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| Name | Class |
|---|---|
| Regulatory and Clinical Research Institute Inc | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SiennaXP | Device | Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 3-6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Intraoperative <1 hour |
| Number of Participants With Lymph Nodes Detected by Combined Radioisotope,Blue Dye and Magnetic Technique |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael D Alvarado, MD | University of CA, San Francisco Carol Franc Buck Breast Care, Dept of Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego Moores Cancer Center | La Jolla | California | 92093-0698 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24322530 | Background | 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. | |
| 24484967 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 146/147 were evaluated for the primary objective. One (1) subject had missing data and therefore was not included in the primary endpoint analysis | Posted | Count of Participants | Participants | During surgical procedure <1 hour |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast discolouration/hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Develoment Director | Endomag | +44 7851 247439 | mwomack@endomag.com |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D013671 | Technetium Tc 99m Sulfur Colloid |
| D011868 | Radioisotopes |
| ID | Term |
|---|---|
| D013457 | Sulfur Compounds |
| D007287 | Inorganic Chemicals |
| D017556 | Technetium Compounds |
| D007554 | Isotopes |
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| Technetium Tc99m Sulfur Colloid | Drug | Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid) |
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| Isosulfan blue dye | Drug | Injection of a single dose of isosulfan blue dye |
|
|
The per patient detection rate for a combination of all methods (magnetic, combined radioisotope and blue dye; radioisotope alone; blue dye alone) |
| Intraoperative <1 hour |
| 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 |
| Background |
| 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. |
| Sentinel Lymph Nodes (SLN) |
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| Participants |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | Years | Participants |
|
| Sex: Female, Male | Sex of study subject was recorded | Count of Participants | Participants | Participants |
|
| Ethnicity (NIH/OMB) | Study subjects self-reported their ethnicity | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Study subjects self reported their race | Count of Participants | Participants | Participants |
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| Region of Enrollment | Country where study was being conducted | Number | subjects | Participants |
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| 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 | Number of subjects experiencing Sienna XP injection-related adverse events from enrollment through subject exit or completion | Posted | Count of Participants | Participants | 3-6 weeks |
|
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| 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 | Posted | Number | 95% Confidence Interval | percentage of concordance | Intraoperative <1 hour |
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| 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) | Posted | Count of Participants | Participants | Intraoperative <1 hour |
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| 0 |
| 147 |
| 0 |
| 147 |
| 23 |
| 147 |
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| D017437 |
| Skin and Connective Tissue Diseases |