[89Zr]Df-IAB22M2C Anti-CD8 Minibody PET/CT Imaging to Assess the in Vivo Distribution of CD8+ T-cells in COVID-19 Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- The primary objective of this study is to quantify uptake of [89Zr]Df-IAB22M2C, as a surrogate for the presence of CD8+ T-cells, in major organ systems of patients with proven SARS-CoV-2 presenting with lymphopenia or with normal lymphocyte counts.
研究概览
简要总结
A subset of patients diagnosed with severe acute respiratory syndrome (SARS)-CoV2 infection present with lymphopenia. The degree of lymphopenia, and in particular reduced cluster of differentiation (CD)8+ T-cell numbers, is correlated with clinical deterioration and intensive care unit (ICU) admission. The underlying reasons for lymphopenia in coronavirus disease (COVID)-19 is currently unclear, We aim to assess differences in the in vivo distribution of CD8+ T-cells in patients with proven SARS-CoV2 presenting with lymphopenia or with normal lymphocyte counts, using Zirconium-89 ([89Zr])Df-IAB22M2C positron emission tomography (PET) imaging.
详细描述
Rationale: A subset of patients diagnosed with SARS-CoV2 infection present with lymphopenia. The degree of lymphopenia, and in particular reduced CD8+ T-cell numbers, is strongly correlated with clinical deterioration and ICU admission .
The underlying reasons for lymphopenia in COVID-19 is currently unclear, but several hypotheses have been put forward; 1) sequestration of CD8+ T-cells in peripheral tissues (e.g. lung) either during the effector phase of their lifespan or passively by local chemotactic signals, 2) accelerated maturation and apoptosis either induced by storm of inflammatory cytokines or direct infection or 3) resulting from decreased lymphopoiesis induced by reduced levels of stem cell factor. The lack of data on in vivo distribution of CD8+ T-cells hampers a more thorough understanding of this critical prognostic factor.
Aim: We aim to assess differences in the in vivo distribution of CD8+ T-cells in patients with proven SARS-CoV2 presenting with lymphopenia or with normal lymphocyte counts, using [89Zr]Df-IAB22M2C PET/CT imaging.
Study design: This is a prospective, observational non-randomized pilot study in 20 patients with microbiologically proven SARS-CoV2 infection. All patients will undergo a whole body [89Zr]Df-IAB22M2C PET/CT scan.
Study population: Twenty patients ≥50 years of age with proven COVID-19, who are admitted to the ward will be included, patients will be stratified according to lymphocyte counts on admission to ensure an even distribution: presenting with lymphopenia (<1.0 x10e9/L) (n=10) and with lymphocyte numbers within normal range (1.0 - 3.5 x10e9/L) (n=10).
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a microbiologically proven SARS-CoV2 infection
- •More than 50 years of age;
- •Ability to provide written informed consent.
排除标准
- •Contra-indication for PET: Pregnancy, Breast-feeding, Severe claustrophobia.
- •Contra-indication for administration of iodine-containing contrast agents
- •Other serious illness, e.g. history of malignancies or auto-immune disorders
- •Known pre-existing lymphopenia from an unrelated other medical condition
- •Estimated creatinine clearance ≤ 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method) OR oligo-uric patients (<400 mL/24hr)
结局指标
主要结局
The primary objective of this study is to quantify uptake of [89Zr]Df-IAB22M2C, as a surrogate for the presence of CD8+ T-cells, in major organ systems of patients with proven SARS-CoV-2 presenting with lymphopenia or with normal lymphocyte counts.
时间窗: 18 months
The main study parameter is the SUVmean uptake of \[89Zr\]Df-IAB22M2C in major organs systems, e.g. lungs, spleen, bone marrow, liver and bloodpool
次要结局
- Based on clinical characteristics(18 months)
- Based on laboratory parameters(18 months)
- Based on imaging(18 months)