See if 18F-FAPI-74 PET/CT can better detect fibrosis in heart and lung disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 interventional study compares 18F-FAPI-74 PET/CT imaging with standard imaging methods to detect fibrosis in cardiopulmonary conditions. Participants with qualifying heart or lung diseases will undergo up to six visits over two years, including baseline labs, functional tests, and imaging with the study tracer. Exploratory analyses will examine proteomic, transcriptomic, and metagenomic data from blood and tissue to understand mechanisms and biomarkers of active fibrosis, alongside low-field MRI assessments. The trial is led by NHLBI with sites at the NIH Clinical Center in Bethesda, and aims to quantify concordance between FAPI and standard imaging to guide future diagnostic and monitoring strategies.

Why it matters

Who can join: the full rules

* 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

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Anthony F Suffredini, M.D. — National Heart, Lung, and Blood Institute (NHLBI)
• Study coordinator: Rosemary McConnell, R.N.
• Email: rosemary.mcconnell@nih.gov
• Phone: (301) 827-9716

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Inhaled mosliciguat for pulmonary hypertension in interstitial lung disease (PH-ILD) patients

  This study tests inhaled mosliciguat versus placebo in people with PH-ILD to see if it helps with their condition.

  Recruiting at 3 sites Phase 3 Pulmovant, Inc. · Kissimmee, Florida and 2 other locations · NCT07816185

• Using breath analysis to identify multiple lung diseases

  This study is testing if analyzing breath samples can help identify different lung diseases like lung cancer and COPD in a large group of 10,000 people.

  Recruiting ChromX Health · Guangzhou, Guangdong · NCT06528418

• Registry for patients with fibrotic interstitial lung disease in Taiwan

  This study is collecting health information from patients with fibrotic interstitial lung disease in Taiwan to see how they do over time and how well different treatments work.

  Recruiting Taichung Veterans General Hospital · Taichung · NCT06476470

• Identifying lung disease signatures using advanced MRI techniques

  This study is testing a new MRI technique to see if it can help identify which patients with pulmonary hypertension might benefit from specific treatments.

  Recruiting Phase 2 Duke University · Durham, North Carolina · NCT04778046

• Abnormal menstrual bleeding in women on antithrombotic drugs after heart surgery

  This study looks at whether women on blood thinners after heart surgery have abnormal menstrual bleeding and what factors might put some at higher risk.

  Recruiting Shanghai Zhongshan Hospital · Shanghai, Shanghai Municipality · NCT07870941

• AI-powered ECG to help diagnose and predict outcomes in heart disease

  Researchers test an AI-enhanced ECG to help diagnose and predict outcomes for people with cardiovascular diseases.

  Recruiting Inha University Hospital · Incheon, Incheon · NCT07856472

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.