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68Ga-FAPI PET/CT to detect ongoing fibroblast activity in post-acute COVID-19 with respiratory impairment after hospital discharge: *The FAPI COVID-CLIMATE Study*

Conditions
pulmonary fibrosis - connective tissue formation in the lungs
10024970
Registration Number
NL-OMON53415
Lead Sponsor
niversitair Medisch Centrum Groningen
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
20
Inclusion Criteria

- Male patients 18 years or older and female patients 20 years or older,
discharged from hospital after PCR-confirmed COVID-19.
- Previous ICU and/or ward admission with high flow nasal oxygen (HFNO) or
mechanical ventilation.
- Persistent respiratory complaints at least 3 months after discharge
(shortness of breath).
- Registered diffusing capacity for carbon monoxide (DLCO) and vital capacity
(VC).

Exclusion Criteria

- Inability or unwilling to give informed consent.
- History of claustrophobia or feeling of inability to tolerate supine position
for the PET/CT scans.
- Severe or significant comorbidityI, defined as COPD GOLD stage II or higher,
known interstitial lung disease and/or an ASA score of IV or higher.
- Women who are pregnant or breastfeeding.

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Fibroblast activity measured by FAPI-PET/CT </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>- Interstitial lung abnormalities (ILA) on high resolution computed tomography<br /><br>(HRCT)<br /><br>- 6-minute walking test (6MWT)<br /><br>- Inflammatory and fibrosis blood markers<br /><br>- Self reported daily impairments (EQ5D questionnaire)</p><br>
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