Study on [68Ga]FAPI-46 to Detect Lung Fibroblast Activity in COVID-19 Patients with Long-Term Symptoms

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What is this study about?

This clinical trial is focused on studying the long-term effects of COVID-19, specifically in patients who experience ongoing symptoms like shortness of breath and fatigue, often referred to as “long COVID.” The study will use a special imaging technique called [68Ga]FAPI PET/CT to detect activity in cells called fibroblasts in the lungs. Fibroblasts are involved in the healing process and can sometimes lead to scarring or other changes in the lungs.

The purpose of the study is to determine if there is more fibroblast activity in patients who continue to have symptoms compared to those whose symptoms have resolved. Participants will receive an injection of a solution containing [68Ga]FAPI-46, which helps highlight fibroblast activity during the imaging process. The study will compare the results between different groups of patients, including those with ongoing symptoms and those who have recovered.

Throughout the study, participants will undergo the PET/CT scan and may be asked to complete questionnaires about their health and symptoms. The study aims to provide a better understanding of how long COVID affects the lungs and to explore potential ways to personalize diagnosis and treatment for affected individuals. The study is expected to continue until early 2026.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, self-reported symptoms of breathlessness or tiredness lasting more than three months after a confirmed COVID-19 infection.

The assessment also involves categorizing participants into two groups based on the Fatigue Severity Scale score.

2 preparation for imaging

Participants are prepared for imaging procedures. This involves understanding the process of the [68Ga]FAPI PET/CT scan, which is used to detect fibroblast activity in the lungs.

The imaging procedure is designed to assess lung activity and compare it between those with ongoing symptoms and those whose symptoms have resolved.

3 administration of solution

The [68Ga]FAPI-46 solution is administered intravenously. This solution is specifically prepared for injection to facilitate the imaging process.

The administration is conducted under controlled conditions to ensure safety and accuracy.

4 imaging procedure

The [68Ga]FAPI PET/CT scan is performed to measure pulmonary fibroblast activity. This involves capturing detailed images of the lungs to identify any differences in activity levels.

The scan results are used to evaluate the target to background ratio of the lung and other related metrics.

5 data analysis

Data from the imaging procedure is analyzed to determine the TBRLung differences between groups. This analysis helps in understanding the extent of fibroblast activity.

Secondary analyses include evaluating the uptake of [68Ga]FAPI in relation to various health metrics and biological markers.

6 follow-up

Participants may be required to complete additional questionnaires and undergo further assessments to monitor any changes in symptoms or health status.

The follow-up phase ensures comprehensive data collection and contributes to the overall findings of the study.

Who Can Join the Study?

Must be an adult over 20 years old.
Must have self-reported complaints of dyspnea (difficulty breathing) or fatigue (extreme tiredness) for more than 3 months after a confirmed SARS-CoV-2 infection. This infection should be confirmed by a PCR test, a serology test, or a COVID-19 Reporting and Data System (CO-RADS) score of 4 or 5.
For Group 1: Must have a Fatigue Severity Scale score of 4 or higher at the time of the [68Ga]FAPI PET/CT scan. The Fatigue Severity Scale is a way to measure how severe your fatigue is.
For Group 2: Must have a Fatigue Severity Scale score of less than 4 at the time of the [68Ga]FAPI PET/CT scan, but must have previously recorded a score of 4 or higher, or an equivalent score.
If there are not enough participants for Group 2, ‘Healthy’ controls will be included. These are people without self-reported complaints and no past SARS-CoV-2 infection, which would have resulted in a Fatigue Severity Scale score of less than 4, or people who have not experienced a confirmed SARS-CoV-2 infection.

Who Cannot Join the Study?

Patients who are not experiencing post-acute sequelae of COVID-19, which means ongoing symptoms after recovering from the initial COVID-19 infection, cannot participate.
Patients who do not have long COVID dyspnea, which is difficulty breathing that continues after recovering from COVID-19, are excluded.
Patients who do not have long COVID fatigue, which is ongoing tiredness or exhaustion after recovering from COVID-19, are excluded.
Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups, but the specific ages are not listed here.
Both male and female patients are eligible, so exclusion is not based on gender.
Patients who are considered part of a vulnerable population, which means they might need special protection or care, are not included in this study.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Uoxwmserkhbn Mckmzes Cpplezd Gceldhhhz	Groningen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.01.2025

Trial locations

Investigated drugs:

(S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-Cyano-4,4-Difluoropyrrolidin-1-Yl)-2-Oxoethylcarbamoyl)-Quinolin-6-Yl)(Methyl)Amino)-Propyl)Piperazin-1-Yl)-2-Oxoethyl)-68Ga-[1,4,7,10]-Tetraazacyclododecane-1,4,7-Triyl)Triacetate

[68Ga]FAPI-PET/CT is a type of imaging test used in this study. It helps doctors see how active certain cells, called fibroblasts, are in the lungs. This test is important for understanding if people who have ongoing symptoms after COVID-19, like trouble breathing and feeling very tired, have more active fibroblasts compared to those who have recovered.

Investigated diseases:

Post-acute COVID-19 syndrome

Post-acute sequelae of COVID-19 – This condition, often referred to as long COVID, occurs after the initial recovery from a COVID-19 infection. It is characterized by a range of symptoms that persist for weeks or months beyond the acute phase of the illness. Common symptoms include fatigue, shortness of breath, and cognitive difficulties, often described as “brain fog.” The severity and duration of these symptoms can vary widely among individuals. Some people may experience a gradual improvement over time, while others may have persistent symptoms. The exact cause of these prolonged symptoms is still being studied, with ongoing research into potential underlying mechanisms.

Trial ID:

2024-517931-29-00

Protocol code:

19097

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on [68Ga]FAPI-46 to Detect Lung Fibroblast Activity in COVID-19 Patients with Long-Term Symptoms

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?