Myocardial FibrosisNCT05867589
Study of Novel PET Tracer Gallium [68Ga]/ Fluorine [18F] -FAPI-04 in the Diagnosis of Cardiovascular Diseases
A study testing 68Ga/18F-FAPI-04 in people with Myocardial Fibrosis, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety of fibroblast activating protein receptor imaging agent [68Ga]/ Fluorine [18F] -fibroblast activating protein inhibitor (68Ga/18F-FAPI-04) in clinical application and to verify its effectiveness in the diagnosis of cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Myocardial Fibrosis
- What is being tested?
- 68Ga/18F-FAPI-04
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary subjects, patients or their legal representatives to sign informed consent;
- There was no limitation on the gender of the volunteers, whose age ranged from 18 to 85 years old, including the cut-off value;
- Myocardial injury caused by various causes was found by other imaging methods (cardiac ultrasound, coronary angiography, coronary CT, cardiac MRI, etc.);
- Kidney GFR > 50 ml/min, ERPF > 280 ml/min, platelet count (PLT) > 75 000/μL, leukocyte (WBC) > 3000/μL, alanine aminotransferase ALT, aspartate aminotransferase AST < 3 times the normal value.
Who cannot join
- Allergic to the same drugs (drugs with similar chemical or biological components to fibroblast activating protein inhibitors), allergic constitution or currently suffering from allergic diseases;
- Clinical investigators who are currently conducting clinical studies on other drugs, or who have participated in any drug (excluding vitamins and minerals);
- Have other clinical problems that are difficult to control (such as HIV, hepatitis C virus infection or active hepatitis B, or other severe chronic infections and serious mental, neurological, respiratory and other diseases);
- Red blood cell RBC is less than 4×1012, white blood cell WBC is less than 3×109, hemoglobin is less than 80g/L, PLT is less than 75,000 ×109;
- Significantly abnormal liver and kidney function, GFR less than 20 ml/min;
- Cardiac ejection fraction (EF) was assessed to be less than 10%;
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- The expected survival time is less than half a year; Coronary stent implantation within 2 weeks or coronary artery bypass graft within 6 months;
- Severe acute concomitant disease or severe refractory mental disorder;
- Pregnant and lactating women (pregnancy is defined as positive in blood pregnancy studies);
- Patients whose physical conditions are not suitable for radioactive examination;
- Patients with metal implants (pacemakers, etc.) or spatial claustrophobia or other MRI related contraindications;
- Any situation that the presiding officer of this study believes may cause harm or potential harm to any link related to this test.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Feng Wang, +8602552271491, fengwangcn@hotmail.com
Rui Luo, +8602552271455, luorui0916@126.com
About this study
The purpose of this study is to evaluate the safety of fibroblast activating protein receptor imaging agent [68Ga]/ Fluorine [18F] -fibroblast activating protein inhibitor (68Ga/18F-FAPI-04) in clinical application and to verify its effectiveness in the diagnosis of cardiovascular diseases.
Read the detailed description
The implementation of this project will promote the research of PET-MRI molecular imaging using the new nuclide imaging with the target of FAP combined with the MRI T1 mapping and ECV measurement technology, realize the fusion of nuclear medicine and magnetic resonance technology in a real sense, dynamically monitor the occurrence and development of myocardial fibrosis in heart failure at an early stage, and establish a complete set of myocardial fibrosis imaging programs. To provide an important basis for the exploration of anti-fibrosis therapy in heart failure and accelerate the pace of clinical transformation of this protocol.
- Conditions
- Myocardial Fibrosis
- Being tested
- 68Ga/18F-FAPI-04
- Keywords
- Fibroblast Activation Protein, PET-MRI,myocardial fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga/18F-FAPI-04Drug
Subjects will receive one injection of 68Ga/18F-FAPI-04 (0.1~0.15mCi/Kg), a PET radiopharmaceutical selective for fibroblast activation protein. 68Ga/18F-FAPI-04 injection will be followed by a 10 ml saline flush.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga/18F-FAPI-04 | Experimental | For the injection, subjects will receive a target dose of 0.1~0.15mCi/Kg 68Ga/18F-FAPI-04 as a bolus injection. Receives: Drug: 68Ga/18F-FAPI-04 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of 68Ga/18F-FAPI-04 Uptake Patterns by Regional SUV Values
68Ga/18F-FAPI-04 uptake patterns will be assessed in regions of interest (ROIs) which relevant to myocardial fibrosis pathology. Standard uptake value (SUV) will be calculated for each ROI, and standardized uptake value ratios (SUVRs) will be calculated by normalizing SUV of ROIs to the SUV of relevant reference region.
Measured: 31 months
Safety and Tolerability Profile Measured by Adverse Events (AEs)
Safety and tolerability profile for the administration of 68Ga/18F-FAPI-04 and positron emission tomography (PET) scanning are measured by number of participants with adverse events (AEs).
Measured: 31 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 May 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial FibrosisStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FengWang, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Feng Wang, Study director, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867589
- Sponsor's protocol ID
- KY20230428-02
- Status last verified
- May 2023
- First submitted
- 11 May 2023
- Last updated
- 22 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Luo R, Zhao Z, Zhang C, Li RS, Wang Y, Meng Q, Ni Y, Wang B, Li L, Feng L, Yang R, Xie L, Chen X, Zhang MR, Wang F. Evaluation of myocardial fibrosis and wall motion abnormality with 68Ga-FAPI PET/MR in coronary heart disease. EJNMMI Res. 2025 Jul 21;15(1):89. doi: 10.1186/s13550-025-01246-2.
