Pfeifer Andreas, Knigge Ulrich, Binderup Tina, Mortensen Jann, Oturai Peter, Loft Annika, Berthelsen Anne Kiil, Langer Seppo W, Rasmussen Palle, Elema Dennis, von Benzon Eric, Højgaard Liselotte, Kjaer Andreas
Department of Clinical Physiology, Nuclear Medicine & PET and Cluster for Molecular Imaging, Rigshospitalet and University of Copenhagen, Copenhagen, Denmark Department of Nuclear Medicine, Helios-Klinikum Berlin-Buch, Berlin, Germany ENETS Center of Excellence for Neuroendocrine Tumors, Copenhagen, Denmark.
Department of Clinical Physiology, Nuclear Medicine & PET and Cluster for Molecular Imaging, Rigshospitalet and University of Copenhagen, Copenhagen, Denmark ENETS Center of Excellence for Neuroendocrine Tumors, Copenhagen, Denmark Departments of Surgical Gastroenterology C and Medical Endocrinology, Rigshospitalet, Copenhagen, Denmark.
J Nucl Med. 2015 Jun;56(6):847-54. doi: 10.2967/jnumed.115.156539. Epub 2015 May 7.
Neuroendocrine tumors (NETs) can be visualized using radiolabeled somatostatin analogs. We have previously shown the clinical potential of (64)Cu-DOTATATE in a small first-in-human feasibility study. The aim of the present study was, in a larger prospective design, to compare on a head-to-head basis the performance of (64)Cu-DOTATATE and (111)In-diethylenetriaminepentaacetic acid (DTPA)-octreotide ((111)In-DTPA-OC) as a basis for implementing (64)Cu-DOTATATE as a routine.
We prospectively enrolled 112 patients with pathologically confirmed NETs of gastroenteropancreatic or pulmonary origin. All patients underwent both PET/CT with (64)Cu-DOTATATE and SPECT/CT with (111)In-DTPA-OC within 60 d. PET scans were acquired 1 h after injection of 202 MBq (range, 183-232 MBq) of (64)Cu-DOTATATE after a diagnostic contrast-enhanced CT scan. Patients were followed for 42-60 mo for evaluation of discrepant imaging findings. The McNemar test was used to compare the diagnostic performance.
Eighty-seven patients were congruently PET- and SPECT-positive. No SPECT-positive cases were PET-negative, whereas 10 false-negative SPECT cases were identified using PET. The diagnostic sensitivity and accuracy of (64)Cu-DOTATATE (97% for both) were significantly better than those of (111)In-DTPA-OC (87% and 88%, respectively, P = 0.017). In 84 patients (75%), (64)Cu-DOTATATE identified more lesions than (111)In-DTPA-OC and always at least as many. In total, twice as many lesions were detected with (64)Cu-DOTATATE than with (111)In-DTPA-OC. Moreover, in 40 of 112 cases (36%) lesions were detected by (64)Cu-DOTATATE in organs not identified as disease-involved by (111)In-DTPA-OC.
With these results, we demonstrate that (64)Cu-DOTATATE is far superior to (111)In-DTPA-OC in diagnostic performance in NET patients. Therefore, we do not hesitate to recommend implementation of (64)Cu-DOTATATE as a replacement for (111)In-DTPA-OC.
神经内分泌肿瘤（NETs）可使用放射性标记的生长抑素类似物进行显影。我们之前在一项小型的首次人体可行性研究中展示了（64）Cu-DOTATATE的临床潜力。本研究的目的是，在一个更大的前瞻性设计中，直接比较（64）Cu-DOTATATE和（111）铟-二乙烯三胺五乙酸（DTPA）-奥曲肽（（111）In-DTPA-OC）的性能，以此作为将（64）Cu-DOTATATE作为常规方法实施的依据。
我们前瞻性纳入了112例经病理证实的胃肠胰或肺源性NETs患者。所有患者在60天内分别接受了（64）Cu-DOTATATE的PET/CT检查和（111）In-DTPA-OC的SPECT/CT检查。在进行诊断性增强CT扫描后，注射202MBq（范围为183 - 232MBq）的（64）Cu-DOTATATE后1小时进行PET扫描。对患者进行42 - 60个月的随访，以评估不一致的影像学检查结果。采用McNemar检验比较诊断性能。
87例患者PET和SPECT均为阳性。没有SPECT阳性而PET阴性的病例，而使用PET检测到10例假阴性SPECT病例。（64）Cu-DOTATATE的诊断敏感性和准确性（均为97%）显著优于（111）In-DTPA-OC（分别为87%和88%，P = 0.017）。在84例患者（75%）中，（64）Cu-DOTATATE发现的病灶比（111）In-DTPA-OC更多，且至少与后者一样多。总的来说，（64）Cu-DOTATATE检测到的病灶数量是（111）In-DTPA-OC的两倍。此外，在112例病例中的40例（36%）中，（64）Cu-DOTATATE在（111）In-DTPA-OC未确定为病变累及的器官中检测到了病灶。
基于这些结果，我们证明在NET患者的诊断性能方面，（64）Cu-DOTATATE远优于（111）In-DTPA-OC。因此，我们毫不犹豫地建议采用（64）Cu-DOTATATE替代（111）In-DTPA-OC。
