Application of IV 99mTc-tilmanocept for Imaging of Macrophage-specific Inflammation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Aortic uptake of intravenously administered 99mTc tilmanocept on SPECT/CT
研究概览
简要总结
The purpose of this study is to evaluate uptake of intravenously administered 99mTc-tilmanocept using single photon emission computed tomography (SPECT/CT) scanning in individuals with HIV and individuals without HIV.
详细描述
People living with HIV (PLWH) have an increased risk of cardiovascular disease (CVD) compared to individuals without HIV. Increased systemic immune activation and arterial inflammation are thought to contribute to this increased risk by affecting the highly inflammatory process of atherosclerotic plaque formation and progression. This study will evaluate whether intravenous administration of a macrophage-specific imaging agent, 99mTc-tilmanocept, followed by SPECT/CT scanning can permit quantification of aortic 99mTc-tilmanocept uptake, reflective of aortic macrophage-specific inflammation among participants with HIV. We will also compare aortic 99mTc-tilmanocept uptake in participants with HIV to participants without HIV. Immunology parameters such as markers of immune activation and traditional CVD parameters will be assessed in relation to imaging assessments.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •men and women, ages 18 to 80, with documented HIV infection
- •current use of antiretroviral therapy (ART), with no changes to regimen within last 3 months
排除标准
- •pregnancy or breastfeeding
- •known active opportunistic infection requiring ongoing medical therapy (not including Hepatitis B/C)
- •CD4 count < 50 cells/mm3
- •history of myocardial infarction,acute coronary syndrome, or coronary artery stenting or surgery
- •stable or unstable angina
- •recent and/or current treatment with prescription, systemic steroids or anti-inflammatory/immune suppressant medical therapies
- •current use of statin or use of statin for > 1 month within the last 6 months
- •known allergy to dextrans and/or DTPA and/or radiometals
- •eGFR < 60 ml/min/1.73 m2 calculated by CKD-EPI
- •known severe allergy to iodinated contrast media
- •contraindication to nitroglycerin
- •significant radiation exposure (>2 CT angiograms) received within the past 12 months
- •reported active illicit drug use
- •concurrent enrollment in another research study judged by the study investigators to interfere with the current study
- •Non-HIV-infected participant:
- •Inclusion criteria:
- •men and women, ages 18 to 80, without HIV infection
- •Exclusion Criteria:
- •pregnancy or breastfeeding
- •history of myocardial infarction, acute coronary syndrome, or coronary artery stenting or surgery
- •stable or unstable angina
- •recent and/or current treatment with prescription, systemic steroids or anti-inflammatory/immune suppressant medical therapies
- •current use of statin or use of statin for > 1 month within the last 6 months
- •known allergy to dextrans and/or DTPA and/or radiometals
- •eGFR < 60 ml/min/1.73 m2 calculated by CKD-EPI
- •known severe allergy to iodinated contrast media
- •contraindication to nitroglycerin
- •significant radiation exposure (>2 CT angiograms) received within the past 12 months
- •reported active illicit drug use
- •concurrent enrollment in another research study judged by the study investigators to interfere with the current study
结局指标
主要结局
Aortic uptake of intravenously administered 99mTc tilmanocept on SPECT/CT
时间窗: within 6 weeks of screening visit
次要结局
- Aortic plaque burden and morphology on CT angiography(within 6 weeks of screening visit)
- Inflammatory markers in relation to cardiovascular imaging outcomes(within 6 weeks of screening visit)
- Uptake of intravenously administered 99mTc tilmanocept on SPECT/CT in regions other than the aorta(within 6 weeks of screening visit)
- Traditional markers of cardiovascular disease (CVD) risk in relation to cardiovascular imaging outcomes(within 6 weeks of screening visit)
- Comparison of imaging assessments between HIV-infected participants and non-HIV-infected participants(within 6 weeks of screening visit)
- Imaging assessments of the coronary vasculature(within 6 weeks of screening visit)
研究者
Steven K. Grinspoon, MD
Professor of Medicine, Harvard Medical School
Massachusetts General Hospital