18F-FAPI-74 Imaging for Heart and Lung Disease
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Imaging and Baseline Assessment
Participants undergo initial PET/CT imaging and baseline assessments including blood tests and heart/lung function tests
Follow-up Imaging
Participants have follow-up PET/CT imaging and standard CT scans 8 to 12 months after the initial scan
Interim Monitoring
Participants have blood tests at 3 and 6 months between imaging visits
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
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
Pulmonary arterial hypertension undergoing FAPI/PET/CT
Lung allograft transplantation undergoing FAPI/PET/CT
Interstitial lung disease undergoing FAPI/PET/CT
Cardiovascular diseases undergoing FAPI/PET/CT
Allogeneic stem cell transplantation undergoing FAPI/PET/CT
Acute lung injury undergoing FAPI/PET/CT
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Heart, Lung, and Blood Institute (NHLBI)
Lead Sponsor
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 ...
4.
clinicaltrials.eu
clinicaltrials.eu/trial/study-of-18f-fapi-74-pet-ct-imaging-to-detect-cancer-spread-in-patients-with-non-small-cell-lung-cancer/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, ...
5.
trialx.com
trialx.com/clinical-trials/listings/293810/18f-fibroblast-activation-protein-inhibitor-2/18F-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/ ...
6.
sofie.com
sofie.com/2025/12/29/sofie-biosciences-announces-first-patient-dosed-in-18ffapi-74-phase-3-study/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, ...
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