RDG-PET/CT imaging in COVID-19 patients.

Phase 1

• Conditions: Maximum 10 patients from the Infectious Diseases ward with proven COVID-19 infection and pulmonary abnormalities on contrast-enhanced CT undergo static PET scans after injection of 70 µg (200 MBq) [68Ga]Ga-DOTA-(RGD)2.; MedDRA version: 20.1Level: HLTClassification code 10047468Term: Viral lower respiratory tract infectionsSystem Organ Class: 100000004855; MedDRA version: 21.1Level: LLTClassification code 10038701Term: Respiratory insufficiencySystem Organ Class: 100000004855; MedDRA version: 20.1Level: HLTClassification code 10047483Term: Viral upper respiratory tract infectionsSystem Organ Class: 100000004855; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2020-001325-31-NL
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-07
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• A microbiologically proven SARS-CoV-19 infection;
• Pulmonary involvement as demonstrated on recent (<1 week) chest CT;
• Enrolled in the BioMarCo-19 study (CMO2020-6344);
• More than or equal to 18 years of age;
• Ability to provide written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion Criteria

• Contra-indication for PET:
o Pregnancy;
o Breast-feeding;
o Severe claustrophobia.
• Contra-indication for administration of iodine-containing contrast agents;
• Other serious illness, e.g. history of malignancies
;• Estimated creatinine clearance = 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified