Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
160 participants
INTERVENTIONAL
2015-01-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Regulatory and Clinical Research Institute Inc
OTHER
Endomagnetics Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Michael D Alvarado, MD
Role: PRINCIPAL_INVESTIGATOR
University of CA, San Francisco Carol Franc Buck Breast Care, Dept of Surgery
Locations
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University of California San Diego Moores Cancer Center
La Jolla, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
UCSF Carol Franc Buck Breast Care Center
San Francisco, California, United States
Coordinated Health Breast Care Specialists
Allentown, Pennsylvania, United States
Dallas Surgical Group
Dallas, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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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.
Other Identifiers
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US-001
Identifier Type: -
Identifier Source: org_study_id