DECRYPT: Low-field Magnetic Resonance Imaging of Pediatric COVID-19

Sponsor
University of Erlangen-Nürnberg Medical School (Other)
Overall Status
Recruiting
CT.gov ID
NCT04990531
Collaborator
(none)
58
Enrollment
1
Location
1
Arm
3.7
Anticipated Duration (Months)
15.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

SARS-CoV-2 (Severe acute respiratory syndrome coronavirus type 2) is a new coronavirus and identified causative agent of COVID-19 disease. They predominantly cause mild colds but can sometimes cause severe pneumonia. The long-term consequences are still largely unexplained and misunderstood, especially in children and adolescents. The aim of this study is to assess the frequency of pulmonary skeletal changes in pediatric and adolescent patients using low-field magnetic resonance imaging (LF-MRI) in the setting of proven past SARS-CoV-2 infection.

Condition or DiseaseIntervention/TreatmentPhase
  • Diagnostic Test: Low-field magnetic resonance imaging
N/A

Detailed Description

SARS-CoV-2 (Severe acute respiratory syndrome coronavirus type 2) is a new coronavirus and identified causative agent of COVID-19 disease. They predominantly cause mild colds, but can sometimes cause severe pneumonia. While the molecular basis for the changes in lung tissue or multi-organ involvement has been described, the age-specific long-term consequences, especially in children and adolescents, are still largely unexplained and not understood. Early publications from the primarily affected Chinese provinces described rather mild, partly asymptomatic courses in children. This is consistent with the observation that the risk of severe COVID-19 disease increases steeply from the age of 70 years, and is also determined by the severity of obesity and other risk factors. Developmental expression of tissue factors may be one reason for the relative protection of younger patients from severe courses of the disease.

However, it is now becoming increasingly clear that some individuals with milder initial symptoms of COVID-19 may suffer from variable and persistent symptoms for many months after initial infection - this includes children. A modern low-field MRI is located in Erlangen, Germany. This technique has already been used to demonstrate persistent damage to lung tissue in adult patients after COVID-19. The device with a field strength of 0.55 Tesla (T) currently has the world's largest bore (and is thus particularly suitable for patients with claustrophobia, among other things), a very quiet operating noise, and lower energy absorption in the tissue due to the weaker magnetic field than MRI scanners with 1.5T or 3T. This allows MRI imaging in a very wide pediatric population without the need for sedation.

The purpose of this study is to assess the frequency of lung parenchymal changes using low-field magnetic resonance imaging (LF-MRI) in pediatric and adolescent patients with past SARS-CoV-2 infection detected by PCR.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
58 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Low-fielD magnEtiC Resonance Imaging of pulmonarY Parenchyma Changes Associated wiTh Confirmed SARS-CoV-2 Infection in Children and Adolescents
Actual Study Start Date :
Aug 9, 2021
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

ArmIntervention/Treatment
Other: Low-field magnetic resonance imaging

Label-free low-field magnetic resonance imaging (0.55 Tesla)

Diagnostic Test: Low-field magnetic resonance imaging
Imaging of lung parenchyma by LF-MRI

Outcome Measures

Primary Outcome Measures

  1. Low-field magnetic resonance imaging [Single time point (1 day)]

    Lung parenchymal changes (Ground-glass opacification/opacity (GGO))

Secondary Outcome Measures

  1. Blood sample: Serum [Single time point (1 day)]

    Antibodies against SarS-CoV-2

  2. Blood sample: Leucocytes [Single time point (1 day)]

    Physical properties of single cells: Deformation

  3. Blood sample: Leucocytes [Single time point (1 day)]

    Physical properties of single cells: Cells size [µm³]

  4. Blood sample: Leucocytes [Single time point (1 day)]

    Physical properties of single cells: Youngs modulus [kPa³]

  5. Blood sample: Erythrocytes [Single time point (1 day)]

    Physical properties of single cells: Deformation

  6. Blood sample: Erythrocytes [Single time point (1 day)]

    Physical properties of single cells: Cells size [µm³]

  7. Blood sample: Erythrocytes [Single time point (1 day)]

    Physical properties of single cells: Youngs modulus [kPa³]

  8. Blood sample: Monocytes [Single time point (1 day)]

    Physical properties of single cells: Deformation

  9. Blood sample: Monocytes [Single time point (1 day)]

    Physical properties of single cells: Cells size [µm³]

  10. Blood sample: Monocytes [Single time point (1 day)]

    Physical properties of single cells: Youngs modulus [kPa³]

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • (Past) Positive SARS-CoV-2 Infection (PCR proven)

  • Age 5 to <18 years

Exclusion Criteria:
  • Acute SARS-CoV-2 Infection and Isolation

  • Quarantine

  • Pregnancy

  • Critical Illness

  • No consent to LF_MRI

  • General contraindications for LF-MRI, such as electrical implants, pace makers, perfusion pumps)

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Department of Pediatrics and Adolescent MedicineErlangenBavariaGermany91054

Sponsors and Collaborators

  • University of Erlangen-Nürnberg Medical School

Investigators

  • Principal Investigator: Ferdinand Knieling, MD, Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT04990531
Other Study ID Numbers:
  • 206_21 B
First Posted:
Aug 4, 2021
Last Update Posted:
Sep 14, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 14, 2021