Clinical data

The Magtrace® node marker has been clinically proven to be a safe and effective treatment

Since its earliest use, the Magtrace® node marker has been subject to numerous regulatory approvals, clinical studies and peer-review papers.

Here you can read the clinical assessments in full and see how the Magtrace® node marker compares to alternative technologies.

This study shows that the Magtrace® node marker is a feasible technique for SLNB with detection rates non-inferior to standard technique and logistical advantages

Key points

  • The identification rate was 95.0% (152 of 160) with the standard technique and 94.4% (151 of 160) with the magnetic technique (0.6% difference; 95% upper confidence limit 4.4%; 6.9% discordance)
  • The lymph node retrieval rate was 1.9 nodes per patient with the standard technique, and 2.0 nodes per patient with the magnetic technique.
  • The magnetic technique has significant advantages in that it can replace the need for blue dye and can be visualised on MRI
  • This trial is practice-changing for those surgeons who are still using blue dye alone for SLNB

This US based multi-centre prospective study finds the Magtrace® node marker is non-inferior to the standard technique for SLNB

Summary

The Magtrace® node marker is non-inferior to the standard technique of radioisotope and blue dye for axillary SLN detection in early-stage breast cancer.

Key points

  • Magtrace® node marker per patient detection rate was 99.3%, the dual technique per patient detection rate was 98.6%
  • Average number of nodes detected per patient with the Magtrace® node marker was 2.4
  • 43.5% of patients received their radioisotope injection in a separate building, 31.3% of these were driving distance. This can be avoided by intraoperative injection with the Magtrace® node marker.
  • The Magtrace® node marker offers greater scheduling flexibility

This study shows that the Magtrace® node marker is a valuable alternative to radioisotope and blue dye

Summary

A Meta-analysis that concludes the Magtrace® node marker is non-inferior to standard Tc99 with or without blue dye.

Key points

  • Five clinical trials were included in the meta-analysis, with 1683 SLN’s in 804 patients
  • Magtrace® node marker demonstrated statistical non-inferiority with standard tracers
  • No anaphylaxis associated with the Magtrace® node marker

This study shows that the Magtrace® node marker is a safe and effective alternative to the standard technique

Summary

A Meta-analysis showing Magtrace® node marker non-inferiority versus ‘conventional techniques’ for SLNB in addition to reporting on a multicentre prospective trial

Key points

  • SN detection rates were 97.1% for standard technique and 97.6% for the Magtrace® node marker
  • The Magtrace® node marker was comparable to the standard techniques and also simplifies logistics
  • The technique was easily adopted amongst surgeons experienced with the SLNB technique

This study shows that the magnetic technique for SLNB is non-inferior to the standard technique, with a high identification rate and a significantly higher lymph node retrieval rate

Summary

Meta-analysis showing SPIO is non-inferior to the standard technique with a significantly higher node retrieval rate

Key points

  • False Negative Rates were calculated at 10.9% for standard technique and 8.4% for the magnetic technique
  • Total lymph node retrieval rate was slightly higher with the magnetic compared to the standard technique (1.9 nodes versus 1.8 nodes)

The MONOS study evaluates the use of the Magtrace® node marker as the sole tracer used in SLNB

Key points

  • Magtrace® node marker results were comparable to those of the standard dual technique
  • The use of the Magtrace® node marker can simplify logistics and improve performance, e.g. adding the potential to inject the Magtrace® node marker days before the operation

The largest cohort of the Magtrace® node marker-only application for SLNB, providing simpler logistics and operative planning with excellent clinical results

Key points

  • The largest cohort of Magtrace® node marker-only use for SLNB, in an Asian population
  • The Magtrace® node marker provided a 98.8% per patient detection rate
  • On site savings of $22,300 per year when using the Magtrace® node marker compared to a radiotracer

A study demonstrating accurate lesion localisation and SLN detection with the combined use of the Magseed® and Magtrace® markers

Key points

  • No Magseed® marker migration was noted and low tumour resection volumes were documented (CRR - 1.49)
  • Peritumoral injection of the Magtrace® node marker was utilised and all SLNB’s were successful
  • Clinicians reported the method was easier than hook-wire localisation
  • Hospital scheduling was improved

A study showing the combined use of Magseed and Magtrace for lesion localisation and SLNB

Key points

  • All lesions were successfully excised with tumour-free margins
  • SLNB was successful in all patients
  • The Magtrace® node marker was injected subareolar pre or post operatively
  • No interference between the Magseed® and Magtrace® marker signals was noted

A safety study showing the Magtrace® node marker to be safe with a low risk of complications

Summary

The Sentimag® probe is a safe SLN identification method and has a low risk of complications

Key points

  • Significant correlation was noted between number of nodes resected and post-operative complications
  • Discoloration due to Magtrace® node marker injection was noted in 15.5% of patients
  • Discolouration reduced to 3.6% of patients at 30 months

This study shows that the Magtrace® node marker spared DCIS patients the need for unnecessary SLNB by enabling a delayed SLNB technique

Summary

78.3% of patients were able to avoid an unnecessary SLNB.

Key points

  • Magtrace® node marker plus blue dye outperformed isotope plus blue dye
  • All delayed SLNBs were successful
  • Costs were reduced by 24.5% in women without IBC

A feasibility study showing the Magtrace® node marker as a contrast agent in MRI to provide pre-op imaging localisation of sentinel lymph nodes

Summary

This study evaluates the feasibility of using MRI following the administration of the Magtrace® node marker for pre-operative localization of SLN’s and its potential for non-invasive identification of lymph node metastases

Key points

  • Magtrace® node marker MRI successfully identified SLNs in 10 of 11 patients
  • Magtrace® node marker MRI is a feasible technique for pre-operative localisation of SLNs and, in combination with the Sentimag® probe, provides an entirely radioisotope-free technique for SLNB

A study showing the feasibility of the Magtrace® node marker for lesion localisation combined with periareolar injection of blue dye for SLNB

Key points

  • Intratumoral injection of Magtrace® node marker was done pre-operatively
  • SLNB was successful with Magtrace® node marker plus blue dye equivalent to the standard technique
  • Magtrace® node marker lesion localisation in a SNOLL type procedure is feasible and also enables SLNB

Additional references

If you would like to read additional literature relating to the Magtrace® node marker and its safety, effectiveness and clinical results, please get in touch and we will be happy to assist you.