Cardiovascular Diseases (CVD)NCT07063043
Clinical Research on 68Ga-FAPI PET/CMR in Cardiovascular Diseases
An observational study of Cardiovascular Diseases (CVD), run by Shanghai East Hospital at 1 site in China.
Trial summary
FAP-targeted PET imaging using 68Ga-FAPI enables early detection of myocardial fibrosis. Combined PET/CMR provides comprehensive cardiac assessment without extra radiation. This advanced imaging approach improves diagnosis and personalized treatment for better patient outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases (CVD)
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 31 Dec 2028
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with cardiovascular diseases
Who may be able to join
- Participants must have a confirmed clinical diagnosis of cardiovascular disease by a cardiologist, based on genetic testing, family history, and comprehensive clinical evaluation including physical examination, echocardiography, and when indicated, cardiac MRI findings.
- Age requirement: >18 years.
- Patients should demonstrate stable cardiovascular status without significant changes in symptoms, treatment, or clinical findings for a specified pre-enrollment period.
- Participants must be capable of providing informed consent and willing to adhere to all study requirements, including follow-up procedures.
Who cannot join
- History of malignancy
- Documented cardiovascular diseases, including coronary artery disease, myocardial infarction, or related conditions
- Implanted metallic devices (e.g., pacemakers, aneurysm clips) or other MRI-incompatible medical prostheses
- Claustrophobia
- Pregnancy or lactation
- Known hypersensitivity to gadolinium-based contrast agents
- Renal impairment (eGFR <30 mL/min/1.73m² by CKD-EPI equation)
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
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120
About this study
FAP-targeted PET imaging using 68Ga-FAPI enables early detection of myocardial fibrosis. Combined PET/CMR provides comprehensive cardiac assessment without extra radiation. This advanced imaging approach improves diagnosis and personalized treatment for better patient outcomes.
Read the detailed description
Cardiovascular diseases (CVDs) are among the leading causes of death and disability worldwide. According to statistics from the World Health Organization (WHO), over 17 million people die from CVDs each year, accounting for 31% of global mortality[1]. In China, the incidence and mortality rates of CVDs continue to rise alarmingly. The China Cardiovascular Health and Diseases Report indicates that approximately 300 million Chinese suffer from CVDs, with annual CVD-related deaths exceeding 4 million - representing over 40% of the country's total deaths[2]. These concerning trends highlight CVDs as a major public health crisis demanding urgent attention.
Recent advances in molecular imaging have opened new avenues for CVD diagnosis and management. Fibroblast activation protein (FAP), a type II transmembrane serine protease, shows minimal expression in normal tissues but becomes markedly upregulated in various pathological conditions including malignant tumors, inflammatory diseases, and fibrotic processes[3,4]. Of particular significance is its role in myocardial fibrosis - a key pathological mechanism underlying many CVDs[5]. Current diagnostic methods for myocardial fibrosis remain limited, with histopathology being invasive and conventional imaging techniques like echocardiography and cardiac MR (CMR) only detecting late-stage changes. The emergence of radiolabeled FAP inhibitors (FAPIs) has enabled non-invasive visualization of early myocardial fibrosis, offering unprecedented opportunities for dynamic monitoring of disease progression and treatment response.
The clinical potential of FAPI-based imaging in CVDs is increasingly recognized. Although still in the exploratory phase, studies have consistently demonstrated FAPI uptake in various CVD animal models and human patients, confirming the activation of cardiac fibroblasts and FAP expression across different disease states. This technology provides three key advantages: first, it allows in vivo visualization of fibroblast activity at molecular levels; second, it enables early detection of fibrotic changes before structural damage occurs; third, when combined with other imaging modalities, it permits comprehensive assessment of disease progression. These capabilities make FAPI imaging a powerful tool for identifying candidates for anti-fibrotic therapy and monitoring treatment efficacy.
