Study of Novel PET Tracer Gallium [68Ga]/ Fluorine [18F] -FAPI-04 in the Diagnosis of Cardiovascular Diseases

Myocardial Fibrosis Clinical Trial

Official title:

Study of Novel PET Tracer Gallium [68Ga]/ Fluorine [18F] -FAPI-04 in the Diagnosis of Cardiovascular Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05867589
• Other study ID #: KY20230428-02
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Feng Wang
• Phone: 02552271491
• Email: fengwangcn[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Voluntary subjects, patients or their legal representatives to sign informed consent;

2. There was no limitation on the gender of the volunteers, whose age ranged from 18 to 85 years old, including the cut-off value;

3. Myocardial injury caused by various causes was found by other imaging methods (cardiac ultrasound, coronary angiography, coronary CT, cardiac MRI, etc.);

4. 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.

Exclusion Criteria:

1. 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;

2. Clinical investigators who are currently conducting clinical studies on other drugs, or who have participated in any drug (excluding vitamins and minerals);

3. 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);

4. 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;

5. Significantly abnormal liver and kidney function, GFR less than 20 ml/min;

6. Cardiac ejection fraction (EF) was assessed to be less than 10%;

7. The expected survival time is less than half a year; Coronary stent implantation within 2 weeks or coronary artery bypass graft within 6 months;

8. Severe acute concomitant disease or severe refractory mental disorder;

9. Pregnant and lactating women (pregnancy is defined as positive in blood pregnancy studies);

10. Patients whose physical conditions are not suitable for radioactive examination;

11. Patients with metal implants (pacemakers, etc.) or spatial claustrophobia or other MRI related contraindications;

12. Any situation that the presiding officer of this study believes may cause harm or potential harm to any link related to this test.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Fibrosis
• Myocardial Fibrosis

Intervention

Drug:
• 68Ga/18F-FAPI-04
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.

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	31 months
Primary	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).	31 months