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

Primary Purpose

Myocardial Fibrosis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
68Ga/18F-FAPI-04
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocardial Fibrosis focused on measuring Fibroblast Activation Protein, PET-MRI,myocardial fibrosis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Nanjing First HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga/18F-FAPI-04

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

Full Information

First Posted
May 11, 2023
Last Updated
May 11, 2023
Sponsor
Nanjing First Hospital, Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05867589
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Fibrosis
Keywords
Fibroblast Activation Protein, PET-MRI,myocardial fibrosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Ga/18F-FAPI-04
Arm Type
Experimental
Arm Description
For the injection, subjects will receive a target dose of 0.1~0.15mCi/Kg 68Ga/18F-FAPI-04 as a bolus injection.
Intervention Type
Drug
Intervention Name(s)
68Ga/18F-FAPI-04
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of 68Ga/18F-FAPI-04 Uptake Patterns by Regional SUV Values
Description
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.
Time Frame
31 months
Title
Safety and Tolerability Profile Measured by Adverse Events (AEs)
Description
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).
Time Frame
31 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng Wang
Phone
02552271491
Email
fengwangcn@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rui Luo
Phone
02552271491
Email
luorui0916@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng Wang
Organizational Affiliation
Nanjing First Hospital, Nanjing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Wang
Phone
+8602552271491
Email
fengwangcn@hotmail.com
First Name & Middle Initial & Last Name & Degree
Rui Luo
Phone
+8602552271455
Email
luorui0916@126.com

12. IPD Sharing Statement

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

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