Integrated PET/MR technology represents another major breakthrough in cardiac imaging. By combining the superior soft-tissue resolution of MR with PET's molecular sensitivity, simultaneous PET/CMR systems provide unparalleled insights into cardiac structure and function[6]. This hybrid approach integrates anatomical details from CMR (including late gadolinium enhancement patterns) with metabolic information from PET, delivering more comprehensive data than either modality alone. Importantly, PET/CMR achieves this without additional radiation exposure from CT components, making it particularly suitable for longitudinal studies. While clinical applications in CVDs remain investigational, PET/CMR holds tremendous promise for advancing our understanding of disease mechanisms and enabling personalized treatment strategies.
This research project aims to harness these technological advancements for improved CVD management. By implementing 68Ga-FAPI PET/CMR multi-modal imaging, we seek to achieve precise quantification of myocardial fibrosis and comprehensive evaluation of cardiac function in a single examination. The synergistic combination of 68Ga-FAPI's molecular targeting capability with CMR's structural and functional assessment offers several clinical benefits: it streamlines diagnostic workflows, enhances accuracy, facilitates timely intervention, and ultimately may improve patient outcomes. Through this innovative approach, we hope to establish a new paradigm in CVD care that combines cutting-edge imaging technology with personalized medicine principles, thereby addressing the growing burden of cardiovascular diseases more effectively.
- Conditions
- Cardiovascular Diseases (CVD)
- Keywords
- Cardiovascular diseases, FAPI, PET/MR
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Research group | Thirty patients with cardiovascular diseases were enrolled as the research group. | |
| Healthy controls | Ten healthy individuals were enrolled as the healthy controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CE-CMR
Left ventricular wall thickness was quantified on short-axis cine images using the MR cardiac analysis software .
Measured: After the patient completes the scan, an average of 2 days.
CE-MRI
Left ventricular ejection fraction (LVEF) was calculated from short-axis cine images using the cardiac MR analysis software.
Measured: After the patient completes the scan, an average of 2 days.
PET
The maximum standardized uptake value (SUVmax) was calculated for each myocardial segment.
Measured: After the patient completes the scan, an average of 2 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Dec 2024
- Primary completion31 Dec 2028 (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 Cardiovascular Diseases (CVD)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063043
- Sponsor's protocol ID
- 2025YS-039
- Status last verified
- Dec 2024
- First submitted
- 3 Jul 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For the protection of patient privacy, we will not share patient information, but other researchers can apply through the project contact person if they have reasonable reasons.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research on 68Ga-FAPI PET/CMR in Cardiovascular Diseases
- ClinicalTrials.gov ID
- NCT07063043
- Acronym / sponsor ID
- 2025YS-039
- Conditions
- Cardiovascular Diseases (CVD)
- Keywords
- Cardiovascular diseases, FAPI, PET/MR
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 Jul 2025 (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.
FAP-targeted PET imaging using 68Ga-FAPI enables early detection of myocardial fibrosis. Combined PET/CMR provides comprehensive cardiac assessment without extra radiation. This advanced imaging approach improves diagnosis and personalized treatment for better patient outcomes.
Detailed description
Cardiovascular diseases (CVDs) are among the leading causes of death and disability worldwide. According to statistics from the World Health Organization (WHO), over 17 million people die from CVDs each year, accounting for 31% of global mortality[1]. In China, the incidence and mortality rates of CVDs continue to rise alarmingly. The China Cardiovascular Health and Diseases Report indicates that approximately 300 million Chinese suffer from CVDs, with annual CVD-related deaths exceeding 4 million - representing over 40% of the country's total deaths[2]. These concerning trends highlight CVDs as a major public health crisis demanding urgent attention.
Recent advances in molecular imaging have opened new avenues for CVD diagnosis and management. Fibroblast activation protein (FAP), a type II transmembrane serine protease, shows minimal expression in normal tissues but becomes markedly upregulated in various pathological conditions including malignant tumors, inflammatory diseases, and fibrotic processes[3,4]. Of particular significance is its role in myocardial fibrosis - a key pathological mechanism underlying many CVDs[5]. Current diagnostic methods for myocardial fibrosis remain limited, with histopathology being invasive and conventional imaging techniques like echocardiography and cardiac MR (CMR) only detecting late-stage changes. The emergence of radiolabeled FAP inhibitors (FAPIs) has enabled non-invasive visualization of early myocardial fibrosis, offering unprecedented opportunities for dynamic monitoring of disease progression and treatment response.
