Phase II Investigation of [F-18]MHF as a PET Tracer to Detect Implants-associated Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Number of patients who are positive on [F-18]MHF who also have orthopedic implant-associated infections as established by the standard of truth during surgery
研究概览
简要总结
Following intravenous injection of [F-18]MHF as a bolus, dynamic PET imaging of the lower limbs will be acquired for approximately 90 minutes. The acquired images will be processed and viewed on a MIMVista or similar workstation. The uptake pattern of [F-18]MHF around infected orthopedic knee implant will be determined and compared with its uptake pattern around non-infected knee implants.
This study will look at how [18F]MHF goes into normal knee replacements and those with suspected infection.
详细描述
This is a study that will test a compound (chemical substance) that has a small amount of radioactivity attached to it. This substance has a natural tendency to go to bacterial infections. The substance is called [18F]MHF and it is given in the form of an injection into a vein. After the substance reaches the infected body region, scans called PET or Positron Emission Tomography, are done. This is similar to having CAT scans or x-rays. Usually a compound called [18]FDG is used for PET scans to detect bacterial infections but this substance can't distinguish between bacterial infections and inflammation. This substance called [18F]MHF does not go to inflamed tissue and may allow bacterial infections to be seen better.
This study will look at how [18F]MHF goes into normal knee replacements and those with suspected infection. This will hopefully lead to the development of better imaging techniques to look at bacterial infections. [18F]MHF is approved by the FDA (Food and Drug Administration) for research.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •for symptomatic patient cohort
- •Patients must be 18 years of age or older, able to provide written informed consent, and ability to lie still for PET scanning.
- •Suspected knee prosthetic infection at least 2 months after original prosthesis placement and who are scheduled to undergo surgery debridement/removal based on the clinical assessment of the referring surgeon.
- •OR Inpatients or outpatients with standard clinical evidence of infected left-ventricular assist devices (LVADs), cardiac implantable electronic devices (CIEDs) such as but not restricted to pacemakers and defibrillators, and vascular grafts. Patients may be culture positive or negative, have visual evidence of infection such as frank pus, or classic radiographic evidence of infection on cross sectional imaging and/or FDG PET.
- •Willingness to abstain from sexual activity involving the exchange of body fluid for 24 hours after the administration of [F-18]MHF
- •Elevated CRP and ESR for orthopedic devices.
排除标准
- •for symptomatic patient cohort:
- •Significant comorbidity such as grade ≥3 renal toxicity, septic shock, other condition in which the opinion of the PI, PET scanning would constitute significant risk
- •Inclusion Criteria for asymptomatic cohort:
- •Patients must be 18 years of age or older, able to provide written informed consent and ability to lie still for PET scanning
- •Knee prosthesis in situ without complications for 6 months or longer
- •Exclusion Criteria for asymptomatic cohort:
- •Clinical or laboratory suspicion of knee prosthesis infection
- •Recent (within 3 months) or current treatment for infected knee prosthesis
- •Significant comorbidity such as grade ≥3 renal toxicity, septic shock, or other condition in which the opinion of the PI, PET scanning would constitute significant risk.
研究组 & 干预措施
Arm A: Symptomatic patient cohort
Arm A will consist of 20 patients who have suspected prosthetic infection and who are scheduled to undergo surgery debridement/removal. Also, those with left-ventricular assist devices (LVADs), cardiac electronic devices such as but not restricted to pacemakers and defibrillators, and vascular grafts with high clinical evidence of infection which will be validated by a composite standard of truth.
干预措施: [F-18]MHF (Drug)
Arm B: Asymptomatic patient cohort
Arm B will consist of 10 asymptomatic normal control patients who have remotely placed total knee or hip prosthesis without clinical or laboratory evidence of infection per inclusion criteria.
干预措施: [F-18]MHF (Drug)
结局指标
主要结局
Number of patients who are positive on [F-18]MHF who also have orthopedic implant-associated infections as established by the standard of truth during surgery
时间窗: 2 weeks (14 days) after surgery
Number of patients who are positive on \[F-18\]MHF who also have orthopedic implant-associated infections as established by the standard of truth during surgery
次要结局
- Number of patients who are negative on [F-18]MHF who do not have have orthopedic implant-associated infections as established by the standard of truth during surgery or on clinical examination if surgery not performed.(2 weeks (14 days) after surgery)