SCARLET试验：一项关于生长抑素受体成像在复发难治性多发性骨髓瘤患者中潜在放射诊疗应用的前瞻性II期研究。
The SCARLET trial: a prospective phase II study of somatostatin receptor imaging for potential radiotheranostic application in patients with relapsing and refractory multiple myeloma.
作者信息
Delbart Wendy, Karfis Ioannis, Vercruyssen Marie, De Wind Roland, Meuleman Nathalie, Wimana Zéna, Flamen Patrick, Woff Erwin
机构信息
Nuclear Medicine Department, Institut Jules Bordet, ENETS Centre of Excellence, Hôpital Universitaire de Bruxelles, Université Libre de Bruxelles, Brussels, Belgium.
Hematology Department, Institut Jules Bordet, ENETS Centre of Excellence, Hôpital Universitaire de Bruxelles, Université Libre de Bruxelles, Brussels, Belgium.
出版信息
Eur J Nucl Med Mol Imaging. 2025 Aug 28. doi: 10.1007/s00259-025-07500-y.
PURPOSE
This phase II study investigates the expression of somatostatin receptors (SSTR) in relapsing and refractory multiple myeloma (rrMM) patients for potential radiotheranostic application.
METHODS
Seventeen triple-class exposed rrMM patients who demonstrate [F]F-FDG avidity were prospectively included. Patients underwent a [Ga]Ga-DOTATATE PET/CT within 4 weeks after [F]F-FDG PET/CT, which was performed as part of the standard workup. Focal lesions (FLs) were identified on both scans and were defined as focal uptake higher than the femoral bone marrow background uptake. Peptide Receptor Radionuclide Therapy (PRRT) eligibility was determined based on the following criteria: absence of [F]F-FDG-avid FLs without corresponding [Ga]Ga-DOTATATE uptake, identification of ≥ 3 [Ga]Ga-DOTATATE FLs, and no diffuse bone marrow uptake on [Ga]Ga-DOTATATE PET/CT.
RESULTS
All patients had measurable disease on [F]F-FDG PET/CT. [Ga]Ga-DOTATATE uptake was observed in all patients, with FLs identified in 15 of the 17 patients. The combined [F]F-FDG and [Ga]Ga-DOTATATE PET/CT analyses classified patients into 4 categories: (1) Identical FLs identified by both radiotracers; (2) All [F]F-FDG FLs showed corresponding [Ga]Ga-DOTATATE uptake, with additional [Ga]Ga-DOTATATE FLs; (3) Only some of the [F]F-FDG FLs showed [Ga]Ga-DOTATATE uptake; (4) Diffuse bone marrow uptake of [Ga]Ga-DOTATATE, preventing FLs identification. Patients in categories 1 and 2 were deemed PRRT-eligible if they had ≥ 3 FLs on [Ga]Ga-DOTATATE PET/CT. Consequently, 10 out of 17 patients (60%) met the PRRT eligibility criteria.
CONCLUSION
In heavily pretreated rrMM patients showing avid disease on [F]F-FDG PET/CT, [Ga]Ga-DOTATATE PET/CT identified 60% of patients as eligible candidates for PRRT, suggesting a potential new indication for PRRT in selected patients.
TRIAL REGISTRATION
NCT04379817, Registered on 4 May 2020, https://clinicaltrials.gov/study/NCT04379817?cond=multiple%20myeloma&term=scarlet&rank=1.
目的
本II期研究调查复发难治性多发性骨髓瘤（rrMM）患者中生长抑素受体（SSTR）的表达，以探索其在放射诊疗方面的潜在应用。
方法
前瞻性纳入17例经三种治疗方案治疗后复发且[F]F-FDG摄取阳性的rrMM患者。患者在[F]F-FDG PET/CT检查后4周内接受[Ga]Ga-DOTATATE PET/CT检查，后者作为标准检查的一部分。在两次扫描中均识别出局灶性病变（FLs），其定义为局灶性摄取高于股骨骨髓本底摄取。基于以下标准确定肽受体放射性核素治疗（PRRT）的适用性：不存在无相应[Ga]Ga-DOTATATE摄取的[F]F-FDG摄取阳性FLs、识别出≥3个[Ga]Ga-DOTATATE FLs且[Ga]Ga-DOTATATE PET/CT上无弥漫性骨髓摄取。
结果
所有患者在[F]F-FDG PET/CT上均有可测量的疾病。所有患者均观察到[Ga]Ga-DOTATATE摄取，17例患者中有15例识别出FLs。联合[F]F-FDG和[Ga]Ga-DOTATATE PET/CT分析将患者分为4类：（1）两种放射性示踪剂均识别出相同的FLs；（2）所有[F]F-FDG FLs均显示相应的[Ga]Ga-DOTATATE摄取，且有额外的[Ga]Ga-DOTATATE FLs；（3）仅部分[F]F-FDG FLs显示[Ga]Ga-DOTATATE摄取；（4）[Ga]Ga-DOTATATE弥漫性骨髓摄取，无法识别FLs。如果第1类和第2类患者在[Ga]Ga-DOTATATE PET/CT上有≥3个FLs，则被认为符合PRRT条件。因此，17例患者中有10例（60%）符合PRRT适用性标准。
结论
在经大量预处理且在[F]F-FDG PET/CT上显示疾病摄取阳性的rrMM患者中，[Ga]Ga-DOTATATE PET/CT确定60%的患者为PRRT的合适候选者，提示PRRT在部分患者中有潜在的新适应症。
试验注册
NCT04379817，于2020年5月4日注册，https://clinicaltrials.gov/study/NCT04379817?cond=multiple%20myeloma&term=scarlet&rank=1 。
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