[^99mTc]Tc-NTP 15 - 5, a new proteoglycan tracer for functional imaging of joint cartilage: phase I (CARSPECT).

IF 3.1 3区医学 Q1 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING

EJNMMI Research Pub Date : 2025-09-26 DOI:10.1186/s13550-025-01318-3

Marion Chanchou, Emilie Thivat, Sylvain Mathieu, Sophie Levesque, Nicolas Sas, Philippe Auzeloux, Tommy Billoux, Ioana Molnar, Elodie Jouberton, Jacques Rouanet, Giovanna Fois, Lydia Maigne, Frédérique Penault-Llorca, Elisabeth Miot-Noirault, Xavier Durando, Florent Cachin

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引用次数: 0

Abstract

Background: [^99mTc]Tc-NTP 15 - 5 showed affinity for joint cartilage proteoglycans on preclinical studies but has not been tested in humans. This phase I trial (CARPECT: NCT04481230) aims to define the optimal of [^99mTc]Tc-NTP 15 - 5 injected activity to obtain the best visual contrast of cartilage, without toxicity. Quantitative analyses of cartilage, periarticular uptakes, biodistribution, pharmacokinetic and dosimetry of this new tracer were also studied.

Results: Between November 2020 and June 2022, five patients with unilateral knee osteoarthritis or breast cancer treated with hormonal therapy inducing cartilage disease were injected with [^99mTc]Tc-NTP 15 - 5, at increasing activity levels: 5, 10 and 15 MBq/kg. No major toxicity was reported, according to NCICTC 4.0 scale. With an activity of 15 MBq/Kg, the median rate of joint uptakes higher than diaphysis' one on whole body planar scintigraphy was 80.6% (80.60-85.45) at 2 h p.i. and increased with time. S/N ratio with muscular background measured on SPECT-CT was superior to 3 from 2h30 p.i for cartilage. Uptake evolution depending on time from 1h00 to 6h30 p.i. permitted to discriminate cartilage and pooled proteoglycan structures from background and cartilage from ligaments + tendons for all examination times (p < 0.001), and cartilage from bursa at 1 h p.i. (p < 0.05). Pharmacokinetic, biodistribution and dosimetry were in line with preclinical studies.

Conclusions: This study confirms the usability and accuracy of [^99mTc]Tc-NTP 15 - 5 for cartilage human functional imaging 2 h after injection, at 15 MBq/kg.

Trial registration: Clinicaltrials.gov: NCT04481230. https://clinicaltrials.gov/ct2/show/NCT04481230 . Registration date: November, 12th, 2020.

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[99mTc]Tc-NTP 15 - 5，一种用于关节软骨功能成像的新型蛋白聚糖示踪剂：I期（CARSPECT）。

背景：[99mTc]Tc-NTP 15 - 5在临床前研究中显示出对关节软骨蛋白聚糖的亲和力，但尚未在人体中进行测试。该I期试验（CARPECT: NCT04481230）旨在确定[99mTc]Tc-NTP 15 - 5注射活性的最佳水平，以获得最佳的软骨视觉对比，且无毒性。对该新型示踪剂的软骨、关节周摄取、生物分布、药代动力学和剂量学进行了定量分析。结果：在2020年11月至2022年6月期间，5例单侧膝关节骨关节炎或乳腺癌患者接受激素治疗诱导软骨疾病注射[99mTc]Tc-NTP 15 - 5，活动水平分别为5、10和15 MBq/kg。根据NCICTC 4.0级，无重大毒性报告。以15 MBq/Kg为活性，在2 h的全身平面显像上，关节摄取率高于骨干的中位数为80.6%(80.60 ~ 85.45)，且随时间增加而增加。在SPECT-CT上测量肌肉背景的信噪比优于软骨2h30 p.i.的3。从1h00到6h30 p.i.的摄取进化取决于时间，允许在所有检查时间内从背景中区分软骨和混合蛋白多糖结构，从韧带+肌腱中区分软骨(p)结论：本研究证实了注射后2小时，以15 MBq/kg的速度，[99mTc]Tc-NTP 15 - 5对软骨人体功能成像的可用性和准确性。试验注册：Clinicaltrials.gov: NCT04481230。https://clinicaltrials.gov/ct2/show/NCT04481230。报名日期：2020年11月12日。

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来源期刊

EJNMMI Research RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING&nb-

CiteScore

5.90

自引率

3.10%

发文量

审稿时长

13 weeks

期刊介绍： EJNMMI Research publishes new basic, translational and clinical research in the field of nuclear medicine and molecular imaging. Regular features include original research articles, rapid communication of preliminary data on innovative research, interesting case reports, editorials, and letters to the editor. Educational articles on basic sciences, fundamental aspects and controversy related to pre-clinical and clinical research or ethical aspects of research are also welcome. Timely reviews provide updates on current applications, issues in imaging research and translational aspects of nuclear medicine and molecular imaging technologies. The main emphasis is placed on the development of targeted imaging with radiopharmaceuticals within the broader context of molecular probes to enhance understanding and characterisation of the complex biological processes underlying disease and to develop, test and guide new treatment modalities, including radionuclide therapy.