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

NCT ID: NCT05867589

Last Updated: 2023-05-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-12-31

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

68Ga/18F-FAPI-04

For the injection, subjects will receive a target dose of 0.1\~0.15mCi/Kg 68Ga/18F-FAPI-04 as a bolus injection.

Group Type: EXPERIMENTAL

68Ga/18F-FAPI-04

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

FengWang

Director of nuclear medicine department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Feng Wang

Role: STUDY_DIRECTOR

Nanjing First Hospital, Nanjing Medical University

Locations

Nanjing First Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Feng Wang

Role: CONTACT

fengwangcn@hotmail.com

02552271491

Rui Luo

Role: CONTACT

luorui0916@126.com

02552271491

Facility Contacts

Feng Wang

Role: primary

fengwangcn@hotmail.com

+8602552271491

Rui Luo

Role: backup

luorui0916@126.com

+8602552271455

References

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.

Reference Type: DERIVED

PMID: 40690085 (View on PubMed)

Other Identifiers

KY20230428-02

Identifier Type: -

Identifier Source: org_study_id