Clinical trial NCT02336737: SentiMag® Intraoperative Comparison in Breast Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
sentinel lymph node biopsy
Lead sponsor: Endomagnetics Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Regulatory and Clinical Research Institute Inc
First posted: 2015-01-13
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Detected Lymph Nodes
timeFrame: During surgical procedure <1 hour
measure: Safety of SiennaXP and SentiMag® as Indicated by Adverse Events and Serious Adverse Events and Their Relatedness to the Detection Method or Procedure.
timeFrame: 3-6 weeks
Secondary outcomes:
measure: Nodal Concordance: Number of Nodes Identified by Both Test and Control Out of Nodes Identified by Control
timeFrame: Intraoperative <1 hour
measure: Number of Participants With Lymph Nodes Detected by Combined Radioisotope,Blue Dye and Magnetic Technique
timeFrame: Intraoperative <1 hour
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego Moores Cancer Center
state: California
city: Sacramento
country: United States
facility: University of California Davis Comprehensive Cancer Center
state: California
city: San Francisco
country: United States
facility: UCSF Carol Franc Buck Breast Care Center
state: California
city: Allentown
country: United States
facility: Coordinated Health Breast Care Specialists
state: Pennsylvania
city: Dallas
country: United States
facility: Dallas Surgical Group
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: University of CA, San Francisco Carol Franc Buck Breast Care, Dept of Surgery
name: Michael D Alvarado, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.