Clinical trial · Interventional
SentiMag® Intraoperative Comparison in Breast Cancer
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
NCT02336737CI-TRIAL-00048433SentiMagICcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Isosulfan blue dye | Drug | — | UNRESOLVED |
| SiennaXP | Device | — | UNRESOLVED |
| Technetium Tc99m Sulfur Colloid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SiennaXP injection
- description
- 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.
- interventionNames
- Device: SiennaXP
- Drug: Technetium Tc99m Sulfur Colloid
- Drug: Isosulfan blue dye
Primary outcomes (2)
- measure
- Number of Participants With Detected Lymph Nodes
- timeFrame
- During surgical procedure <1 hour
- description
- 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
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDDouek 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. PMID 24322530
- BACKGROUNDThill 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. PMID 24484967