[F]AlF-NOTA-奥曲肽PET/MRI与[Ga]Ga-DOTATATE PET/CT在神经内分泌肿瘤患者中的前瞻性比较。
Prospective comparison of [F]AlF-NOTA-octreotide PET/MRI to [Ga]Ga-DOTATATE PET/CT in neuroendocrine tumor patients.
作者信息
Boeckxstaens Lennert, Pauwels Elin, Vandecaveye Vincent, Deckers Wies, Cleeren Frederik, Dekervel Jeroen, Vandamme Timon, Serdons Kim, Koole Michel, Bormans Guy, Laenen Annouschka, Clement Paul M, Geboes Karen, Van Cutsem Eric, Nackaerts Kristiaan, Stroobants Sigrid, Verslype Chris, Van Laere Koen, Deroose Christophe M
机构信息
Nuclear Medicine, University Hospitals Leuven and Nuclear Medicine and Molecular Imaging,, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium", Campus Gasthuisberg, Nucleaire Geneeskunde, Herestraat 49, 3000, Leuven, Belgium.
Radiology, Department of Imaging and Pathology, University Hospitals Leuven and Division of Translational MRI, KU Leuven, Leuven, Belgium.
出版信息
EJNMMI Res. 2023 Jun 1;13(1):53. doi: 10.1186/s13550-023-01003-3.
BACKGROUND
Fluorine-18-labeled SSAs have the potential to become the next-generation tracer in SSTR-imaging in neuroendocrine tumor (NET) patients given their logistical advantages over the current gold standard gallium-68-labeled SSAs. In particular, [F]AlF-OC has already shown excellent clinical performance. We demonstrated in our previous report from our prospective multicenter trial that [F]AlF-OC PET/CT outperforms [Ga]Ga-DOTA-SSA, but histological confirmation was lacking due to ethical and practical reasons. In this second arm, we therefore aimed to provide evidence that the vast majority of [F]AlF-OC PET lesions are in fact true NET lesions by analyzing their MR characteristics on simultaneously acquired MRI. We had a special interest in lesions solely detected by [F]AlF-OC ("incremental lesions").
METHODS
Ten patients with a histologically confirmed neuroendocrine tumor (NET) and a standard-of-care [Ga]Ga-DOTATATE PET/CT, performed within 3 months, were prospectively included. Patients underwent a whole-body PET/MRI (TOF, 3 T, GE Signa), 2 hours after IV injection of 4 MBq/kg [F]AlF-OC. Positive PET lesions were evaluated for a corresponding lesion on MRI. The diagnostic performance of both PET tracers was evaluated by determining the detection ratio (DR) for each scan and the differential detection ratio (DDR) per patient.
RESULTS
In total, 195 unique lesions were detected: 167 with [Ga]Ga-DOTATATE and 193 with [F]AlF-OC. The DR for [F]AlF-OC was 99.1% versus 91.4% for [Ga]Ga-DOTATATE, significant for non-inferiority testing (p = 0.0001). Out of these 193 [F]AlF-OC lesions, 96.2% were confirmed by MRI to be NET lesions. Thirty-three incremental lesions were identified by [F]AlF-OC, of which 91% were confirmed by MRI and considered true positives.
CONCLUSION
The DR of [F]AlF-OC was numerically higher and non-inferior to the DR of [Ga]Ga-DOTATATE. [F]AlF-OC lesions and especially incremental lesions were confirmed as true positives by MRI in more than 90% of lesions. Taken together, these data further validate [F]AlF-OC as a new alternative for SSTR PET in clinical practice. Trial registration ClinicalTrials.gov: NCT04552847. Registered 17 September 2020, https://beta.
CLINICALTRIALS
gov/study/NCT04552847.
背景
鉴于¹⁸F标记的生长抑素类似物（SSAs）相较于当前的金标准⁶⁸Ga标记的SSAs具有后勤保障方面的优势，其有潜力成为神经内分泌肿瘤（NET）患者生长抑素受体（SSTR）成像的下一代示踪剂。特别是，[¹⁸F]AlF-OC已显示出优异的临床性能。我们在之前的前瞻性多中心试验报告中表明，[¹⁸F]AlF-OC PET/CT的表现优于[⁶⁸Ga]Ga-DOTA-SSA，但由于伦理和实际原因，缺乏组织学证实。因此，在本研究的第二部分中，我们旨在通过分析同时采集的MRI上[¹⁸F]AlF-OC PET病变的MR特征，提供证据证明绝大多数[¹⁸F]AlF-OC PET病变实际上是真正的NET病变。我们对仅由[¹⁸F]AlF-OC检测到的病变（“增量病变”）特别感兴趣。
方法
前瞻性纳入10例经组织学确诊的神经内分泌肿瘤（NET）患者，这些患者在3个月内接受了标准治疗的[⁶⁸Ga]Ga-DOTATATE PET/CT检查。患者在静脉注射4 MBq/kg [¹⁸F]AlF-OC后2小时接受全身PET/MRI（TOF，3T，GE Signa）检查。对PET阳性病变进行MRI上相应病变的评估。通过确定每次扫描的检测率（DR）和每位患者的差异检测率（DDR）来评估两种PET示踪剂的诊断性能。
结果
总共检测到195个独特病变：[⁶⁸Ga]Ga-DOTATATE检测到167个，[¹⁸F]AlF-OC检测到193个。[¹⁸F]AlF-OC的DR为99.1%，而[⁶⁸Ga]Ga-DOTATATE为91.4%，非劣效性检验具有显著性（p = 0.0001）。在这193个[¹⁸F]AlF-OC病变中，96.2%经MRI证实为NET病变。[¹⁸F]AlF-OC识别出33个增量病变，其中91%经MRI证实并被视为真阳性。
结论
[¹⁸F]AlF-OC的DR在数值上更高且不劣于[⁶⁸Ga]Ga-DOTATATE的DR。[¹⁸F]AlF-OC病变，尤其是增量病变，在超过90%的病变中经MRI证实为真阳性。综上所述，这些数据进一步验证了[¹⁸F]AlF-OC作为临床实践中SSTR PET的一种新替代方法。试验注册ClinicalTrials.gov：NCT04552847。于2020年9月17日注册，https://beta.clinicaltrials.gov/study/NCT04552847。
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