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RecruitingPhase 3

Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) PET/CT Imaging

Evaluation of Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74 PET/CT Imaging)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 100 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 6 visits
  • Time periods mentioned: 2 years, 12 months
  • Procedures mentioned: Blood draws, MRI scans, CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Design: Participants will have 6 clinic visits over 2 years."
  • "Participants will be screened: They will have blood tests and tests of their heart and lung function."
  • "Those with heart disease will have a magnetic resonance imaging (MRI) scan of the heart."
  • "The study tracer will be used with positron emission tomography (PET)/computed tomography (CT) scans."
  • "They will also have standard CT scans and blood tests during these visits."
  • "They will also have blood tests at 3 and 6 months between these visits."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a new radioactive tracer called 18F-FAPI-74, given by vein during PET/CT scans, to help find early signs of scarring. It is for adults with heart, lung, or blood vessel disease that may cause scar tissue. Participants will have 6 clinic visits over 2 years.

Background: Injury or diseases of the heart and lung can sometimes cause scar tissue (fibrosis) to build up in those organs. Current imaging scans can see this scar tissue once it has formed, but researchers want to find a way to detect the fibrosis in its earliest stages, while there might still be time to prevent serious damage. A new tracer (a radioactive substance injected during imaging scans) may be able to help. Objective: To test a new tracer (18F-FAPI-74) during imaging scans in people with heart or lung disease. Eligibility: People aged 18 years and older with lung or heart disease that may cause scarring in those organs. Design: Participants will have 6 clinic visits over 2 years. Participants will be screened: They will have blood tests and tests of their heart and lung function. Those with heart disease will have a magnetic resonance imaging (MRI) scan of the heart. The study tracer will be used with positron emission tomography (PET)/computed tomography (CT) scans. The study tracer will be injected into a vein in the arm. Participants will lie on a padded bed that slides through a donut-shaped machine. Participants will have scans with the study tracer 2 times, 8 to 12 months apart. They will also have standard CT scans and blood tests during these visits. They will also have blood tests at 3 and 6 months between these visits. Participants will have a follow-up visit after 18 to 24 months. The study scans, MRI and standard CT scans, and lung function tests may be repeated....

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Understand the study and sign and date a consent form.
  • Be willing to follow all study steps and attend visits for the full study.
  • Have a diagnosed heart, lung, or blood vessel disease that causes scarring or puts you at risk for it.
  • Have had a chest CT scan showing your lungs, heart, or blood vessels.
  • Be able to lie on the PET/CT scanner for up to 45 minutes.
  • If you can become pregnant, use highly effective birth control for at least 1 month before screening, during the study, and for 4 weeks after the FAPI or FDG PET/CT scan.
  • If you can father a child, use condoms or another effective birth control method with your partner during the study and for 4 weeks after the FAPI or FDG PET/CT scan.

Who can't join

  • Have had an allergic reaction to substances like 18F-FAPI-74 or other substances used in the study.
  • Have an uncontrolled illness or other personal or social issues that would prevent you from following study requirements.
  • Are pregnant or breastfeeding.
  • Can become pregnant or are trying to father a child, but will not use effective birth control during the study and for 4 weeks after the last FAPI or FDG PET/CT scan.
  • Have a severe fear of enclosed spaces that does not improve with medicine taken by mouth.
  • Weigh more than 350 pounds or cannot fit inside the scanner.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* INCLUSION CRITERIA In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Participant \>=18 years old 4. Has a specific diagnosis of a cardiopulmonary and/or vascular disease that puts them at risk of developing or having developed tissue fibrosis. 5. Has undergone prior imaging of lungs, heart, and/or vasculature with chest CT 6. Able to lie on the PET/CT scanner for imaging up to 45 minutes. 7. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of FAPI-PET/CT or the FDG PET/CT scan. 8. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional 4 weeks after the end of FAPI-PET/CT or the FDG PET/CT scan. 9. Ability of subject to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA An individual who meets any of the following criteria will be excluded from participation in this study: 1. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-FAPI-74 or other agents used in the study. 2. Uncontrolled intercurrent illness, factors, or social situations that would limit compliance with study requirements 3. Pregnancy or lactation 4. Women able to become pregnant or men actively trying to father a child and are unwilling to use an effective form of birth control during the study and 4 weeks after the last 18F-FAPI-74 PET/CT scan or the FDG PET/CT scan. 5. Subjects with severe claustrophobia unresponsive to oral anxiolytics. 6. Subjects weighing \> 350 lbs (weight limit for PET scanner table), or unable to fit within the imaging gantry

Study sites (1)

MD