NCT07473102招募中1 期
PET Imaging of MMP Activation in AAA: Clinical Component
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Verification Cu-64RYM2-2 signal in AAA segments. This will be performed by measuring Standard Uptake Values obtained from analysis of the Cu-64RYM2 images, in AAA patients.
研究概览
简要总结
A first-in-human evaluation of [64Cu]-RYM2 with PET/CT will be performed to: a) assess its safety, biodistribution, and radiation dosimetry in normal volunteers (WU) and; b) in AAA patients undergoing surgery (WU and Yale), evaluate radiotracer pharmacodynamics and correlate PET imaging characteristics (WU) with ex vivo tissue measurements (Yale).
详细描述
A first-in-human evaluation of [64Cu]-RYM2 with PET/CT will be performed to: a) assess its safety, biodistribution, and radiation dosimetry in normal volunteers (WU) and; b) in AAA patients undergoing surgery (WU and Yale), evaluate radiotracer pharmacodynamics and correlate PET imaging characteristics (WU) with ex vivo tissue measurements (Yale).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteers
- •No history of claustrophobia or other preventing condition that has previously or would interfere with completion of protocol-specified imaging sessions.
- •Able to comprehend and willing to follow instructions for the study procedures as called for by the protocol.
- •Capable of lying still and supine within the PET/CT scanner for ~1 hour and follow instructions for breathing protocol during the CT portion.
- •No illicit drug use or other inhaled drug use (including pharmacologic agents, recreational agents, or illicit drugs) within the past year.
- •No known history of cardiac, pulmonary, hepatic or renal disease or diabetes
排除标准
- •Healthy Volunteers
- •Inability to receive and sign informed consent;
- •Pregnant (confirmed by urine pregnancy test) and/or breastfeeding
- •Patient with chronic renal disease whose glomerular filtration rate (GFR) is less than 30 mL/min/1.73 m2
- •Patients with an unstable clinical condition that in the opinion of the principal investigators or designee precludes participation in the study.
- •Is deemed likely to be unable to perform all research procedures for any reason, (e.g., subjects unable to lie still or inability to tolerate up to 60 minutes in a supine position with arms up during the PET imaging procedures due to chronic back/shoulder pain or arthritis as assessed by physical examination and medical history).
- •Currently using recreational drugs.
- •Body weight of >300 lbs. (weight limit of the PET table).
- •Currently enrolled in another study using an investigational drug or underwent a study the last year involving investigational use of radiotracers or CT would confound results or with a radiation exposure when combined with this study would be deemed as excessive by the Sponsor-Investigator.
- •Inclusion Criteria: Patients with AAA electively or semi-electively scheduled for surgical repair
- •Men or women 40-80 years of age
- •Willing and able to provide informed consent
- •Medically managed hypertension and hyperlipidemia
- •No history of claustrophobia or other preventing condition that has previously or would interfere with completion of protocol-specified imaging sessions
- •Able to comprehend and willing to follow instructions for the study procedures as called for by the protocol
- •Patients with AAA indicated for surgical repair (5.0 [female] - 5.5cm [male]), incidentally identified large(r) AAAs (>5.5 or 6.0 cm), and rapidly expanding AAAs (> 0.5 cm in 6 months or > 1 cm in 12 months) per Guidelines of the Society for Vascular Surgery.
- •Exclusion Criteria: Patients with AAA electively or semi-electively scheduled for surgical repair
- •Inability to receive and sign informed consent.
- •Currently enrolled in another study using an investigational drug
- •Pregnant (confirmed by urine pregnancy test) and/or breastfeeding
- •Patient with chronic renal disease whose GFR is less than 30 mL/min/1.73 m2
- •Documented allergy to iodinated contrast and/or shellfish
- •Patients with an unstable clinical condition that in the opinion of the principal investigators or designee precludes participation in the study.
- •Inability to tolerate 60 minutes in a supine position with arms down at sides, as necessary for PET/CT.
- •Other conditions such as symptomatic/recently treated coronary disease, cancer requiring oncologic management, or autoimmune/inflammatory diseases (e.g., rheumatoid arthritis or multiple sclerosis).
- •Non-AAA volunteers may not carry a diagnosis of aortoiliac occlusive disease, as documented by their treating vascular surgeon, as significantly progressed atherosclerotic disease may demonstrate exaggerated, associated MMP activity.
研究组 & 干预措施
dosimetry and AAA patients
Other
Patients who have abdominal aortic aneurysm and healthy volunteers
干预措施: Cu-64-RYM2 (Drug)
dosimetry and AAA patients
Other
Patients who have abdominal aortic aneurysm and healthy volunteers
干预措施: PET imaging using Cu-64 (Drug)
结局指标
主要结局
Verification Cu-64RYM2-2 signal in AAA segments. This will be performed by measuring Standard Uptake Values obtained from analysis of the Cu-64RYM2 images, in AAA patients.
时间窗: 2 years
Verification Cu-64RYM-2 signal is present in AAA segment of the abdominal aorta
次要结局
- Cu-64RYM-2 signal is higher(2 years)
研究者
研究点 (1)
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