Interventional radiologists in the USA received approval to serve as authorised users for Y90 in February 2011. A course organised by the Society of Interventional Radiology from 10–13 February 2011 in Scottsdale, USA, ‘Y90: Are YoU Ready?’ offered a challenging, rigorous curriculum to attendees with testing and demonstrated competency. There was enthusiastic participation from over 106 interventional radiologists. Interventional News found out more from the participants…
The importance of authorised user status
Y90 therapy represents yet another tool we have to treat cancer in the liver. While the idea was not new, the delivery was complicated by side-effects related to non-target delivery, and complications related to surgical approaches to catheterisation. By applying interventional radiology “translational” thinking and advances in catheter/imaging technology and embolization, interventional radiologists have taken what was once an effective but high-risk surgical technique and translated it into a safe and effective outpatient procedure.
Initial prospective series suggest that this therapy should play a central role in the management of both colorectal metastases and primary liver neoplasms. To deliver on this promise, we need to be able to deliver the therapy where the patients live. That means that hundreds, if not thousands, of interventional radiologists need to build on their existing skills and begin to deliver this new therapy.
In the USA, delivery of a therapeutic radioisotope is regulated by the States as well as the national Nuclear Regulatory Commission. The rules that govern who is allowed to order and manage a therapeutic radioisotope are periodically reviewed and updated. Those that applied to Y90 microparticles were written for a time before interventional radiologists assumed such a central role in these procedures and in some centres, the old rules were an impediment—either preventing interventional radiologists from therapy, or impeding efficient patient care.
Since 2000, Riad Salem, professor of Radiology, Oncology and Surgery and director of Interventional Oncology at the Robert H Lurie Comprehensive Cancer Center at Northwestern University recognised the importance of modifying the rules to allow interventional radiologists to serve as authorised users for this specific isotope consistent with our new approach to treatment. “Interventional radiologists were at the forefront of research and development of this new technique. It was only rational that we could obtain authorised user status. I have been an authorised us since 2002,” said Salem.
Salem is a recognised leader in developing and validating interventional radiology’s approach to this therapy. In 2006, he approached the leaders of the American Board of Radiology, the Society of Interventional Radiology (SIR) and other groups to ask them to petition the regulatory agency to add interventional radiologists to the list of Y90 authorised users.
Representing the SIR, he has testified in front of federal agencies several times working towards a regulatory path for interventional radiologists to obtain authorised user status.
Cognisant of the critical importance of ensuring that the treatment is delivered with consistency and expertise, he developed a rigorous 80-hour curriculum, an A to Z of this treatment, which was presented to the committee along with the application.
In mid 2009, the committee entrusted with setting the rules for usership convened in Chicago which included Salem, Brian F Stainken, 2009–2010 president of the Society of Interventional Radiology, Matthew A Mauro, American Board of Radiology trustee and Gary J Becker, executive director of the American Board of Radiology. The proposed rules changes were discussed and a proposal submitted for review suggested that mastery of catheterisation and embolization were central to effective and safe delivery of this isotope.
When combined with existing training in radiation physics and radiation safety, recently trained board certified interventional radiologists could apply for Y90 authorised user status. As a result of these efforts, the changes were published in early February 2011. “This represents a great opportunity, but is also a significant responsibility. Authorised users are responsible for the safe dose calculation and delivery of this potent isotope, as well as the clinical management of patients. “We believe that it is our responsibility to ensure that involved with Y90 should be offered the opportunity to learn ‘from the ground up’ about arterial brachytherapy,” said the participants from the course.
Hence, with the support of key industry leaders, Salem and Stainken joined with Matthew S Johnson, professor of Radiology and Surgery and director of Interventional Oncology, Indiana University School of Medicine to organise this 3.5-day course held 10–13 February. Those who pass the exam will be awarded a certificate from SIR attesting to their accomplishment. This combined with board certification, experience and completion of device specific mentoring as needed, represents a very high standard for competency and proficiency which should suffice to justify endorsement as an authorised user which means that many more interventional radiologists will be offering the treatment and beginning at a much higher level of expertise.
Trends from the meeting
The meeting demonstrated the need to view patients within the entire medical realm, the importance of understanding where Y90 fits into the therapeutic algorithm; understanding the importance of evaluation of a person’s complete medical history and condition as it relates to prognosis following therapy, especially following Y90.
- Some challenges that need to be overcome
- Standardisation of evaluation/technique
- Ensuring the highest level of competence throughout the entire community
- Demystifying radioembolization and its component parts
- Garnering support from the medical oncologic community
- Keeping up with interventional radiologists leading the development of this therapy
An article entitled “Research reporting standards for radioembolization of hepatic malignancies” was published in the March 2011 issue of the Journal of Vascular and Interventional Radiology.