Assessment of 99mTc-NTP 15-5 Uptake on Cartilage, a New Proteoglycan Tracer: Phase I Clinical Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- determination of the recommended dose of 99mTc-NTP 15-5 to obtain the best tracer joints contrast on images without any toxicity
研究概览
简要总结
This study is a phase I clinical trial aimed to determine the recommended dose of 99mTc-NTP 15-5 to obtain the best tracer joints contrast on images without any toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria specific to group 1:
- •Patient with painful unilateral osteoarthritis of the knee as femorotibial pattern defined by a radiographic score of 0/1 from Kellgren / Lawrence and an average WOMAC score> or equal to 4 and by minor disorders at MRI (MOCART 2.0 score> 70).
- •Inclusion criteria specific to group 2:
- •Patient with non-metastatic breast cancer, hormone receptor positive, HER2 negative, with indication for adjuvant therapy with aromatase inhibitor; treatment not yet started.
- •Age <60 years
- •Common inclusion criteria:
- •Patient with at least 31 healthy joints (based on clinical assessment)
- •signed written informed consent.
- •Affiliation to a health insurance scheme.
- •For women of childbearing age : negative serum pregnancy test at inclusion (less than 7 days prior injection of 99mTc-NTP 15-5).
- •Willing and able to comply with study visits, treatment, exams and the protocol.
排除标准
- •Patients <18 years of age.
- •Pregnant or lactating patient.
- •History of known allergy to excipients contained in the solution of 99mTc-NTP 15-5
- •Chronic inflammatory rheumatism (rheumatoid arthritis, spondyloarthropathy, psoriatic arthritis, etc.) diffuse arthritis (at least 3 joints affected), autoimmune connectivitis, fibromyalgia.
- •Known chronic joint pathology: osteoarthritis affecting at least 3 joints, autoimmune disease, inflammatory rheumatism (except unilateral knee arthritis).
- •Persons deprived of their liberty, under guardianship / curatorship, or safeguard of justice.
- •Treatment with NSAIDs or cessation of less than 48 h.
- •Inability to comply with medical requirement / follow-up of the trial for geographic, family, social or psychological reasons. These conditions should be discussed with the patient before registration in the study.
研究组 & 干预措施
99mTc-NTP 15-5 (level 1)
99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg
干预措施: 99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg (Drug)
99mTc-NTP 15-5 (level 2)
99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kg
干预措施: 99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kg (Drug)
99mTc-NTP 15-5 (level 3)
99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg
干预措施: 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg (Drug)
结局指标
主要结局
determination of the recommended dose of 99mTc-NTP 15-5 to obtain the best tracer joints contrast on images without any toxicity
时间窗: Imaging at Day 0 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours post-injection)
defined as the dose from which 100% of patients will present a score 3 (semi-quantitative visual scale on whole body imaging) in at least 80% of healthy joints visualized on scintigraphies performed 2 h or less post-injection and without dose-limiting toxicity (DLT).
dose-limiting toxicity (DLT)
时间窗: 1 week after injection of the 99mTc-NTP 15-5 (Day 0)
defined as any grade 3-4 toxicity according to the NCI-CTCAE (version 4.03)
次要结局
- Pharmacokinetics of 99mTc-NTP 15-5 by assessment of Area Under the Curve (AUC)(at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5)
- Urinary elimination of 99mTc-NTP 15-5(at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5)
- 3D quantification analysis(imaging at Day 0, 30 minutes, 2 hours, 4 hours, 6-8 hours after injection of the 99mTc-NTP 15-5)
- Safety of 99mTc-NTP 15-5 (frequence of adverse events)(1 week after injection of the 99mTc-NTP 15-5 (Day 0))
- Pharmacokinetics of 99mTc-NTP 15-5 by assessment of Maximum Concentration (Cmax)(at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5)
- Pharmacokinetics of 99mTc-NTP 15-5 by assessment of the time take to reach Cmax (Tmax)(at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5)
- Biodistribution of 99mTc-NTP 15-5(imaging at Day 0, 30 minutes, 2 hours, 4 hours, 6-8 hours after injection of the 99mTc-NTP 15-5)
- Dosimetry(imaging at Day 0, 30 minutes, 2 hours, 4 hours, 6-8 hours after injection of the 99mTc-NTP 15-5)