primary outcome timeframe

During surgical procedure <1 hour

Results posted on

2020-11-23

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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
Overall Study STARTED	160
Overall Study COMPLETED	147
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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
Overall Study Withdrawal by Subject	5
Overall Study Physician Decision	8

Baseline Characteristics

SentiMag® Intraoperative Comparison in Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SiennaXP Injection n=369 Sentinel Lymph Nodes (SLN) 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)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	90 Participants n=5 Participants
Age, Categorical >=65 years	57 Participants n=5 Participants
Age, Continuous	61.1 Years STANDARD_DEVIATION 12.3 • n=5 Participants
Sex: Female, Male Female	147 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	130 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants
Race (NIH/OMB) White	121 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants
Region of Enrollment United States	147 subjects n=5 Participants

PRIMARY outcome

Timeframe: During surgical procedure <1 hour

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

Outcome measures

Outcome measures
Measure	SiennaXP Injection n=146 Participants 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
Number of Participants With Detected Lymph Nodes	145 Participants

PRIMARY outcome

Timeframe: 3-6 weeks

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

Number of Participants with Adverse Events relating to Sienna XP Injection

Outcome measures

Outcome measures
Measure	SiennaXP Injection n=160 Participants 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
Safety of SiennaXP and SentiMag® as Indicated by Adverse Events and Serious Adverse Events and Their Relatedness to the Detection Method or Procedure.	20 Participants

SECONDARY outcome

Timeframe: Intraoperative <1 hour

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

Outcome measures

Outcome measures
Measure	SiennaXP Injection n=147 Participants 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
Nodal Concordance: Number of Nodes Identified by Both Test and Control Out of Nodes Identified by Control	94.5 percentage of concordance Interval 92.1 to 96.9

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	SiennaXP Injection n=146 Participants 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
Number of Participants With Lymph Nodes Detected by Combined Radioisotope,Blue Dye and Magnetic Technique	145 Participants

Adverse Events

SiennaXP Injection

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	SiennaXP Injection n=147 participants at risk 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
Skin and subcutaneous tissue disorders Breast discolouration/hyperpigmentation	15.6% 23/147 • Number of events 23

Additional Information

Clinical Develoment Director

Endomag

Phone: +44 7851 247439

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place