Comparison of PET/CT versus CT only in the assessment of new heterotopic ossification bone lesions in patients with fibrodysplasia ossificans progressiva

IF 3.5 2区医学 Q2 ENDOCRINOLOGY & METABOLISM

Bone Pub Date : 2024-10-10 DOI:10.1016/j.bone.2024.117280

Dinko González Trotter, Jennifer McGinniss, Kusha Mohammadi, Bret J. Musser, Gary A. Herman, Scott Mellis, Aris N. Economides

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Abstract

Fibrodysplasia ossificans progressiva (FOP) is an ultra-rare disorder characterized by the deposition of bone in soft tissues, known as heterotopic ossification (HO). This post hoc analysis compared the performance of two imaging modalities for the detection and volumetric measurement of new HO lesions. LUMINA-1, a phase 2, randomized, double-blind study (NCT03188666), evaluated the safety and efficacy of garetosmab, an anti-activin A antibody, versus placebo in adult patients with FOP. From baseline through to week 28, ¹⁸F-labeled sodium fluoride positron emission tomography (PET)/X-ray computed tomography (CT) and CT-only scans prospectively acquired during the initial placebo-controlled period of the study were independently reviewed by two sets of fixed blinded readers plus an adjudicator for the presence and volume of new HO lesions. The number of patients with new lesions was 14/44 (31.8 %) and 12/44 (27.3 %) as detected by PET/CT and CT only, respectively. The aggregate number/volume of new lesions were very similar both for the placebo and the garetosmab group between PET/CT (27/245.0 cm³ and 3/21.3 cm³, respectively) and CT only (37/261.8 cm³ and 1/0.1 cm³, respectively). The mean (standard deviation) number of new lesions per patient by PET/CT through week 28 was 0.68 (1.57) versus 0.86 (1.95) as detected by CT only. Through week 28, the mean (standard deviation) volume of new lesions per patient detected by PET/CT was 6.05 (14.88) cm³ versus 5.94 (21.13) cm³ by CT only. Moderate agreement between PET/CT and CT-only detection was observed when identifying patients with new lesions, with a kappa coefficient of 0.46 (standard error, 0.146; 95 % confidence interval, 0.17–0.74). CT-only imaging showed similar performance to PET/CT in the detection and characterization of new HO lesions. CT-only imaging therefore is a viable option for the assessment of therapies on new HO in patients with FOP.

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正电子发射计算机断层显像（PET）/计算机断层扫描（CT）与单纯计算机断层扫描（CT）在评估渐进性纤维性骨化症患者新的异位骨化骨病变方面的比较。

纤维增生性骨化症（FOP）是一种超罕见的疾病，其特征是软组织中的骨沉积，即异位骨化（HO）。这项事后分析比较了两种成像模式在检测和测量异位骨化新病灶体积方面的性能。LUMINA-1是一项2期随机双盲研究（NCT03188666），评估了抗活化素A抗体加瑞妥单抗与安慰剂在FOP成年患者中的安全性和有效性。从基线到第28周，在研究的最初安慰剂对照期间前瞻性获得的18F标记的氟化钠正电子发射断层扫描（PET）/X射线计算机断层扫描（CT）和纯CT扫描由两组固定的盲人阅读者和一名评审员独立审查是否存在新的HO病变及其体积。仅 PET/CT 和 CT 检测出新病灶的患者人数分别为 14/44（31.8%）和 12/44（27.3%）。安慰剂组和加瑞妥斯单抗组新病灶的总数/体积在 PET/CT （分别为 27/245.0 立方厘米和 3/21.3 立方厘米）和仅 CT （分别为 37/261.8 立方厘米和 1/0.1 立方厘米）之间非常相似。到第28周时，PET/CT检测到的每位患者新病灶的平均数量（标准偏差）为0.68（1.57）个，而仅通过CT检测到的新病灶数量为0.86（1.95）个。到第 28 周时，PET/CT 检测到的每位患者新病灶的平均体积（标准差）为 6.05 (14.88) cm3，而 CT 仅检测到的为 5.94 (21.13) cm3。在识别新病灶患者时，PET/CT 和纯 CT 检测结果的一致性适中，卡帕系数为 0.46（标准误差为 0.146；95 % 置信区间为 0.17-0.74）。在检测和鉴定新的 HO 病灶方面，纯 CT 成像显示出与 PET/CT 相似的性能。因此，纯 CT 成像是评估 FOP 患者新 HO 治疗方法的可行选择。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Bone 医学-内分泌学与代谢

CiteScore

8.90

自引率

4.90%

发文量

264

审稿时长

30 days

期刊介绍： BONE is an interdisciplinary forum for the rapid publication of original articles and reviews on basic, translational, and clinical aspects of bone and mineral metabolism. The Journal also encourages submissions related to interactions of bone with other organ systems, including cartilage, endocrine, muscle, fat, neural, vascular, gastrointestinal, hematopoietic, and immune systems. Particular attention is placed on the application of experimental studies to clinical practice.