Selivanova Svetlana V, Lavallée Éric, Senta Helena, Caouette Lyne, McEwan Alexander J B, Guérin Brigitte, Lecomte Roger, Turcotte Éric
Sherbrooke Molecular Imaging Center, CRCHUS, Sherbrooke, Quebec, Canada
Department of Nuclear Medicine and Radiobiology, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Sherbrooke, Quebec, Canada; and.
J Nucl Med. 2017 May;58(5):791-798. doi: 10.2967/jnumed.116.178509. Epub 2016 Oct 13.
A single-site prospective open-label clinical study with cyclotron-produced sodium Tc-pertechnetate (Tc-NaTcO) was performed in patients with indications for a thyroid scan to demonstrate the clinical safety and diagnostic efficacy of the drug and to confirm its equivalence with conventional Tc-NaTcO eluted from a generator. Tc-NaTcO was produced from enriched Mo (99.815%) with a cyclotron (24 MeV; 2 h of irradiation) or supplied by a commercial manufacturer (bulk vial eluted from a generator). Eleven patients received 325 ± 29 (mean ± SD) MBq of the cyclotron-produced Tc-NaTcO, whereas the age- and sex-matched controls received a comparable amount of the generator-derived tracer. Whole-body and thyroid planar images were obtained for each participant. In addition to the standard-energy window (140.5 keV ± 7.5%), data were acquired in lower-energy (117 keV ± 10%) and higher-energy (170 keV ± 10%) windows. Vital signs and hematologic and biochemical parameters were monitored before and after tracer administration. Cyclotron-produced Tc-NaTcO showed organ and whole-body distributions identical to those of conventional Tc-NaTcO and was well tolerated. All images led to a clear final diagnosis. The fact that the number of counts in the higher-energy window was significantly higher for cyclotron-produced Tc-NaTcO did not influence image quality in the standard-energy window. Image definition in the standard-energy window with cyclotron-produced Tc was equivalent to that with generator-eluted Tc and had no particular features allowing discrimination between the Tc production methods. The systemic distribution, clinical safety, and imaging efficacy of cyclotron-produced Tc-NaTcO in humans provide supporting evidence for the use of this tracer as an equivalent for generator-eluted Tc-NaTcO in routine clinical practice.
对有甲状腺扫描指征的患者进行了一项单中心前瞻性开放标签临床研究，使用回旋加速器生产的高锝酸钠（Tc-NaTcO），以证明该药物的临床安全性和诊断有效性，并确认其与从发生器洗脱的传统Tc-NaTcO的等效性。Tc-NaTcO由富集的钼（99.815%）通过回旋加速器（24 MeV；照射2小时）生产，或由商业制造商提供（从发生器洗脱的大容量瓶）。11名患者接受了325±29（平均值±标准差）MBq的回旋加速器生产的Tc-NaTcO，而年龄和性别匹配的对照组接受了相当量的发生器衍生示踪剂。为每位参与者获取了全身和甲状腺平面图像。除了标准能量窗（140.5 keV±7.5%）外，还在较低能量（117 keV±10%）和较高能量（170 keV±10%）窗中采集了数据。在给予示踪剂前后监测生命体征以及血液学和生化参数。回旋加速器生产的Tc-NaTcO显示出与传统Tc-NaTcO相同的器官和全身分布，并且耐受性良好。所有图像均得出明确的最终诊断。回旋加速器生产的Tc-NaTcO在较高能量窗中的计数显著更高这一事实并未影响标准能量窗中的图像质量。回旋加速器生产的Tc在标准能量窗中的图像清晰度与发生器洗脱的Tc相当，并且没有允许区分Tc生产方法的特殊特征。回旋加速器生产的Tc-NaTcO在人体中的全身分布、临床安全性和成像效果为在常规临床实践中使用这种示踪剂替代发生器洗脱的Tc-NaTcO提供了支持证据。