The clinical potential of FAPI-based imaging in CVDs is increasingly recognized. Although still in the exploratory phase, studies have consistently demonstrated FAPI uptake in various CVD animal models and human patients, confirming the activation of cardiac fibroblasts and FAP expression across different disease states. This technology provides three key advantages: first, it allows in vivo visualization of fibroblast activity at molecular levels; second, it enables early detection of fibrotic changes before structural damage occurs; third, when combined with other imaging modalities, it permits comprehensive assessment of disease progression. These capabilities make FAPI imaging a powerful tool for identifying candidates for anti-fibrotic therapy and monitoring treatment efficacy.
Integrated PET/MR technology represents another major breakthrough in cardiac imaging. By combining the superior soft-tissue resolution of MR with PET's molecular sensitivity, simultaneous PET/CMR systems provide unparalleled insights into cardiac structure and function[6]. This hybrid approach integrates anatomical details from CMR (including late gadolinium enhancement patterns) with metabolic information from PET, delivering more comprehensive data than either modality alone. Importantly, PET/CMR achieves this without additional radiation exposure from CT components, making it particularly suitable for longitudinal studies. While clinical applications in CVDs remain investigational, PET/CMR holds tremendous promise for advancing our understanding of disease mechanisms and enabling personalized treatment strategies.
This research project aims to harness these technological advancements for improved CVD management. By implementing 68Ga-FAPI PET/CMR multi-modal imaging, we seek to achieve precise quantification of myocardial fibrosis and comprehensive evaluation of cardiac function in a single examination. The synergistic combination of 68Ga-FAPI's molecular targeting capability with CMR's structural and functional assessment offers several clinical benefits: it streamlines diagnostic workflows, enhances accuracy, facilitates timely intervention, and ultimately may improve patient outcomes. Through this innovative approach, we hope to establish a new paradigm in CVD care that combines cutting-edge imaging technology with personalized medicine principles, thereby addressing the growing burden of cardiovascular diseases more effectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Research group | – | –Thirty patients with cardiovascular diseases were enrolled as the research group. |
| Healthy controls | – | –Ten healthy individuals were enrolled as the healthy controls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cardiovascular diseases
Key inclusion criteria (4 listed)
- Participants must have a confirmed clinical diagnosis of cardiovascular disease by a cardiologist, based on genetic testing, family history, and comprehensive clinical evaluation including physical examination, echocardiography, and when indicated, cardiac MRI findings.
- Age requirement: >18 years.
- Patients should demonstrate stable cardiovascular status without significant changes in symptoms, treatment, or clinical findings for a specified pre-enrollment period.
- Participants must be capable of providing informed consent and willing to adhere to all study requirements, including follow-up procedures.
Key exclusion criteria (7 listed)
- History of malignancy
- Documented cardiovascular diseases, including coronary artery disease, myocardial infarction, or related conditions
- Implanted metallic devices (e.g., pacemakers, aneurysm clips) or other MRI-incompatible medical prostheses
- Claustrophobia
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CE-CMR
Time frame: After the patient completes the scan, an average of 2 days.
Left ventricular wall thickness was quantified on short-axis cine images using the MR cardiac analysis software .
CE-MRI
Time frame: After the patient completes the scan, an average of 2 days.
Left ventricular ejection fraction (LVEF) was calculated from short-axis cine images using the cardiac MR analysis software.
PET
Time frame: After the patient completes the scan, an average of 2 days.
The maximum standardized uptake value (SUVmax) was calculated for each myocardial segment.
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 14 Jul 2025.
- Individual participant dataSharing planned: No. For the protection of patient privacy, we will not share patient information, but other researchers can apply through the project contact person if they have reasonable reasons.
Related trials for Cardiovascular Diseases (CVD)
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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?
An observational study of Cardiovascular Diseases (CVD), run by Shanghai East 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 4 inclusion and 7 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 14 Jul 2025. 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.
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 Jie Ding, MD (086-38804518, dingjie940406@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CE-CMR (time frame: After the patient completes the scan, an average of 2 days.). 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 14 Jul 2025.