Open-label Clinical Trial on the Safety and Efficacy of 18F-sodium Fluoride (NaF) PET Imaging in Patients in Need of a Standard 99mTc Bone Scintigraphy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2,500
- 试验地点
- 2
- 主要终点
- Correlate 18F-NaF PET images with pathology reports
研究概览
简要总结
18F-sodium fluoride (18F-NaF) was already investigated numerous times in the last 40 years as a PET alternative to standard 99m-technetium-derived bone scintigraphy. However, lack of universal tracer availability and higher costs contributed to the failure of 18F-NaF to systematically supplant bone scintigraphy as a standard of care.
Recently, an isotope shortage crisis occurred and evidenced the need to have non-reactor-derived alternatives for many nuclear medicine procedures, including bone scintigraphy. Since 18F-NaF is cyclotron-produced, it could become a necessary alternative to bone scintigraphy in case of another worldwide isotope shortage.
The study aims to evaluate the safety profile of 18F-NaF injection. Moreover, a patient registry will be compiled in order to perform sub-studies on 18F-NaF diagnostic performance on diverse bone and articular diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients for whom a 99mTc-biphosphonate bone scintigraphy is indicated;
- •Pediatric patients for whom a 99mTc-biphosphonate bone scintigraphy is indicated for oncologic or infectious reasons
- •Able to tolerate supine position
- •Written consent
排除标准
- •Healthy subjects
- •Pregnancy
- •Unable of maintaining supine position for more than 15 minutes
- •Refusal to sign the consent form
- •Known allergy or hypersensitivity to 18F-NaF or any of its constituants.
研究组 & 干预措施
18F-NaF eligible patients
Eligibility for 18F-NaF PET scans is the same than for bone scintigraphy routinely prescribed in the clinic.
干预措施: 18F-sodium fluoride (Diagnostic Test)
结局指标
主要结局
Correlate 18F-NaF PET images with pathology reports
时间窗: 17 years
Pathology data from the diverse conditions eligible for the 18F-NaF PET scan will be also monitored when available. Prognostic value from the imaging data will be compared with those obtained from the pathology.
Safety profile of 18F-NaF
时间窗: 17 years
A registry monitoring eventual adverse effects for this radiopharmaceutical agent will be compiled. Usual procedures will be applied to divulgate any serious adverse effects.
Efficacy profile of 18F-NaF compared to 99mTc-biphosphonate bone scintigraphy
时间窗: 17 years
Using the patient registry, and in the eventual sub-studies to come, the diagnostic performance of 18F-NaF-PET will be compared to similar available imaging tests, most notably 99mTc-biphosphonate bone scintigraphy.
次要结局
未报告次要终点
研究者
Dr Éric E Turcotte, MD
Head of clinical research, CIMS, CRCHUS
Centre de recherche du Centre hospitalier universitaire de Sherbrooke