Prasad Kavya, Serencsits Brian E, Chu Bae P, Dauer Lawrence T, Donzelli Maria, Basu Ellen, Kramer Kim, Pandit-Taskar Neeta
Memorial Sloan Kettering Cancer Center.
Res Sq. 2024 Feb 28:rs.3.rs-3969388. doi: 10.21203/rs.3.rs-3969388/v1.
Radiolabeled antibody I-omburtamab was administered intraventricularly in patients with leptomeningeal disease under an institutionally approved study (#NCT03275402). Radiation safety precautions were tailored for individual patients, enabling outpatient treatment based on in-depth, evidence-based recommendations for such precautions. The imperative advancement of streamlined therapeutic administration procedures, eliminating the necessity for inpatient isolation and resource-intensive measures, holds pivotal significance. This development bears broader implications for analogous therapies within the pediatric patient demographic.
Intraventricular radioimmunotherapy (RIT) with 925-1850 MBq (25-50 mCi) of I-omburtamab was administered via the Ommaya reservoir, in designated rooms within the pediatric ambulatory care center. Dosimeters were provided to staff involved in patient care to evaluate exposure during injection and post-administration. Post-administration exposure rate readings from the patient on contact, at 0.3 m, and at 1 m were taken within the first 30 minutes, and the room was surveyed after patient discharge. Duration of radiation exposure was calculated using standard U.S. Nuclear Regulatory Commission (US NRC) regulatory guidance recommendations combined with mean exposure rates and whole-body clearance estimates. Exposure rate measurements and clearance data provided patient-specific precautions for four cohorts by age: < 3 y/o, 3-10 y/o, 10-18 y/o, and 18+.
Post-administration exposure rates for patients ranged from 0.16-0.46 μSv/hr/MBq at 1 ft and 0.03-0.08 μSv/hr/MBq at 1 m. Radiation exposure duration ranged from 1-10 days after release for the four evaluated cohorts. Based on the highest measured exposure rates and slowest whole-body clearance, the longest precautions were approximately 78% lower than the regulatory guidance recommendations. Radiation exposure to staff associated with I-omburtamab per administration was substantially below the annual regulatory threshold for individual exposure monitoring.
I-omburtamab can be administered on an outpatient basis, using appropriate patient-based radiation safety precautions that employ patient-specific exposure rate and biological clearance parameters. This trial is registered with the National Library of Medicine's ClinicalTrials.gov. The registration number is NCT03275402, and it was registered on 7 September 2017. The web link is included here. https://clinicaltrials.gov/study/NCT03275402.
在一项机构批准的研究（#NCT03275402）中，向患有柔脑膜疾病的患者脑室内注射了放射性标记抗体I-omburtamab。针对个体患者制定了辐射安全预防措施，根据此类预防措施的深入、循证建议实现门诊治疗。简化治疗给药程序的迫切进展，消除了住院隔离和资源密集型措施的必要性，具有关键意义。这一进展对儿科患者群体中的类似疗法具有更广泛的影响。
在儿科门诊护理中心的指定房间内，通过Ommaya储液器向患者脑室内注射925 - 1850 MBq（25 - 50 mCi）的I-omburtamab进行放射免疫治疗（RIT）。为参与患者护理的工作人员提供剂量计，以评估注射期间和给药后的暴露情况。在给药后的前30分钟内，对接触患者时、距离患者0.3米处和1米处的患者进行给药后暴露率读数，并在患者出院后对房间进行检测。使用美国核管理委员会（US NRC）的标准监管指南建议，结合平均暴露率和全身清除率估计值，计算辐射暴露持续时间。暴露率测量和清除数据为四个年龄组提供了针对患者的预防措施：<3岁、3 - 10岁、10 - 18岁和18岁以上。
患者给药后的暴露率在距离1英尺处为0.16 - 0.46 μSv/hr/MBq，在距离1米处为0.03 - 0.08 μSv/hr/MBq。四个评估队列在出院后的辐射暴露持续时间为1 - 10天。基于最高测量暴露率和最慢全身清除率，最长的预防措施比监管指南建议低约78%。每次给予I-omburtamab时，工作人员所受的辐射暴露大大低于个体暴露监测的年度监管阈值。
使用基于患者的适当辐射安全预防措施，采用患者特异性暴露率和生物清除参数，I-omburtamab可以在门诊给药。本试验已在美国国立医学图书馆的ClinicalTrials.gov上注册。注册号为NCT03275402，于2017年9月7日注册。网络链接如下。https://clinicaltrials.gov/study/NCT03275402 。
