NCT07624994尚未招募2 期
Functional Imaging of Digital Osteoarthritis and Rheumatoid Arthritis Using 99mTc-NTP 15-5 in Nuclear Medicine: Phase II Clinical Study
Centre Jean Perrin2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年8月1日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 2
研究概览
简要总结
This study is a phase Ii clinical trial aimed to evaluate the performance of 99mTc-NTP 15-5 to identify a pathological hand joint in each group ; digital osteoarthrosis and rheumatoid arthritis
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Karnofsky index > 70%
- •Obtaining written, signed and dated informed consent
- •Affiliation to a health insurance plan
- •For women of childbearing age (fertile, after menarche and until postmenopausal unless sterile after surgery) including on GnRH agonist for ovarian suppression: serum pregnancy test negative at baseline (within 7 days before injection of 99mTc-NTP 15-5). Menopause is defined as amenorrhea for at least 12 consecutive months with no other cause and FSH and oestradiol levels consistent with those of the post-menopausal period.
- •Ability and willingness to respect study visits, exams as well as protocol.
- •certain diagnosis of rheumatoid arthritis less than 5 years old, according to the ACR/EULAR criteria,
- •symptomatic (finger pain > 4 /10 on a numerical scale),
- •active synovitis (clinical and ultrasound),
- •certain diagnosis of symptomatic DOA less than 5 years old (finger pain > 4 /10 on a numerical scale),
- •stopping NSAIDs for at least 8 days before the injection,
排除标准
- •Ongoing use of non-steroidal anti-inflammatory drugs,
- •Treatment by local joint corticoid infiltration at the hand level in the month preceding the administration of 99mTc-NTP 15-5,
- •History of osteoarticular hand surgery.
- •History of hand soft tissue surgery in the past 6 months
- •Patients or patients 18 years old,
- •Pregnant or breastfeeding patient,
- •History of known allergy to excipients contained in the 99mTc-NTP 15-5 solution,
- •Persons deprived of their liberty, under guardianship/curatorship, or safeguarding of justice,
- •Inability to submit to the medical follow-up of the trial for geographical, family, social or psychological reasons. These conditions must be discussed with the patient before registration in the study.
- •Use of biotherapies (anti-TNF alpha, rituximab, abatacept, anti-IL6 and anti-JAK) as background treatment.
- •Patients with a history of hand DOA
研究组 & 干预措施
digital osteoarthritis
Experimental
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)
Rheumatoid arthritis
Experimental
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)
研究者
研究点 (2)
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