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

NCT05867589 | Unknown

• 1 other identifier: KY20230428-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Fibrosis

Keywords

Fibroblast Activation Protein, PET-MRI,myocardial fibrosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

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.

Drug: 68Ga/18F-FAPI-04

Interventions

68Ga/18F-FAPI-04 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.

68Ga/18F-FAPI-04

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%;
• 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40690085 DERIVED

Study Officials

• Feng Wang

  Nanjing First Hospital, Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Feng Wang

CONTACT

02552271491; fengwangcn@hotmail.com

Rui Luo

CONTACT

02552271491; luorui0916@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of nuclear medicine department

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 22, 2023
• Study Start: May 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 22, 2023

Record last verified: 2023-05

Locations

CN (1)