N/A
Completed N=160
SentiMag® Intraoperative Comparison in Breast Cancer
Source: ClinicalTrials.gov NCT02336737 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Number of Participants With Detected Lymph Nodes — 145 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Detected Lymph Nodes |
145 | — |
| PRIMARY Safety of SiennaXP and SentiMag® as Indicated by Adverse Events and Serious Adverse Events and Their Relatedness to the Detection Method or Procedure. |
20 | — |
| SECONDARY Nodal Concordance: Number of Nodes Identified by Both Test and Control Out of Nodes Identified by Control |
94.5 | — |
| SECONDARY Number of Participants With Lymph Nodes Detected by Combined Radioisotope,Blue Dye and Magnetic Technique |
145 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02336737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.