PET/CT Imaging Agent for COVID-19

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of California, Davis

Disqualifiers: Pregnancy, Breast-feeding, Obesity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging agent, 18F-αvβ6-BP, to understand its effects on the lungs of people who have recovered from COVID-19. The goal is to determine how this imaging method can study lung changes after the virus. Participants will receive an injection of a special tracer before undergoing a PET/CT scan, which creates detailed pictures of the lungs. The trial seeks individuals who have had COVID-19, tested negative twice since, and had no lung disease before their infection. As an Early Phase 1 trial, this research focuses on understanding how this new imaging agent works in people, offering participants a chance to contribute to groundbreaking medical research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this imaging agent is safe for use in PET/CT scans?

Research has shown that 18F-αvβ6-BP is a new substance being tested for use in PET/CT scans to examine the lungs after a COVID-19 infection. So far, a small number of patients have tried this substance. These early tests suggest it could safely identify changes in the lungs after the virus.

The current information on safety is limited, but no serious side effects have been reported in the patients tested. As this is an early phase trial, researchers focus on ensuring the treatment's safety. Treatments in early stages are generally closely monitored for safety, and any side effects are carefully recorded.

Overall, while more information is needed, early findings suggest that 18F-αvβ6-BP is well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard COVID-19 treatments that focus on reducing symptoms or viral load, the 18F-αvβ6-BP treatment is unique because it uses a PET/CT imaging agent to help visualize the virus's impact on the lungs. Researchers are excited about this treatment because it targets the αvβ6 integrin, offering a new way to assess the disease's progression in real time. This imaging capability could lead to more precise monitoring and faster adjustments in patient care, potentially improving outcomes.

What evidence suggests that this imaging agent is effective for evaluating patients after COVID-19 infection?

Research has shown that 18F-αvβ6-BP, the investigational imaging agent used in this trial, is a promising tool for detecting lung damage in individuals who have had COVID-19. This agent is used with PET/CT scans, advanced types of X-rays. Studies have found that it can help visualize and track changes in the lungs after a COVID infection. It targets a specific protein in the lungs that often increases with damage. Early findings suggest it could be useful for monitoring lung healing over time. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for men and women over 18 who had COVID-19 but are now negative, with no prior lung diseases. They must have had a lung image taken during their infection and be able to stay still for up to an hour per scan. It's not for those with other respiratory infections, pregnant or breastfeeding women, patients too heavy for PET/CT scans (>350lbs), or anyone unlikely to attend follow-up sessions.

Inclusion Criteria

You had a chest X-ray or CT scan while being diagnosed with an infection.

I have been diagnosed with COVID-19.

I can stay still for up to an hour.

Exclusion Criteria

I do not have any active infections in my lungs.

Lack of availability for follow-up assessments

You are expected to live for less than 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants receive a 10 mCi (±20%) intravenous injection of 18F-αvβ6-BP, followed by PET/CT imaging to detect lung damage

6 months

Up to 3 PET/CT scans

Follow-up

Participants are monitored for safety and effectiveness after imaging

6 months

What Are the Treatments Tested in This Trial?

Interventions

• 18F-αvβ6-BP

Trial Overview The study tests a new imaging agent called 18F-αvβ6-binding-peptide in PET/CT scans on patients who've recovered from COVID-19. The goal is to see how well this peptide works in detecting changes in the lungs after SARS-CoV-2 infection.

How Is the Trial Designed?

Group I: 18F-αvβ6-BP Experimental Treatment 1 Intervention

Following a 10 mCi (±20%) intravenous injection (IV) of 18F-αvβ6-BP, PET/CT images will be acquired at 60 minutes. Baseline blood samples will be drawn and banked. Vital sign (VS) measurements (heart rate, respiratory rate, blood pressure and temperature) monitored throughout. Region-of-interest analysis (ROI) will be performed in the lung. Each participant will undergo up to 3 18F- αvβ6-BP PET/CT scans over a 6-month timeframe.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04376593

NCT04376593 | PET/CT Imaging in COVID-19 Patients The goal of the study is to to acquire 18F-αvβ6-BP PET/CT images in patients diagnosed with SARS CoV2 and to demonstrate the ability of 18F-αvβ6-BP to detect ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8679627/

αvβ6-Targeted Molecular PET/CT Imaging of the Lungs ... 18 F-α v β 6 -BP PET/CT is a promising noninvasive approach to identify the presence and potentially monitor the persistence and progression of lung damage.

3. researchgate.net researchgate.net/figure/F-avb6-BP-PET-CT-images-of-a-COVID-19-recovered-patient-2months-after-infection-Axial_fig5_351710086

¹⁸F-αvβ6-BP PET/CT images of a COVID-19-recovered ... Conclusion These findings suggest that PMMA biocontainment vessels have small but measurable impact on preclinical PET system performance, making them a viable ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8134823/

Positron emission tomography in the COVID-19 pandemic era 18F-αvβ6-BP PET/CT images of a COVID-19-recovered patient 2 months after infection. Axial CT (left), 18F-αvβ6-BP PET (middle), and fused PET/CT ...

5. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2021.568959/full

Identify. Quantify. Predict. Why Immunologists Should ... ... αvβ6-targeted 18F-αvβ6-BP PET with lung damage identified by CT. The authors concluded in-vivo integrin imaging to be a promising strategy to detect and ...

6. jnm.snmjournals.org jnm.snmjournals.org/content/jnumed/61/12/1717.full.pdf

avb6-Targeted Molecular PET/CT Imaging of the Lungs ... This is the first case report of a patient included in the 18F-avb6-BP PET/CT COVID-19 imaging trial (ClinicalTrials.gov NCT04376593). The study ...

7. jnm.snmjournals.org jnm.snmjournals.org/content/61/12/1717

Targeted Molecular PET/CT Imaging of the Lungs After SARS ... This case suggests that 18F-αvβ6-BP PET/CT is a promising noninvasive approach to identify the presence and potentially monitor the persistence ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8155634/

Identify. Quantify. Predict. Why Immunologists Should Widely ... The authors summarize current knowledge for medical imaging in COVID-19 in general with a focus on molecular imaging technology and provide a perspective for ...

9. chemistry-europe.onlinelibrary.wiley.com chemistry-europe.onlinelibrary.wiley.com/doi/pdf/10.1002%2Fcbic.202100209

αVβ6 Integrin: An Intriguing Target for COVID-19 and Related ... The authors have already scheduled [18F]-αVβ6-BP PET/CT scans for 3 and 6 months, and 10 patients will be enrolled in the study. This follow-up ...