A Phase 2 interventional study of [¹⁸F]AlF-NOTA-FAPI-04 in Nonischemic Cardiomyopathy, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Peking Union Medical College Hospital · Phase 2, Interventional, and Diagnostic
This study aims to evaluate the clinical value of [¹⁸F]AlF-NOTA-FAPI-04 PET/CT for the noninvasive assessment of myocardial fibroblast activation in patients with nonischemic cardiomyopathy. The study will investigate whether [¹⁸F]AlF-NOTA-FAPI-04 PET/CT can provide complementary information for disease phenotyping, assessment of treatment response, and prognostic risk stratification in nonischemic cardiomyopathy.
Nonischemic cardiomyopathy comprises a heterogeneous group of myocardial disorders with variable etiologies, imaging phenotypes, treatment responses, and clinical outcomes. Despite advances in guideline-directed medical therapy, adverse myocardial remodeling and progressive heart failure remain important causes of morbidity and mortality in this population. Activated cardiac fibroblasts are key effector cells in adverse remodeling and extracellular matrix deposition. However, conventional imaging modalities primarily characterize cardiac structure, function, and established tissue injury and do not directly assess ongoing fibroblast activation.
Fibroblast activation protein (FAP) is expressed by activated fibroblasts during tissue remodeling but is minimally expressed in normal myocardium. Positron emission tomography/computed tomography (PET/CT) using the radiotracer [18F]AlF-NOTA-FAPI-04 may therefore provide a noninvasive method for visualizing and quantifying active myocardial fibroblast-related processes. Previous studies have suggested that myocardial FAPI uptake in nonischemic cardiomyopathy may be diffuse, focal, or focal-on-diffuse, may show preferential involvement of specific myocardial regions, and may occur both within and outside areas of late gadolinium enhancement. These findings indicate that FAPI PET and cardiac magnetic resonance imaging may provide complementary information on active fibroblast biology and established myocardial tissue abnormalities.
The study will evaluate whether baseline myocardial FAPI uptake patterns and quantitative parameters are associated with cardiac function, CMR tissue characteristics, subsequent treatment response, and clinical outcomes. It will further explore whether [18F]AlF-NOTA-FAPI-04 PET/CT provides incremental phenotypic and prognostic information beyond conventional clinical and cardiac imaging assessments. The overall objective is to determine the potential role of FAPI PET/CT as a noninvasive molecular imaging tool for disease phenotyping, treatment monitoring, and prognostic risk stratification in nonischemic cardiomyopathy.
Peking Union Medical College Hospital is the lead sponsor of 1,148 studies on the registry; 474 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Nonischemic cardiomyopathy participants receive \[¹⁸F\]AlF-NOTA-FAPI-04 for PET imaging to explore the distribution patterns and clinical potential value.
Drug: [¹⁸F]AlF-NOTA-FAPI-04
An I.V. bolus injection of up to 10 millicurie (mCi) \[¹⁸F\]AlF-NOTA-FAPI-04 will be administered, followed by a PET/CT scan.
Myocardial distribution patterns and quantitative uptake of [¹⁸F]AlF-NOTA-FAPI-04
Myocardial \[¹⁸F\]AlF-NOTA-FAPI-04 uptake will be visually classified according to prespecified distribution patterns, including absent, focal, diffuse, and focal-on-diffuse uptake. Quantitative PET/CT parameters will include myocardial maximum standardized uptake value (SUVmax), mean standardized uptake value (SUVmean), target-to-background ratio using the blood pool as the reference tissue, and prespecified measures of the volume and total extent of abnormal myocardial uptake. The proportion of participants exhibiting each uptake pattern and the distribution of quantitative uptake parameters will be reported in participants with nonischemic cardiomyopathy.
Time frame: Through study completion, an average of 3 months
Correlation between myocardial [¹⁸F]AlF-NOTA-FAPI-04 uptake and cardiac magnetic resonance tissue characteristics
The correlations between myocardial \[¹⁸F\]AlF-NOTA-FAPI-04 PET/CT parameters and cardiac magnetic resonance tissue characteristics will be evaluated. Cardiac magnetic resonance parameters will include measurement of cardiac function, ventricular strain, native T1, ECV, and T2, which were semi-automatically measured using cvi42 software. Standard parameters of cardiac structure and function were calculated by contouring the endocardium and epicardium on long- and short-axis cine images at the end-systolic and -diastolic phases. Native T1 and T2 values were measured on three short axis stacks by contouring the endocardium and epicardium, with stable intra- and inter-observer reliability. ECV values were obtained from pre- and post-contrast T1 maps indexing for hematocrit. Regional associations between myocardial FAPI uptake and corresponding cardiac magnetic resonance abnormalities will also be evaluated using a segment-based analysis.
