First clinical implementation of Yttrium-90 Disc Brachytherapy after FDA clearance.

PURPOSE: Herein, we study if high-dose-rate (HDR) yttrium-90 (90Y) brachytherapy could be utilized by medical physicists, radiation oncologists, and ophthalmic surgeons. METHODS AND MATERIALS: Yttrium-90 (90Y) beta-emitting brachytherapy sources received United States Food and Drug Administration clearance for episcleral treatment of ocular tumors and benign growths. Dose calibration traceable to the National Institute of Standards and Technology as well as treatment planning and target delineation methods were established. Single-use systems included a 90Y-disc affixed within specialized, multifunction, handheld applicator. Low-dose-rate to high-dose-rate prescription conversions and depth-dose determinations were performed. Radiation safety was evaluated based on live exposure rates during assembly and surgeries. Clinical data for radiation safety, treatment tolerability, and local control was collected. RESULTS: Practice parameters for the medical physicist, radiation oncologist, and ophthalmic surgeon were defined. Device sterilizations, calibrations, assemblies, surgical methods, and disposals were reproducible and effective. Treated tumors included iris melanoma, iridociliary melanoma, choroidal melanoma, and a locally invasive squamous carcinoma. Mean calculated 90Y disc activity was 14.33 mCi (range 8.8-16.6), prescription dose 27.8 Gy (range 22-30), delivered to depth of 2.3 mm (range 1.6-2.6), at treatment durations of 420 s (7.0 min, range 219 s-773 s). Both insertion and removal were performed during one surgical session. After surgery, each disc-applicator- system was contained for decay in storage. Treatments were well-tolerated. CONCLUSIONS: HDR 90Y episcleral brachytherapy devices were created, implementation methods developed, and treatments performed on 6 patients. Treatments were single-surgery, rapid, and well-tolerated with short-term follow up.

The Gap in Insurance Liability for Blood and Research Gamma Irradiators.

ABSTRACT: In 2019, a federal contractor accidently breached a 2,900 Ci 137 Cs sealed source while decommissioning it from a University of Washington research building, releasing a single digit curie of its contents. This event contaminated 13 people as well as all seven floors of the research building, which housed the radiation source. Estimates for clean-up costs and lost revenue exceeded $150 million. The magnitude of this cost prompted licensees in possession of such radioactive sources to question whether their insurance coverage is adequate to cover a large-scale incident and if coverage for such exposure even exists. In this article, we identify potential gaps in commercially available insurance policies by evaluating and assessing associated risks, damages, and accountability. While insurance can mitigate the expense associated with remediation, it is unlikely that sufficient limits would exist to fully protect healthcare institutions from direct financial liability in the event that their radioactive sources are implicated in a nuclear, chemical, biological, or radiological (NCBR) (sometimes called CBRN in other literature) mass contamination event. This paper seeks to outline how the risks and liability to healthcare institutions having such gamma irradiators can be reduced significantly by removing them rather than seeking to insure against the cost of remediation in the event of a leak and/or mass contamination. As such, licensees are encouraged to check their policies for the correct coverage and make sure any coverage restriction is removed from their policies. In addition, licensees are also encouraged to explore financial incentives offered by the US government programs to not only dispose of their present gamma irradiator sources at no cost but also to provide financial support to replace them with alternative technologies.

Clinical Best Practices for Radiation Safety During Lutetium-177 Therapy.

IMPORTANCE: 177 Lu therapy as part of theranostic treatment for cancer is expanding but it can be a challenge for sites with limited radiation protection staff to implement the radiation safety program required for therapeutic nuclear medicine. OBJECTIVE: To increase the adoption of 177 Lu therapy, especially in smaller centers and clinics, by providing a collection of radiation safety best practices and operational experience. To provide a resource for radiation safety officers supporting the implementation of a 177 Lu therapy program. METHODS: A panel of 11 radiation safety professionals representing sites across Canada and the United States with experience delivering 177 Lu therapy was assembled and discussed their responses to a list of questions focused on the following radiation safety topics: facility layout and design; radiation safety program; and drug management and patient care. RESULTS: A comprehensive set of best practice guidelines for clinical radiation safety during 177 Lu therapy has been developed based on the collective operational experience of a group of radiation safety professionals. Significant findings included that 177 Lu therapy is often safely administered in unshielded rooms, that staff radiation exposure associated with 177 Lu therapy is minimal relative to other nuclear medicine programs, and that some relatively simple preparation in advance including papering of common surfaces and planning for incontinence can effectively control contamination during therapy. CONCLUSION: The guidance contained in this paper will assist radiation safety professionals in the implementation of safe, effective 177 Lu therapy programs, even at smaller sites with limited to no experience in therapeutic nuclear medicine.

Deciding between an X-Ray and 137Cs Irradiator - It's not just about Energy Spectra.

