Why Magseed users should enrol in the MELODY study - Q&A with Prof. Banys-Paluchowski
The EUBREAST MELODY study is open for recruitment, with the aim to analyse how wire-free markers like the Magseed® marker could outperform the traditional guidewire method.
With data from over 11,000+ patients already published in clinical studies, including the very first iBRA-NET localisation study, we’ve never been afraid to put Magseed under the microscope.
So to find out more about MELODY, we sat down with Principle Investigator, Prof. Maggie Banys-Paluchowski, to discuss the motivations behind the study, and how centres using Magseed can take part.
Plus, she shares her views on why there remains a need for independent randomised studies, and how the tide seems to be turning particularly in favour of data-supported wire-free devices, as shown by the recent AGO ‘+’ rating for Magseed.
Q. Could you tell us about the motivation behind the MELODY study
A. The aim of the MELODY Study is to compare all of commercially available localization techniques at once and see how they perform against the guidewire.
We know the traditional guide-wire, the oldest form of localization, has multiple disadvantages for both the patient and surgeon and this is why new localization techniques, like the Magseed, have been developed.
As a prospective, non-interventional, multicenter cohort study, we wanted to evaluate these different imaging–guided methods for localizing malignant breast lesions and see how they perform, without any bias or industry influence.
Q. What are the main endpoints you’ll be assessing?
A. We have two primary endpoints. Firstly, does the technology work? Are we able to accurately remove the target lesion using a specific localization technique?
And secondly, how are the margins? Are they similar in all cohorts or do we see differences?
Q. What do you hope the study will achieve?
A. I really hope that we will establish that probe guided detection techniques are non-inferior to wire guidance so surgeons and radiologists are free to use the technique that suits them best.
I am very interested to look at the patient, surgeon and radiologist satisfaction. As we’ve seen with the MagTotal trial, led by Dr. Andreas Karakatsanis, it revealed that probe guided techniques may be more satisfactory for all those involved.
So this is an aspect that is very, very important for us. I would hope that after the study, we will know which technique is best for which patient.
Q. What is the current status of recruitment for the study?
A. In total we hope to accrue a representative sample of around 7,500 patients. At the moment we have 1,400 patients enrolled into the study and the recruitment curve is rapidly going up. This includes 99 open study sites across 17 countries.
We know from our experience with the AXSANA Study that it can take time to open up study sites, especially in new countries.
We’ve found that once one study site is open and running in a new country, usually the others follow quite quickly because they already have that first ethical approval to reference.
→ A full list of participating sites can be found on the EUBREAST website.
Q. How can hospitals get involved in the study?
A. The easiest way to get involved in MELODY is to contact the Head of the National Steering Committee for your country. These surgeons will be the lead for your country and will coordinate opening each new study site.
If you see that there is no national steering committee established in your country, please contact EUBREAST directly, and we can discuss your next steps.
For those who haven’t had the chance to work with iBRA-NET and EUBREAST in the past, it really is a wonderful opportunity to strengthen international partnerships and network with leading physicians across the world.
Q. What impact could the results have on an international level?
A. We have seen first hand in Germany the impact robust study data can have with the recent AGO ‘+’ rating of the Magseed, the first wire-free marker to achieve this rating.
However, we hope that the data from MELODY will be used to make further marker recommendations and potentially influence future guidelines to upgrade techniques beyond Germany, and across the world.
We hope that as MELODY is a multicentre, randomized, prospective study we will remove bias and produce reliable results to inform the future of breast cancer surgery for years to come.