Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04874818
Status:
UNKNOWN
Last Update Posted:
2022-06-07
First Post:
2021-04-28
Brief Title:
CD8 T-cell PETCT Imaging in COVID-19 Patients
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
89ZrDf-IAB22M2C Anti-CD8 Minibody PETCT Imaging to Assess the in Vivo Distribution of CD8 T-cells in COVID-19 Patients
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Tangelo
Brief Summary:
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 CD8 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 89ZrDf-IAB22M2C positron emission tomography PET imaging
Detailed Description:
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 eg 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 89ZrDf-IAB22M2C PETCT 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 89ZrDf-IAB22M2C PETCT 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 10 x10e9L n10 and with lymphocyte numbers within normal range 10 - 35 x10e9L n10
Study procedure All patients will undergo a 89ZrDf-IAB22M2C PETCT scan 21-27 hours post intravenous injection of 15mg protein dose labelled with 37 megabecquerel MBq 1 mCi 89Zr and one additional blood sample at the day of scanning
Primary study objective The primary objective of this study is to assess differences in the in vivo distribution of CD8 T-cells in patients with proven SARS-CoV-2 presenting with lymphopenia or with normal lymphocyte counts using 89ZrDf-IAB22M2C PETCT imaging
Secondary study objectives
1 To assess the spatial correlation between 89ZrDf-IAB22M2C uptake and abnormal findings on routine contrast-enhanced CT scan of the chest
2 To assess the correlation between in vivo biodistribution of 89ZrDf-IAB22M2C and concurrent flowcytometric phenotypic and quantitative assessment of lymphocyte populations
3 To explore the correlation between in vivo biodistribution of 89ZrDf-IAB22M2C and clinical course of disease
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 eg 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 89ZrDf-IAB22M2C PETCT 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 89ZrDf-IAB22M2C PETCT 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 10 x10e9L n10 and with lymphocyte numbers within normal range 10 - 35 x10e9L n10
Study procedure All patients will undergo a 89ZrDf-IAB22M2C PETCT scan 21-27 hours post intravenous injection of 15mg protein dose labelled with 37 megabecquerel MBq 1 mCi 89Zr and one additional blood sample at the day of scanning
Primary study objective The primary objective of this study is to assess differences in the in vivo distribution of CD8 T-cells in patients with proven SARS-CoV-2 presenting with lymphopenia or with normal lymphocyte counts using 89ZrDf-IAB22M2C PETCT imaging
Secondary study objectives
1 To assess the spatial correlation between 89ZrDf-IAB22M2C uptake and abnormal findings on routine contrast-enhanced CT scan of the chest
2 To assess the correlation between in vivo biodistribution of 89ZrDf-IAB22M2C and concurrent flowcytometric phenotypic and quantitative assessment of lymphocyte populations
3 To explore the correlation between in vivo biodistribution of 89ZrDf-IAB22M2C and clinical course of disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-005984-29 | EUDRACT_NUMBER | None | None |