Logistical, technical, and radiation safety aspects of establishing a radiopharmaceutical therapy program: A case in Lutetium‐177 prostate‐specific membrane antigen (PSMA) therapy

Zoberi, Jacqueline E.; Garcia-Ramirez, José; Luechtefeld, David; Maughan, Nichole M.; Amurao, Maxwell; Oyama, Reiko; Baumann, Brian C.; Gay, Hiram A.; Michalski, Jeff M.

doi:10.1002/acm2.13899

Cited by 4 publications

(1 citation statement)

References 26 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Zoberi et al. present a comprehensive account of using a syringe method to dispense Pluvicto ( 41 ). The staff should receive proper training to prevent contamination or spillage when administering Pluvicto via syringe.…”

Section: Discussionmentioning

confidence: 99%

A single-institution experience with 177Lu RPT workflow improvements and qualifying the SPECT/CT imaging for dosimetry

George,

Tolakanahalli,

Aguirre

et al. 2024

Front. Oncol.

View full text Add to dashboard Cite

Background and purposeImplementing any radiopharmaceutical therapy (RPT) program requires a comprehensive review of system readiness, appropriate workflows, and training to ensure safe and efficient treatment delivery. A quantitative assessment of the dose delivered to targets and organs at risk (OAR) using RPT is possible by correlating the absorbed doses with the delivered radioactivity. Integrating dosimetry into an established RPT program demands a thorough analysis of the necessary components and system fine-tuning. This study aims to report an optimized workflow for molecular radiation therapy using 177Lu with a primary focus on integrating patient-specific dosimetry into an established radiopharmaceutical program in a radiation oncology setting.Materials and methodsWe comprehensively reviewed using the Plan–Do–Check–Act (PDCA) cycle, including efficacy and accuracy of delivery and all aspects of radiation safety of the RPT program. The GE Discovery SPECT/CT 670DR™ system was calibrated per MIM protocol for dose calculation on MIM SurePlan™ MRT software. Jaszcak Phantom with 15–20 mCi of 177Lu DOTATATE with 2.5 µM EDTA solution was used, with the main energy window defined as 208 keV ±10% (187.6 to 229.2 keV); the upper scatter energy window was set to 240 keV ±5% (228 to 252 keV), while the lower scatter energy window was 177.8 keV ±5% (168.9 to 186.7 keV). Volumetric quality control tests and adjustments were performed to ensure the correct alignment of the table, NM, and CT gantry on SPECT/CT. A comprehensive end-to-end (E2E) test was performed to ensure workflow, functionality, and quantitative dose accuracy.ResultsWorkflow improvements and checklists are presented after systematically analyzing over 400 administrations of 177Lu-based RPT. Injected activity to each sphere in the NEMA Phantom scan was quantified, and the MIM Sureplan MRT reconstruction images calculated activities within ±12% of the injected activity. Image alignment tests on the SPECT/CT showed a discrepancy of more than the maximum tolerance of 2.2 mm on any individual axis. As a result of servicing the machine and updating the VQC and COR corrections, the hybrid imaging system was adjusted to achieve an accuracy of <1 mm in all directions.ConclusionWorkflows and checklists, after analysis of system readiness and adequate training for staff and patients, are presented. Hardware and software components for patient-specific dosimetry are presented with a focus on hybrid image registration and correcting any errors that affect dosimetric quantification calculation. Moreover, this manuscript briefly overviews the necessary quality assurance requirements for converting diagnostic images into dosimetry measurement tools and integrating dosimetry for RPT based on 177Lu.

show abstract

Section: Discussionmentioning

confidence: 99%

A single-institution experience with 177Lu RPT workflow improvements and qualifying the SPECT/CT imaging for dosimetry

George,

Tolakanahalli,

Aguirre

et al. 2024

Front. Oncol.

