210 Participants NeededMy employer runs this trial

18F-FAPI-74 Imaging for Heart and Lung Disease

GY
AF
GY
RM
Overseen ByRosemary McConnell, R.N.
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tracer, 18F-FAPI-74, which might help doctors detect early-stage fibrosis (scar tissue) in the heart and lungs through imaging scans. Early detection of fibrosis could prevent more serious health issues later. The trial seeks individuals 18 and older with heart or lung disease that may lead to scarring and who have had prior imaging of these organs. Participants will visit the clinic six times over two years and undergo various scans and tests. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking medical advancement.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that 18F-FAPI-74, a new imaging tracer, is generally safe for people. Research indicates that this tracer can help doctors detect early signs of scarring in the heart and lungs. Detecting these signs early is crucial, as it might help prevent serious damage later on.

Regarding safety, previous studies have not reported any major side effects from using 18F-FAPI-74. Its similarity to other approved tracers adds confidence about its safety. Although no treatment is completely risk-free, data so far suggests that 18F-FAPI-74 is well-tolerated by patients.12345

Why are researchers excited about this trial?

Researchers are excited about 18F-FAPI-74 imaging for heart and lung diseases because it represents a novel approach to diagnosing and understanding these conditions. Unlike traditional imaging methods like CT or MRI that primarily show anatomical structures, 18F-FAPI-74 targets fibroblast activation protein, which is often present in diseased tissues. This allows for more precise detection of disease activity at the cellular level. By offering a clearer picture of the disease process, this imaging technique could lead to more targeted and effective treatment strategies in the future.

What evidence suggests that this trial's imaging technique could be effective for detecting early-stage fibrosis in heart and lung disease?

This trial will use 18F-FAPI-74 PET imaging to study various heart and lung conditions. Studies have shown that 18F-FAPI-74 is promising in detecting early scar tissue changes in these diseases. For heart issues, research indicates that 18F-FAPI-74 effectively images the activation of cells leading to early scarring. In lung diseases, this tracer has proven more accurate than traditional methods in predicting worsening scarring. For high blood pressure in the lungs, 18F-FAPI-74 PET imaging has emerged as a promising noninvasive tool for early detection of changes. Overall, initial findings suggest that 18F-FAPI-74 may help detect scarring before it causes serious damage, making it a potentially valuable tool for early diagnosis and management. Participants in this trial will undergo FAPI/PET/CT imaging for conditions such as interstitial lung disease, pulmonary arterial hypertension, cardiovascular diseases, and others.12356

Who Is on the Research Team?

AF

Anthony F Suffredini, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Are You a Good Fit for This Trial?

This trial is for adults aged 18 and older who have heart or lung diseases that can cause scarring, such as after a transplant, interstitial lung disease, acute lung injury, pulmonary arterial hypertension, or cardiovascular disease.

Inclusion Criteria

Has undergone prior imaging of lungs, heart, and/or vasculature with chest CT
For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such method during study participation and for 4 weeks after FAPI-PET/CT or FDG PET/CT scan
I can lie still for up to 45 minutes during a scan.
See 6 more

Exclusion Criteria

Uncontrolled intercurrent illness, factors, or social situations limiting compliance with study requirements
Pregnancy or lactation
Women able to become pregnant or men trying to father a child unwilling to use effective birth control during study and 4 weeks after last 18F-FAPI-74 PET/CT or FDG PET/CT scan
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Initial Imaging and Baseline Assessment

Participants undergo initial PET/CT imaging and baseline assessments including blood tests and heart/lung function tests

1 week
1 visit (in-person)

Follow-up Imaging

Participants have follow-up PET/CT imaging and standard CT scans 8 to 12 months after the initial scan

8-12 months
2 visits (in-person)

Interim Monitoring

Participants have blood tests at 3 and 6 months between imaging visits

6 months
2 visits (in-person)

Final Follow-up

Participants have a follow-up visit after 18 to 24 months, with potential repeat of study scans, MRI, and standard CT scans

18-24 months
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • 18F-FAPI-74

Trial Overview

The study is testing a new imaging tracer called 18F-FAPI-74 used during PET/CT scans to detect early signs of organ scarring in the heart and lungs. Participants will receive two scans with this tracer about a year apart.

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Group I: Pulmonary arterial hypertensionExperimental Treatment2 Interventions
Group II: Lung allograft transplantationExperimental Treatment2 Interventions
Group III: Interstitial lung diseaseExperimental Treatment2 Interventions
Group IV: Cardiovascular diseasesExperimental Treatment2 Interventions
Group V: Allogeneic stem cell transplantationExperimental Treatment2 Interventions
Group VI: Acute lung injuryExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials
3,987
Recruited
47,860,000+

Citations

Initial results with [18F]FAPI-74 PET/CT in idiopathic ... - PMC

The initial results confirm our assumption that [ 18 F]FAPI-74 offers a viable non-invasive assessment method for pulmonary fibrotic changes in patients with ...

18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) ...

FAPI labeled with 68Ga or 18F has shown great promise in cancer detection demonstrating high tumor-to-background ratios in patients across a wide array of ...

18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) ...

Researchers believe that [18F]FAPI-74 PET imaging may be able to visualize cancer more effectively than the approved tracers. If so, the new tracer would make ...

Study of 18F-FAPI-74 PET/CT Imaging to Detect Cancer ...

This study is looking at non-small cell lung cancer, which is a type of cancer that affects the lungs. The study will use a substance called [18F]FAPI-74, ...

18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) ...

This is a single-site imaging study enrolling participants with PDAC, cholangiocarcinoma, HCC, gastric cancer, bladder cancer, ovarian cancer, pheochromocytoma/ ...

SOFIE Biosciences Announces First Patient Dosed in [18F] ...

SOFIE Biosciences today announced that the first patient has been dosed in one of its two Phase 3 clinical trials evaluating [18F]FAPI-74, ...