PubMed 40690085
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Novel PET Tracer Gallium [68Ga]/ Fluorine [18F] -FAPI-04 in the Diagnosis of Cardiovascular Diseases
- ClinicalTrials.gov ID
- NCT05867589
- Acronym / sponsor ID
- KY20230428-02
- Conditions
- Myocardial Fibrosis
- Keywords
- Fibroblast Activation Protein, PET-MRI,myocardial fibrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 May 2023 (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.
The purpose of this study is to evaluate the safety of fibroblast activating protein receptor imaging agent [68Ga]/ Fluorine [18F] -fibroblast activating protein inhibitor (68Ga/18F-FAPI-04) in clinical application and to verify its effectiveness in the diagnosis of cardiovascular diseases.
Detailed description
The implementation of this project will promote the research of PET-MRI molecular imaging using the new nuclide imaging with the target of FAP combined with the MRI T1 mapping and ECV measurement technology, realize the fusion of nuclear medicine and magnetic resonance technology in a real sense, dynamically monitor the occurrence and development of myocardial fibrosis in heart failure at an early stage, and establish a complete set of myocardial fibrosis imaging programs. To provide an important basis for the exploration of anti-fibrosis therapy in heart failure and accelerate the pace of clinical transformation of this protocol.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga/18F-FAPI-04 | Experimental | Drug: 68Ga/18F-FAPI-04For the injection, subjects will receive a target dose of 0.1~0.15mCi/Kg 68Ga/18F-FAPI-04 as a bolus injection. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntary subjects, patients or their legal representatives to sign informed consent;
- There was no limitation on the gender of the volunteers, whose age ranged from 18 to 85 years old, including the cut-off value;
- Myocardial injury caused by various causes was found by other imaging methods (cardiac ultrasound, coronary angiography, coronary CT, cardiac MRI, etc.);
- Kidney GFR > 50 ml/min, ERPF > 280 ml/min, platelet count (PLT) > 75 000/μL, leukocyte (WBC) > 3000/μL, alanine aminotransferase ALT, aspartate aminotransferase AST < 3 times the normal value.
Key exclusion criteria (12 listed)
- Allergic to the same drugs (drugs with similar chemical or biological components to fibroblast activating protein inhibitors), allergic constitution or currently suffering from allergic diseases;
- Clinical investigators who are currently conducting clinical studies on other drugs, or who have participated in any drug (excluding vitamins and minerals);
- Have other clinical problems that are difficult to control (such as HIV, hepatitis C virus infection or active hepatitis B, or other severe chronic infections and serious mental, neurological, respiratory and other diseases);
- Red blood cell RBC is less than 4×1012, white blood cell WBC is less than 3×109, hemoglobin is less than 80g/L, PLT is less than 75,000 ×109;
- Significantly abnormal liver and kidney function, GFR less than 20 ml/min;
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 |
|---|---|---|
| 68Ga/18F-FAPI-04Subjects will receive one injection of 68Ga/18F-FAPI-04 (0.1~0.15mCi/Kg), a PET radiopharmaceutical selective for fibroblast activation protein. 68Ga/18F-FAPI-04 injection will be followed by a 10 ml saline flush. | Drug | 68Ga/18F-FAPI-04 |
Primary outcome
Assessment of 68Ga/18F-FAPI-04 Uptake Patterns by Regional SUV Values
Time frame: 31 months
68Ga/18F-FAPI-04 uptake patterns will be assessed in regions of interest (ROIs) which relevant to myocardial fibrosis pathology. Standard uptake value (SUV) will be calculated for each ROI, and standardized uptake value ratios (SUVRs) will be calculated by normalizing SUV of ROIs to the SUV of relevant reference region.
Safety and Tolerability Profile Measured by Adverse Events (AEs)
Time frame: 31 months
Safety and tolerability profile for the administration of 68Ga/18F-FAPI-04 and positron emission tomography (PET) scanning are measured by number of participants with adverse events (AEs).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Derived from this study: PubMed 40690085Luo R, Zhao Z, Zhang C, Li RS, Wang Y, Meng Q, Ni Y, Wang B, Li L, Feng L, Yang R, Xie L, Chen X, Zhang MR, Wang F. Evaluation of myocardial fibrosis and wall motion abnormality with 68Ga-FAPI PET/MR in coronary heart disease. EJNMMI Res. 2025 Jul 21;15(1):89. doi: 10.1186/s13550-025-01246-2.
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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. This study is not recruiting at the moment.
Feng Wang study director
Nanjing First Hospital, Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga/18F-FAPI-04 in people with Myocardial Fibrosis, run by Nanjing First Hospital, Nanjing Medical University 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 12 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: status not confirmed, as of the sponsor's last update on 22 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng Wang (02552271491, fengwangcn@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of 68Ga/18F-FAPI-04 Uptake Patterns by Regional SUV Values (time frame: 31 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05867589, which also lists 1 linked publication.
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 22 May 2023.