View full text Add to dashboard Cite

show abstract

Logistical, technical, and radiation safety aspects of establishing a radiopharmaceutical therapy program: A case in Lutetium‐177 prostate‐specific membrane antigen (PSMA) therapy

Zoberi

Garcia-Ramirez

Luechtefeld

et al. 2023

J Applied Clin Med Phys

View full text Add to dashboard Cite

Prostate‐specific membrane antigen (PSMA) is a cell surface protein highly expressed in nearly all prostate cancers, with restricted expression in some normal tissues. The differential expression of PSMA from tumor to non‐tumor tissue has resulted in the investigation of numerous targeting strategies for therapy of patients with metastatic prostate cancer. In March of 2022, the FDA granted approval for the use of lutetium‐177 PSMA‐617 (Lu‐177‐PSMA‐617) for patients with PSMA‐positive metastatic castration‐resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibition and taxane‐based chemotherapy. Therefore, the use of Lu‐177‐PSMA‐617 is expected to increase and become more widespread. Herein, we describe logistical, technical, and radiation safety considerations for implementing a radiopharmaceutical therapy program, with particular focus on the development of operating procedures for therapeutic administrations. Major steps for a center in the U.S. to implement a new radiopharmaceutical therapy (RPT) program are listed below, and then demonstrated in greater detail via examples for Lu‐177‐PSMA‐617 therapy.

show abstract

Enhancing safety: Multi‐institutional FMEA and FTA on 177Lu$^{177}{\rm Lu}$‐based radio‐pharmaceutical therapy

George,

Aguirre,

Maughan

et al. 2024

J Applied Clin Med Phys

View full text Add to dashboard Cite

PurposeThis study investigates potential failure modes and conducts failure mode and effects analysis (FMEA) and fault tree analysis (FTA) on the administration of DOTATATE (LUTATHERA) and PSMA‐617 (PLUVICTO). The quality management (QM) process in radiopharmaceutical therapies (RPTs) requires collaboration between nuclear medicine (NM) and radiation oncology (RO) departments. As part of a multi‐institutional study, we surveyed various departments to identify and analyze failure modes, leading to a proposed comprehensive QM program. RPT teams in RO or NM clinics can benefit from this study by continually improving their practice.MethodsWe reviewed the literature to investigate the administration of Pluvicto and Lutathera, focusing on prospective procedural failures and potential failure modes (PFMs) and their outcomes. We distributed an FMEA survey to multiple experienced centers in ‐based RPTs and calculated risk priority number (RPN) for various PFM. We conducted an FTA using this information to pinpoint the root causes of potential failures.ResultsThe findings from the literature review and survey responses on the prospective study have identified several critical areas at risk of failure. These areas include non‐optimized treatment delivery, inadequate patient monitoring, and lack of safety training, leading to radiation contamination from the dose excreted by the patients after treatment administration. A segmented FTA was created based on the FMEA results, focusing on radiation contamination with a high RPN value.ConclusionBy identifying the root causes of failures and proposing targeted improvements to the existing QM measures, this analysis enhances safety in treatment delivery of ‐based RPTs. Given the limited number of prospective risk analysis studies in RPTs, our research addresses the necessity for more such studies and recommends methods to apply this study to other RPTs.

show abstract

Logistical, technical, and radiation safety aspects of establishing a radiopharmaceutical therapy program: A case in Lutetium‐177 prostate‐specific membrane antigen (PSMA) therapy

Cited by 4 publications

References 26 publications

A single-institution experience with 177Lu RPT workflow improvements and qualifying the SPECT/CT imaging for dosimetry

A single-institution experience with 177Lu RPT workflow improvements and qualifying the SPECT/CT imaging for dosimetry

Logistical, technical, and radiation safety aspects of establishing a radiopharmaceutical therapy program: A case in Lutetium‐177 prostate‐specific membrane antigen (PSMA) therapy

Enhancing safety: Multi‐institutional FMEA and FTA on 177Lu$^{177}{\rm Lu}$‐based radio‐pharmaceutical therapy

Contact Info

Product

Resources

About