IT2023-08-ATKINS-ATHERO-RT: Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Feasibility of using F-NaF PET/MRI imaging
研究概览
简要总结
The prospective single-arm pilot study, ATHERO-RT: Real-Time Atherosclerosis Activity after Thoracic Radiotherapy using Sodium Fluoride Positron Emission Tomography, will aim to:
- To deploy first-in-kind application of fluorine 18-sodium fluoride (18F-NaF) PET (Positron Emission Tomography) /MRI (Magnetic Resonance Imaging) imaging to detect real-time atherosclerosis activity at the time of cancer diagnosis and after cardiac radiation exposure
- To detect longitudinal changes in clonal hematopoiesis (CH) genetic architecture following thoracic RT (Radiation Therapy) in patients at high risk of cardiac dysfunction, and
- To measure perturbations in the immune-modulatory and metabolic states following thoracic RT (Radiation Therapy) exposure in patients at high risk of cardiac dysfunction.
Eligible patients will be adults (≥18 years old) with Stage II-III or oligo-metastatic stage IV malignancy (any histology) at high risk for RT-associated cardiac toxicity (defined as receiving ≥30 Gy (Gray) RT where the heart is in the treatment field54). The study will enroll a total of 10 subjects, recruited from Cedars-Sinai Medical Center. The primary endpoint will be successful completion of 18F-NaF PET imaging at the baseline and 6-month post-RT time points. Blood will be collected at baseline, end of RT, and 6-months post-RT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Age ≥ 18 years.
- •Have clinical stage II-III or oligo-metastatic stage IV malignancy (any histology) planned to be treated with thoracic radiotherapy (≥30 Gy) where the heart is in the treatment field.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-
- •Planning to receive standard of care radiotherapy treatment.
- •Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
- •Ability to read, write, and understand English
排除标准
- •Estimated glomerular filtration rate (eGFR) <45 mL/min/m2 or serum creatinine ≥1.5 mg/dL.
- •Patients with a known or previous allergy to iodinated contrast, gadolinium contrast, and/or 18F-NaF tracer.
- •Inability to receive PET tracer.
- •Inability to receive MRI, requiring sedation for MRI, or prohibitive implant and/or device, including ferromagnetic implants and ferromagnetic foreign bodies.
- •Subjects with claustrophobia, problems being in enclosed spaces, or inability to lie supine.
- •Subjects that are pregnant or breastfeeding.
- •Subjects unable to comply with visit instructions, including inability to lie still, hold breathe, or follow procedure instructions.
- •Allergy to animal dander or animal-instigated asthma.
- •Any other condition which, in the opinion of the investigator, may make the patient a poor candidate for participation in a clinical trial
研究组 & 干预措施
Single Arm
Fluorine-18-sodium fluoride (18F-NaF) PET/MRI imaging with CT angiography
干预措施: CT Angiogram (Diagnostic Test)
Single Arm
Fluorine-18-sodium fluoride (18F-NaF) PET/MRI imaging with CT angiography
干预措施: 18-F-NaF Cardiac PET/MRI and (Diagnostic Test)
结局指标
主要结局
Feasibility of using F-NaF PET/MRI imaging
时间窗: 6 Months
To determine the feasibility of using 18F-NaF PET/MRI imaging for detection of real-time atherosclerosis activity in patients at high risk of RT-associated cardiac dysfunction.
次要结局
- Incidence of MACE(One Year)
研究者
Katelyn Atkins
Sponsor-Investigator
Cedars-Sinai Medical Center