The SCARLET trial: a prospective phase II study of somatostatin receptor imaging for potential radiotheranostic application in patients with relapsing and refractory multiple myeloma.

IF 7.6 1区医学 Q1 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING

European Journal of Nuclear Medicine and Molecular Imaging Pub Date : 2025-08-28 DOI:10.1007/s00259-025-07500-y

Wendy Delbart, Ioannis Karfis, Marie Vercruyssen, Roland De Wind, Nathalie Meuleman, Zéna Wimana, Patrick Flamen, Erwin Woff

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引用次数: 0

Abstract

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 [¹⁸F]F-FDG avidity were prospectively included. Patients underwent a [⁶⁸Ga]Ga-DOTATATE PET/CT within 4 weeks after [¹⁸F]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 [¹⁸F]F-FDG-avid FLs without corresponding [⁶⁸Ga]Ga-DOTATATE uptake, identification of ≥ 3 [⁶⁸Ga]Ga-DOTATATE FLs, and no diffuse bone marrow uptake on [⁶⁸Ga]Ga-DOTATATE PET/CT.

Results: All patients had measurable disease on [¹⁸F]F-FDG PET/CT. [⁶⁸Ga]Ga-DOTATATE uptake was observed in all patients, with FLs identified in 15 of the 17 patients. The combined [¹⁸F]F-FDG and [⁶⁸Ga]Ga-DOTATATE PET/CT analyses classified patients into 4 categories: (1) Identical FLs identified by both radiotracers; (2) All [¹⁸F]F-FDG FLs showed corresponding [⁶⁸Ga]Ga-DOTATATE uptake, with additional [⁶⁸Ga]Ga-DOTATATE FLs; (3) Only some of the [¹⁸F]F-FDG FLs showed [⁶⁸Ga]Ga-DOTATATE uptake; (4) Diffuse bone marrow uptake of [⁶⁸Ga]Ga-DOTATATE, preventing FLs identification. Patients in categories 1 and 2 were deemed PRRT-eligible if they had ≥ 3 FLs on [⁶⁸Ga]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 [¹⁸F]F-FDG PET/CT, [⁶⁸Ga]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.

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SCARLET试验：一项生长抑素受体成像的前瞻性II期研究，用于复发和难治性多发性骨髓瘤患者的放射治疗应用。

目的：本II期研究探讨生长抑素受体（SSTR）在复发和难治性多发性骨髓瘤（rrMM）患者中的表达，以寻求潜在的放射治疗应用。方法：前瞻性纳入17例表现为[18F]F-FDG贪婪的三级暴露rrMM患者。患者在[18F]F-FDG PET/CT后4周内进行了[68Ga]Ga-DOTATATE PET/CT检查，作为标准检查的一部分。局灶性病变（FLs）在两次扫描中都被确定，并被定义为局灶性摄取高于股骨骨髓背景摄取。根据以下标准确定肽受体放射性核素治疗（PRRT）的资格：没有[18F]F-FDG-avid fl而没有相应的[68Ga]Ga-DOTATATE摄取，鉴定出≥3个[68Ga]Ga-DOTATATE fl，并且在[68Ga]Ga-DOTATATE PET/CT上没有弥漫性骨髓摄取。结果：所有患者在[18F]F-FDG PET/CT上均有可测量的病变。[68Ga]所有患者均观察到Ga-DOTATATE摄取，17例患者中有15例发现fl。联合[18F]F-FDG和[68Ga]Ga-DOTATATE PET/CT分析将患者分为4类：(1)两种放射性示踪剂鉴定出相同的fl；(2)所有[18F]F-FDG FLs均有相应的[68Ga]Ga-DOTATATE摄取，并有额外的[68Ga]Ga-DOTATATE FLs；(3)只有部分[18F]F-FDG荧光素摄取[68Ga]Ga-DOTATATE；(4)弥漫性骨髓摄取[68Ga]Ga-DOTATATE，阻止fl识别。如果1类和2类患者在[68Ga]Ga-DOTATATE PET/CT上有≥3个FLs，则认为符合prrt条件。因此，17例患者中有10例（60%）符合PRRT的资格标准。结论：在经过大量预处理的rrMM患者中，在[18F]F-FDG PET/CT上显示有明显的疾病，[68Ga]Ga-DOTATATE PET/CT识别出60%的患者为PRRT的合格候选人，这表明在选定的患者中有可能出现PRRT的新适应症。试验注册：NCT04379817, 2020年5月4日注册，https://clinicaltrials.gov/study/NCT04379817?cond=multiple%20myeloma&term=scarlet&rank=1。

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来源期刊

European Journal of Nuclear Medicine and Molecular Imaging 医学-核医学

CiteScore

15.60

自引率

9.90%

发文量

392

审稿时长

3 months

期刊介绍： The European Journal of Nuclear Medicine and Molecular Imaging serves as a platform for the exchange of clinical and scientific information within nuclear medicine and related professions. It welcomes international submissions from professionals involved in the functional, metabolic, and molecular investigation of diseases. The journal's coverage spans physics, dosimetry, radiation biology, radiochemistry, and pharmacy, providing high-quality peer review by experts in the field. Known for highly cited and downloaded articles, it ensures global visibility for research work and is part of the EJNMMI journal family.