Clinical trial NCT05867589: Study of Novel PET Tracer Gallium [68Ga]/ Fluorine [18F] -FAPI-04 in the Diagnosis of Cardiovascular Diseases
Official title: Study of Novel PET Tracer Gallium [68Ga]/ Fluorine [18F] -FAPI-04 in the Diagnosis of Cardiovascular Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myocardial Fibrosis
Keywords: Fibroblast Activation Protein, PET-MRI,myocardial fibrosis
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Assessment of 68Ga/18F-FAPI-04 Uptake Patterns by Regional SUV Values
timeFrame: 31 months
measure: Safety and Tolerability Profile Measured by Adverse Events (AEs)
timeFrame: 31 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Feng Wang
role: STUDY_DIRECTOR
References: