Clinical data

The Magtrace® lymphatic tracer has been clinically proven to be a safe and effective treatment

Since its earliest use, the Magtrace® lymphatic tracer 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® lymphatic tracer compares to alternative technologies.

Meta-analysis which shows how the Magtrace® lymphatic tracer is superior to blue dye alone and comparable to dual tracer.

Key points

  • Includes data from 35 studies from across the world
  • The Magtrace® lymphatic tracer is superior to blue dye alone, and comparable to the standard dual-modality technique of blue dye with Tc

Meta-analysis demonstrating how Magtrace® lymphatic tracer is non-inferior to standard Tc99, with or without Blue dye

Key points

  • Unlike blue dye, which reported cases of anaphylaxis, no significant adverse effects were recorded for the Magtrace® lymphatic tracer

Meta-analysis showing Magtrace® lymphatic tracer is non-inferior to Tc99 and blue dye

Key points

  • SN detection rates were 96.8% for standard technique versus 97.1% for the Magtrace® lymphatic tracer
  • All seven studies favour the Magtrace® lymphatic tracer for successful retrieval of lymph nodes against standard technique – average of 1.9 per patient vs 1.8 respectively
  • The Magtrace® lymphatic tracer reports significantly lower false negative rates to the standard technique

A study showing Magnetic SLNB can be performed easily, safely and equivalently well in comparison to radioisotope alone

Key points

  • Nodal detection rate for the Magtrace® lymphatic tracer was significantly higher (97.3%) than the radioisotope (91.8%)

A study showing that Magtrace® lymphatic tracer is non-inferior to Tc99 and offers both cost and availability benefits to radioisotope

Key points

  • The nodal detection rate was higher for the Magtrace® lymphatic tracer
  • It has the benefit of reducing hospital costs with more flexible scheduling

A study showing that Magtrace® lymphatic tracer is non-inferior to radiotracer and is oncologically safe

Key points

  • A superior rate of detection was noted with the Magtrace® lymphatic tracer (98.3%) vs radioisotope (95.7%)
  • The Magtrace® lymphatic tracer obtained 2.2 nodes on average per patient, compared to 1.9 for radioisotope

This study shows that the Magtrace® lymphatic tracer is a feasible technique for SLNB with detection rates non-inferior to standard technique

Key points

  • High detection rate of 95% and average lymph node retrieval rate of 2 nodes per patient
  • The magnetic technique has significant advantages in that it can replace the need for blue dye and can be visualised on MRI

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

Key points

  • Magtrace® lymphatic tracer 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® lymphatic tracer was 2.4
  • The Magtrace® lymphatic tracer offers greater scheduling flexibility

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

Key points

  • Five clinical trials were included, with 1,683 SLN’s in 804 patients
  • Magtrace® lymphatic tracer demonstrated statistical non-inferiority with standard tracers
  • No anaphylaxis associated with the Magtrace® lymphatic tracer

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

Summary

A Meta-analysis showing Magtrace® lymphatic tracer 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® lymphatic tracer
  • The Magtrace® lymphatic tracer was comparable to the standard techniques and also simplifies logistics
  • The technique was easily adopted amongst surgeons experienced with the SLNB technique

A safety study showing the Magtrace® lymphatic tracer 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® lymphatic tracer injection was noted in 15.5% of patients
  • Discolouration reduced to 3.6% of patients at 30 months

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

Key points

  • Magtrace® lymphatic tracer results were non-inferior to those of the standard dual technique
  • The use of the Magtrace® lymphatic tracer can simplify logistics and improve performance, e.g. adding the potential to inject the Magtrace® lymphatic tracer days before the operation

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

Key points

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

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

Key points

  • No Magseed® marker migration was noted and low tumour resection volumes were documented (CRR - 1.49)
  • Peritumoral injection of the Magtrace® lymphatic tracer 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 the Magseed® marker and Magtrace® lymphatic tracer for lesion localisation and SLNB

Key points

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

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

Key points

  • 78.3% of patients were able to avoid an unnecessary SLNB
  • All delayed SLNBs were successful
  • Costs were reduced by 24.5% in women without IBC

A feasibility study showing the Magtrace® lymphatic tracer 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® lymphatic tracer for pre-operative localization of SLN’s and its potential for non-invasive identification of lymph node metastases

Key points

  • Magtrace® lymphatic tracer MRI successfully identified SLNs in 10 of 11 patients
  • Magtrace® lymphatic tracer 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® lymphatic tracer for lesion localisation combined with periareolar injection of blue dye for SLNB

Key points

  • Intratumoral injection of Magtrace® lymphatic tracer was done pre-operatively
  • SLNB was successful with Magtrace® lymphatic tracer plus blue dye equivalent to the standard technique
  • Magtrace® lymphatic tracer 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® lymphatic tracer and its safety, effectiveness and clinical results, please get in touch and we will be happy to assist you.