Irradiators utilizing radioactive cesium-137 (137Cs) or cobalt-60 (60Co) gamma-ray sources have been used for biological applications for many decades. These applications include irradiation of much of the nation's blood supply and radiation biology research. In 2005, the U.S. Nuclear Regulatory Commission was assigned the task of preventing the misuse of radioactive materials by persons with malicious intentions; gamma-ray sources, in particular, were given high priority. This resulted in increased security requirements, including constant surveillance, controlled access and personnel background checks. As a result of such regulations being introduced, organizations considering the purchase of a gamma-ray irradiator for the first time or as a replacement to an existing one due to radioactive decay, are now looking into alternative technologies, primarily an X-ray irradiator. To make an educated decision on whether a particular type of X-ray irradiator is of sufficient equivalency to a particular type of 137Cs irradiator for specific applications, one must rely on relevant published comparison studies from other researchers, or perform the comparison studies on their own. This work focuses on the comparison of the radiation physics aspects of two 137Cs irradiator models and three X-ray irradiator models, for the purpose of determining whether the X-ray irradiator models could validly replace the 137Cs irradiator models for certain applications. Although evaluating the influence of relative biological effectiveness (RBE) differences among irradiators could be part of this study, that has been left for a related publication focused on the theoretical aspects of this topic. These evaluations were performed utilizing 47-g and 120-g tissue-equivalent rodent dosimetry phantoms. Our results indicate that, depending upon the user's dose uncertainty budget and maximum areal density of specimens to be irradiated, the RS 2000 160 kVp X-ray irradiator, X-RAD160 X-ray irradiator or X-RAD320 X-ray irradiator could successfully replace a 137Cs irradiator. Technically, any X-ray irradiator model providing similar irradiation geometry, and average energy similar to or higher than these three X-ray models, could also successfully replace a 137Cs irradiator. The results also reveal that differences in inherent source geometry, field geometry and irradiation geometry can counter some of the influence due to differences in energy spectrum. Our goal is that this publication be used as a guide for other similar studies, providing investigators with information on important details that can make the difference between strong and weak comparison conclusions.

Successful Migration from Radioactive Irradiators to X-ray Irradiators in One of the Largest Medical Centers in the US.

This paper summarizes about 9 years of effort by Mount Sinai to successfully migrate completely from radioactive irradiators to x-ray irradiators without compromising patient care or research studies. All the effort by Mount Sinai to permanently remove the risk of malicious use of radioactive materials as Radiological Dispersal Device or dirty bomb is reviewed. Due to the unique characteristics of the cesium chloride (CsCl) used in irradiators, it is especially susceptible to be used as a dirty bombs. Mount Sinai originally had four of such irradiators. To reduce and eventually remove the risk of malicious use of radioactive materials, Mount Sinai in New York City has taken several steps. One of such measures was to harden the radioactive irradiators to make the radioactive materials harder to be stolen for malicious purposes. By increasing the delay time, the local law enforcement agency (LLEA) will have more time to stop the intruder. Another measure taken was to implement enhanced security in facilities having radioactive materials. We collaborated with the National Nuclear Security Administration and used state-of-the-art security equipment such as Biometric Access Control and 24/7 video monitoring. In addition, a remote monitoring system with alarms was installed and connected to LLEA for constant monitoring and possible intervention, if necessary, in a timely manner. The other measure taken was to limit the number of people who have access to such radioactive materials. We adopted a single person operator method and reduced the number of people having access from 145 people to only a few people. The adoption of such measures has reduced the risk significantly; however, the best way to remove the permanent risk of these radioactive materials that may be used for a dirty bomb is to use alternative technology to replace these high-activity radioactive sources. In 2013, Mount Sinai purchased its first x-ray irradiator to investigate the feasibility of using x-ray irradiators instead of cesium irradiators for research purposes for cells and small mice. The results from comparison studies were promising, which led to the decision of permanent migration of all cesium irradiators to x-ray irradiators. As of January 2018, Mount Sinai successfully disposed all its Cs irradiators. At this time, Mount Sinai, as one of the largest health care institutions in NY with about 50,000 employees, has migrated completely to alternative technology and removed the risk of malicious use of radioactive materials permanently.

Reduction in occupational and patient radiation exposure from myocardial perfusion imaging: impact of stress-only imaging and high-efficiency SPECT camera technology.

UNLABELLED: Recently introduced high-efficiency SPECT cameras have demonstrated the ability to reduce radiation exposure to patients undergoing myocardial perfusion imaging studies, especially when combined with stress-only imaging protocols. To date there have been no relevant studies examining the reduced occupational radiation exposure to medical staff. We sought to determine whether changes in stress myocardial perfusion imaging protocols and camera technology can reduce the occupational radiation exposure to the staff of a nuclear cardiology laboratory. METHODS: Monthly radiation dosimeter readings from 4 nuclear technologists, 4 nurses, and 2 administrative employees were analyzed from two 12-mo periods: October 2007-September 2008 (period 1), before the use of high-efficiency SPECT, and October 2010-September 2011 (period 2), after high-efficiency SPECT was introduced. The average monthly dose equivalent in millirems (1 mrem = 0.01 mSv) was recorded from personal dosimeters worn on laboratory coats. The total activity of (99m)Tc used per month, mean (99m)Tc administered activity per patient, average number of patients per month, patient time spent in the laboratory, and proportion of stress-only studies were determined. RESULTS: There were 3,539 patients in period 1 and 3,898 in period 2. An approximately 40% reduction in the dose equivalent across all staff members occurred during this time (-16.9 and -16.2 mrem for nuclear technologists and nurses, respectively; P < 0.0001). During period 2, the total activity of (99m)Tc used per month decreased (10,746 vs. 7,174 mCi [1 mCi = 37 MBq], P < 0.0001), as did the mean (99m)Tc administered activity per patient (36.5 vs. 23.8 mCi, P < 0.0001). The percentage of patients having stress-only imaging increased (35% vs. 56%, P < 0.0001), and the total patient time spent in the laboratory decreased. Radiation dose equivalent levels were reduced in period 2 to 1%-7% of the allowed annual occupational dose equivalent. The combination of the use of high-efficiency SPECT technology and stress-only protocols resulted in a 34.7% reduction in mean total (99m)Tc administered activity between time periods, with camera technology being responsible for 39.2% of the reduction and stress-only protocols for 60.8%. CONCLUSION: A combination of high-efficiency SPECT technology and selective use of stress-only protocols significantly reduces the occupational radiation dose equivalent to the staff of a nuclear cardiology laboratory.