Nonischemic CardiomyopathyPhase 2FAPI-NICMNCT07878338
FAPI PET Imaging in Nonischemic Cardiomyopathy
A Phase 2 study testing [¹⁸F]AlF-NOTA-FAPI-04 in people with Nonischemic Cardiomyopathy, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Nonischemic Cardiomyopathy
- What is being tested?
- [¹⁸F]AlF-NOTA-FAPI-04
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 2 Dec 2025to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- males or females: age 18-90 years
- with a confirmed diagnosis of nonischemic cardiomyopathy by standard criteria
- must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements
Who cannot join
- coronary atherosclerotic disease (CAD) according to electrocardiogram, coronary artery CTA, or coronary angiography
- pregnancy or breastfeeding
- severe claustrophobia
- inability or refusal of consent
- any condition deemed by the investigator to interfere with study results or increase participant risk
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Peking Union Medical College Hospital, +86 69156874, pumchkyc@126.com
About this study
Official title: Mapping Myocardial Fibroblast Activation With FAPI PET Imaging in Nonischemic Cardiomyopathy
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.
Read the detailed description
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.
- Conditions
- Nonischemic Cardiomyopathy
- Being tested
- [¹⁸F]AlF-NOTA-FAPI-04
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[¹⁸F]AlF-NOTA-FAPI-04Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Nonischemic cardiomyopathy participants | Experimental | Nonischemic cardiomyopathy participants receive [¹⁸F]AlF-NOTA-FAPI-04 for PET imaging to explore the distribution patterns and clinical potential value. Receives: Drug: [¹⁸F]AlF-NOTA-FAPI-04 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Echocardiography performed within 30 days before or after the baseline PET/CT examination
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 36 months after the baseline PET/CT scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start2 Dec 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonischemic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878338
- Sponsor's protocol ID
- FAPI-NICM
- Acronym
- FAPI-NICM
- Status last verified
- Dec 2025
- First submitted
- 17 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available upon request
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping Myocardial Fibroblast Activation With FAPI PET Imaging in Nonischemic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT07878338
- Acronym / sponsor ID
- FAPI-NICM / FAPI-NICM
- Conditions
- Nonischemic Cardiomyopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nonischemic cardiomyopathy participants | Experimental | Drug: [¹⁸F]AlF-NOTA-FAPI-04Nonischemic cardiomyopathy participants receive [¹⁸F]AlF-NOTA-FAPI-04 for PET imaging to explore the distribution patterns and clinical potential value. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- males or females: age 18-90 years
- with a confirmed diagnosis of nonischemic cardiomyopathy by standard criteria
- must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements
Key exclusion criteria (5 listed)
- coronary atherosclerotic disease (CAD) according to electrocardiogram, coronary artery CTA, or coronary angiography
- pregnancy or breastfeeding
- severe claustrophobia
- inability or refusal of consent
- any condition deemed by the investigator to interfere with study results or increase participant risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [¹⁸F]AlF-NOTA-FAPI-04An I.V. bolus injection of up to 10 millicurie (mCi) [¹⁸F]AlF-NOTA-FAPI-04 will be administered, followed by a PET/CT scan. | Drug | Nonischemic cardiomyopathy participants |
Primary outcome
Myocardial distribution patterns and quantitative uptake of [¹⁸F]AlF-NOTA-FAPI-04
Time frame: Through study completion, an average of 3 months
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.
Correlation between myocardial [¹⁸F]AlF-NOTA-FAPI-04 uptake and cardiac magnetic resonance tissue characteristics
Time frame: Cardiac magnetic resonance imaging performed within 30 days before or after the baseline PET/CT examination
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.
Correlation between myocardial [¹⁸F]AlF-NOTA-FAPI-04 uptake and cardiac functional parameters by echocardiography
Time frame: Echocardiography performed within 30 days before or after the baseline PET/CT examination
The associations between myocardial [¹⁸F]AlF-NOTA-FAPI-04 PET/CT parameters and cardiac functional parameters assessed by echocardiography will be evaluated.
7 secondary outcomes
Change in Myocardial [18F]AlF-NOTA-FAPI-04 SUVmax from baseline to 12 months
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
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
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
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
Time frame: From baseline to 12 months after initiation or optimization of treatment
All-cause mortality
Time frame: Up to 36 months after the baseline PET/CT scan
Major adverse cardiovascular events
Time frame: Up to 36 months after the baseline PET/CT scan
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes. Available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [¹⁸F]AlF-NOTA-FAPI-04 in people with Nonischemic Cardiomyopathy, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Huo (+86 18612672038, huoli@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial distribution patterns and quantitative uptake of [¹⁸F]AlF-NOTA-FAPI-04 (time frame: Through study completion, an average of 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.