Breast Cancer
Conditions
Keywords
breast cancer, sentinel lymph node biopsy
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.
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.
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)
Injection of a single dose of isosulfan blue dye
Sponsors
Regulatory and Clinical Research Institute Inc
Endomagnetics Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 147 |
| 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) | 369 |
| Total | 516 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 8 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | SiennaXP Injection |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 57 Participants |
| Age, Categorical Between 18 and 65 years | 90 Participants |
| Age, Continuous | 61.1 Years STANDARD_DEVIATION 12.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 130 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) White | 121 Participants |
| Region of Enrollment United States | 147 subjects |
| Sex: Female, Male Female | 147 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 147 |
| other Total, other adverse events | 23 / 147 |
| serious Total, serious adverse events | 0 / 147 |
Outcome results
Primary
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
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SiennaXP Injection | Number of Participants With Detected Lymph Nodes | 145 Participants |
Primary
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
Population: Number of subjects experiencing Sienna XP injection-related adverse events from enrollment through subject exit or completion
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SiennaXP 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 Participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SiennaXP Injection | Nodal Concordance: Number of Nodes Identified by Both Test and Control Out of Nodes Identified by Control | 94.5 percentage of concordance |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SiennaXP Injection | Number of Participants With Lymph Nodes Detected by Combined Radioisotope,Blue Dye and Magnetic Technique | 145 Participants |