Time frame: Cardiac magnetic resonance imaging performed within 30 days before or after the baseline PET/CT examination
Correlation between myocardial [¹⁸F]AlF-NOTA-FAPI-04 uptake and cardiac functional parameters by echocardiography
The associations between myocardial \[¹⁸F\]AlF-NOTA-FAPI-04 PET/CT parameters and cardiac functional parameters assessed by echocardiography will be evaluated.
Time frame: Echocardiography performed within 30 days before or after the baseline PET/CT examination
Change in Myocardial [18F]AlF-NOTA-FAPI-04 SUVmax from baseline to 12 months
In the prespecified subset of participants undergoing follow-up \[18F\]AlF-NOTA-FAPI-04 PET/CT, myocardial SUVmax will be measured at baseline and 12 months after the initiation or optimization of standard-of-care treatment.
Time frame: From baseline to 12 months after initiation or optimization of treatment
Change in Myocardial [18F]AlF-NOTA-FAPI-04 SUVmean from baseline to 12 months
In the prespecified subset of participants undergoing follow-up \[18F\]AlF-NOTA-FAPI-04 PET/CT, myocardial SUVmean will be measured at baseline and 12 months after the initiation or optimization of standard-of-care treatment.
Time frame: From baseline to 12 months after initiation or optimization of treatment
Change in Myocardial [18F]AlF-NOTA-FAPI-04 SUVR from baseline to 12 months
In the prespecified subset of participants undergoing follow-up \[18F\]AlF-NOTA-FAPI-04 PET/CT, myocardial SUVR will be measured at baseline and 12 months after the initiation or optimization of standard-of-care treatment.
Time frame: From baseline to 12 months after initiation or optimization of treatment
Change in Myocardial [18F]AlF-NOTA-FAPI-04 myocardial uptake volume from baseline to 12 months
In the prespecified subset of participants undergoing follow-up \[18F\]AlF-NOTA-FAPI-04 PET/CT, myocardial uptake volume will be measured at baseline and 12 months after the initiation or optimization of standard-of-care treatment.
Time frame: From baseline to 12 months after initiation or optimization of treatment
Change in Myocardial [18F]AlF-NOTA-FAPI-04 total extent of myocardial uptake from baseline to 12 Months
In the prespecified subset of participants undergoing follow-up \[18F\]AlF-NOTA-FAPI-04 PET/CT, total extent of myocardial uptake will be measured at baseline and 12 months after the initiation or optimization of standard-of-care treatment.
Time frame: From baseline to 12 months after initiation or optimization of treatment
All-cause mortality
All-cause mortality is defined as death from any cause during follow-up. Time to death will be calculated from the date of the baseline \[¹⁸F\]AlF-NOTA-FAPI-04 PET/CT examination to the date of death. Participants who remain alive will be censored at the date of their last confirmed follow-up.
Time frame: Up to 36 months after the baseline PET/CT scan
Major adverse cardiovascular events
Major adverse cardiovascular events will be defined as the first occurrence of cardiovascular death, including sudden cardiac death; unplanned hospitalization for worsening heart failure; major ventricular arrhythmia; heart transplantation; or implantation of a durable left ventricular assist device. Major ventricular arrhythmia will be defined as sustained ventricular tachycardia or ventricular fibrillation requiring cardioversion, defibrillation, appropriate implantable cardioverter-defibrillator therapy, or urgent hospitalization. Time to the first event will be calculated from the date of the baseline \[¹⁸F\]AlF-NOTA-FAPI-04 PET/CT examination. The incidence of the composite outcome and each individual component will be reported separately.
Time frame: Up to 36 months after the baseline PET/CT scan
Plan to share: Yes — Available upon request
Supporting information: Study protocol
Time frame: Within 2 years after the publication of the main results
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Dec 2027, 24 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Peking Union Medical College Hospital →