PET Imaging Clinical Trial
— TangeloOfficial title:
[89Zr]Df-IAB22M2C Anti-CD8 Minibody PET/CT Imaging to Assess the in Vivo Distribution of CD8+ T-cells in COVID-19 Patients
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 2022 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: - a microbiologically proven SARS-CoV2 infection - More than 50 years of age; - Ability to provide written informed consent. Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
Netherlands | Radboud university medical center | Nijmegen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Radboud University Medical Center | ImaginAb, Inc. |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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 | 18 months | |
Secondary | Based on imaging | 1) Spatial correlation of SUVmean per lung segment with CORADS score per lung segment | 18 months | |
Secondary | Based on laboratory parameters | 2) In vivo biodistribution of [89Zr]Df-IAB22M2C will be correlated to laboratory test 3) In vivo biodistribution of [89Zr]Df-IAB22M2C will be correlated with lymphocyte counts (x10e9/L) | 18 months | |
Secondary | Based on clinical characteristics | 4) In vivo biodistribution of [89Zr]Df-IAB22M2C will be correlated with duration of hospital stay (days) | 18 months |
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