2025-523650-14-00招募中2 期
functional imaging of digital osteoarthritis and rheumatoid arthritis using 99mTc-NTP15-5 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5月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The diagnostic accuracy of 99mTc-NTP 15-5 imaging in detecting an abnormal joint among the 15 joints of the hands. The scintigraphic analysis of the joints will be visual, blinded to the pathology, and binary in nature. A joint will be considered pathological on 99mTc-NTP 15-5 in the event of abnormal tracer uptake, compared to joints with physiological uptake. The diagnosis of a pathological joint (gold standard) will be based on a composite radiological-clinical analysis.
研究概览
简要总结
to evaluate the performance of 99mTc-NTP 15-5 to identify a pathological hand joint in each group: digital osteoarthritis (DOA) and rheumatoid arthritis (RA)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Both Groups : Karnofsky Index > 70%
- •DOA Group : stopping NSAIDs for at least 8 days
- •Both groups: Obtaining written, signed and dated informed consent
- •Both groups: Affiliation to a health insurance plan
- •Both groups : For women of childbearing age (fertile, after menarche and until postmenopausal unless sterile after surgery) including on a GnRH agonist for ovarian suppression: serum pregnancy test negative at baseline (within 7 days prior to injection of 99mTc-NTP 15-5). Menopause is defined as amenorrhea for at least 12 consecutive months without any other cause and FSH and oestradiol levels consistent with those of the post-menopausal period.
- •Both groups : Ability and willingness to comply with clinic visits, tests, and the protocol
- •RA Group : certain diagnosis of rheumatoid arthritis less than 5 years old, according to the ACR/EULAR criteria
- •RA Group : symptomatic (finger pain > 4 /10 on a numerical scale)
- •RA Group :active synovitis (clinical and ultrasound)
- •DOA Group : certain diagnosis of symptomatic DOA less than 5 years old (finger pain > 4 /10 on a numerical scale)
排除标准
- •Both Groups : Ongoing NSAID usage
- •Both groups : Inability to undergo the trial’s medical follow-up due to geographical, family, social, or psychological reasons. These conditions must be discussed with the patient prior to enrollment in the study.
- •RA Group : Use of biotherapies (anti-TNF alpha, rituximab, abatacept, anti-IL6 and anti-JAK) as background treatment
- •RA Group : Patients with a history of hand AD
- •Both groups : Treatment by local joint corticosteroid infiltration at the hand level in the month preceding the administration of 99mTc-NTP 15-5
- •Both groups : History of osteoarticular surgery on the hands
- •Both groups : History of soft tissue surgery on the hands within the past 6 months
- •Both groups : Patients under the age of 18 years old
- •Both groups : Pregnant or breastfeeding patients
- •Both groups : BMI > 30
- •Both groups : History of known allergy to the excipients contained in the 99mTc-NTP 15-5 solution
- •Both groups : Individuals deprived of their liberty, under guardianship/curatorship, or subject to judicial protection
研究组 & 干预措施
99mTc NTP15-5
Test
干预措施: 99mTc NTP15-5 (Drug)
结局指标
主要结局
The diagnostic accuracy of 99mTc-NTP 15-5 imaging in detecting an abnormal joint among the 15 joints of the hands. The scintigraphic analysis of the joints will be visual, blinded to the pathology, and binary in nature. A joint will be considered pathological on 99mTc-NTP 15-5 in the event of abnormal tracer uptake, compared to joints with physiological uptake. The diagnosis of a pathological joint (gold standard) will be based on a composite radiological-clinical analysis.
The diagnostic accuracy of 99mTc-NTP 15-5 imaging in detecting an abnormal joint among the 15 joints of the hands. The scintigraphic analysis of the joints will be visual, blinded to the pathology, and binary in nature. A joint will be considered pathological on 99mTc-NTP 15-5 in the event of abnormal tracer uptake, compared to joints with physiological uptake. The diagnosis of a pathological joint (gold standard) will be based on a composite radiological-clinical analysis.
次要结局
- Performance measures of 99mTc-NTP 15-5 imaging for distinguishing between DAO and RA. Readers will classify the scintigrams as DAO or RA based on the uptake pattern. A consensus will be sought in cases of disagreement. The gold standard will be the diagnosis determined by radioclinical analysis.
- Performance measures for 99mTc-NTP 15-5 imaging to detect an affected joint complex, including: - For RA: MCP joints of the 2nd–5th fingers and IP joints of the 2nd–5th fingers - For DOA: CMC joints of the 2nd–5th fingers, IP joints of the 2nd–5th fingers, and 1R (CMC, MCP, and IP joints of the 1st finger)
- The proportion of joints classified as pathological, according to the scintigraphic method and the radiographic-clinical method.
- Measurements of the radial joint-diaphysis ratio (99mTc-NTP 15-5J/D) determined by semi-automatic tracing of joint interfaces on scintigraphic images and manually traced spherical regions of interest on the radial diaphyses
- Inter-observer reproducibility measures: Cohen’s kappa coefficient for visual readings (prior to consensus) and ICC for quantitative readings.
- All skeletal joints other than the hands will be rated by a score identical to that used during phase I: 0: no fixation, 1: fixation < adjacent diaphysis, 2: fixation = adjacent diaphysis, 3: fixation > adjacent diaphysis
- Adverse events classified according to the NCI-CTCAE V5.0 criteria and associated with 99mTc-NTP 15-5 occurring within one week of injection
研究者
Emilie THIVAT
Scientific
Centre Jean Perrin
研究点 (2)
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