PURPOSE: To assist radiation oncology centers in implementing Lutetium-177-dotatate ( 177 Lu) radiopharmaceutical therapy for midgut neuroendocrine tumors. Here we describe our workflow and how it was revised based on our initial experience on an expanded access protocol (EAP). METHODS: A treatment team/area was identified. An IV-pump-based infusion technique was implemented. Exposure-based techniques were implemented to determine completion of administration, administered activity, and patient releasability. Acute toxicities were assessed at each fraction. A workflow failure modes and effects analysis (FMEA) was performed. RESULTS: A total of 22 patients were treated: 11 patients during EAP (36 administrations) and 11 patients after EAP (44 administrations). Mean 177 Lu infusion time was 37 min (range 26e65 min). Mean administered activity was 97% (range 90e99%). Mean patient exposures at 1 m were 1.9 mR/h (range 1.0e4.1 mR/h) post-177 Lu and 0.9 mR/h (range 0.4e1.8 mR/h) at discharge, rendering patients releasable with instructions. Treatment area was decontaminated and released same day. All patients in the EAP experienced nausea, and nearly half experienced emesis despite premedication with antiemetics. Peripheral IV-line complications occurred in six treatments (16.7%), halting administration in 2 cases (5.6%). We transitioned to peripherally inserted central catheter (PICC)-lines and revised amino acid formulary after the EAP. The second cohort of 11 patients after EAP were analyzed for PICC-line complications and acute toxicity. Nausea and emesis rates decreased (nausea G1þ 61%e27%; emesis G1þ 23%e7%), and no PICC complications were observed. FMEA revealed that a failure in amino acid preparation was the highest risk. CONCLUSION: 177 Lu-dotatate can be administered safely in an outpatient radiation oncology department.

Background: There is growing interest among pediatric institutions for implementing iodine-131 (I-131) meta-iodobenzylguanidine (MIBG) therapy for treating children with high-risk neuroblastoma. Due to regulations on the medical use of radioactive material (RAM), and the complexity and safety risks associated with the procedure, a multidisciplinary team involving radiation therapy/safety experts is required. Here, we describe methods for implementing pediatric I-131 MIBG therapy and evaluate our program's robustness via failure modes and effects analysis (FMEA). Methods:We formed a multidisciplinary team, involving pediatric oncology, radiation oncology, and radiation safety staff. To evaluate the robustness of the therapy workflow and quantitatively assess potential safety risks, an FMEA was performed. Failure modes were scored (1-10) for their risk of occurrence (O), severity (S), and being undetected (D). Risk priority number (RPN) was calculated from a product of these scores and used to identify high-risk failure modes. Results: A total of 176 failure modes were identified and scored. The majority (94%) of failure modes scored low (RPN <100). The highest risk failure modes were related to training and to drug-infusion procedures, with the highest S scores being (a) caregivers did not understand radiation safety training (O = 5.5, S = 7, D = 5.5, RPN = 212); (b) infusion training of staff was inadequate (O = 5, S = 8, D = 5, RPN = 200); and (c) air in intravenous lines/not monitoring for air in lines (O = 4.5, S = 8, D = 5, RPN = 180). Conclusion: Through use of FMEA methodology, we successfully identified multiple potential points of failure that have allowed us to proactively mitigate risks when implementing a pediatric MIBG program.

Background Biological specimens from patients who have received radiopharmaceuticals are often collected for diagnostic testing and sent to clinical laboratories. Residual radiation has long been assumed to be minimal. However, literature is sparse and may not represent the specimen volumes or spectrum of radionuclides currently seen at National Cancer Institute (NCI)–designated cancer centers. This study examined the radiopharmaceuticals associated with patient specimens received in the hospital core laboratory and assessed the potential risk of external radiation exposure to laboratory personnel. Methods The types and amounts of radiopharmaceuticals administered in a large metropolitan hospital system were retrospectively examined over a 20-month study period. The associated biological specimens sent to the largest core laboratory in the system for testing were evaluated. In addition, manual survey meter assessment of random clinical specimens and weekly wipe tests were performed for 44 weeks, and wearable and environmental dosimeters were placed for 6 months. Results Over 11 000 specimens, collected within 5 physical half-lives of radiopharmaceutical administration, were processed by our laboratory. Manual survey meter assessment of random clinical specimens routinely identified radioactive specimens. If held in a closed palm for &gt;2 min, many samples could potentially deliver a 0.02 mSv effective dose of radiation. Conclusions The laboratory regularly receives radioactive patient specimens without radioactive labels. Although the vast majority of these are blood specimens associated with low-dose diagnostic radiopharmaceuticals, some samples may be capable of delivering a significant amount of radiation. Recommendations for laboratories associated with NCI cancer centers are given.

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.

therapy (VMAT) and helical tomotherapy (HT)) for total body irradiation as conditioning regimen in patients undergoing hematopoietic stem cell transplant with an updated lung dose limit based on recently published clinical data on lung toxicities. We report comparison and initial clinical experience in dosimetric plan quality, patient setup correction techniques, and dose delivery efficiency. Materials/Methods: We reviewed treatment planning and delivery record for the initial seven patients that were prospectively enrolled in this study. TBI was given to each patient in 8 fractions at 165 cGy per fraction. Patient height ranged from 154.9 to 193.5 cm. The planning target volume (PTV) is the whole body excluding the lung volume. The total lung and 15 additional normal organs were included in plan optimization and dosimetric evaluation. In planning, mean lung dose (MLD) limit was 8 Gy and maximum dose (Dmax) to normal organs was required to be < 130% of the prescribed dose with a recommended goal of < 115%. Four patients received TBI with HT and the other three on a conventional Linac. Patients treated with HT had an upper body HT plan with a rotating gantry using a 5-cm jaw and a lower extremity HT plan using static AP/PA HT fields. Patients treated on a conventional Linac had an upper body VMAT plan using 9 to 10 VMAT fields and a lower body plan with either VMAT fields or static AP/PA fields. The virtual bolus technique was used in VMAT plans to reduce dose variation due to setup uncertainty. The VMAT fields used a 6 MV photon beam with a 90˚collimator angle and had an overlap of at least 2 cm between adjacent fields along the longitudinal direction. All the plans were normalized so that 85% of the PTV received at least 13.2 Gy in total dose. Results: In the upper body HT plans the average PTV dose was 13.6 Gy (range: 13.5 − 13.7 Gy), the MLD averaged at 7.71 Gy (range: 7.21 − 7.95 Gy), and Dmax was < 115% of prescribed dose for at least 14 normal organs. In the upper-body VMAT plans the average PTV dose was 13.95 Gy (range: 13.86 − 14.02 Gy), the MLD averaged at 7.12 Gy (range: 6.85 − 7.63 Gy), and Dmax was < 115% of prescribed dose with 1 to 9 normal organs. The Dmax limit of 130% of prescribed dose was achieved in all the plans. In HT treatments, an MVCT scan was used for daily patient setup corrections in both the upper and lower body treatments and the overall treatment time per fraction was 1.23 § 0.21 hours (range: 0.90 − 1.88 hours). In VMAT treatments, both cone beam CT scans and orthogonal kilovoltage images were used for daily patient setup on a conventional Linac and the overall treatment time per fraction was 1.39 § 0.20 hours. Conclusion: Both the HT and VMAT plans achieved adequate lung sparing under our new institutional lung dose limit in TBI. VMAT TBI is clinically feasible and could provide access to more patients for TBI treatments. The two IMRT techniques also allow selective sparing of additional organs in TBI treatments.