Clinical trial NCT04982458: Visualized Monitoring of Fibrosis Formation in Heart Failure With 68GA-FAPI PET
Official title: Clinical Study of 68 GA-FAPI PET Imaging Noninvasive Visible Fibrosis Formation in Heart Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Positron Emission Tomography
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with clinically suspected or confirmed heart failure (supporting evidence including visual examination, cardiac MRI, cardiac ultrasound, and serological indicators, etc.), and who have consenting to 68GA-FAPI and 13N-NH3 imaging;

Brief summary: This is a diagnostic study. Patients were included from patients with clinically suspected or confirmed heart failure, and 68Ga-FAPI and 13N-NH3 gated myocardial imaging were performed to evaluate the effectiveness of 68Ga-FAPI PET imaging in visualizing the degree of myocardial fibrosis in patients with heart failure. The subjects completed 68Ga-FAPI and 13N-NH3 gated myocardial imaging in a one-stop process, and collected general information, clinical data, echocardiography, blood routine, liver and kidney function indicators, 68Ga-FAPI and 13N-NH3 PET imaging results and other imaging data of the patients and volunteers.

Detailed description: Fibroblast activated protein (FAP) is a type II membrane-bound glycoprotein that is highly specifically expressed in activated fibroblast reactions. The 68Ga labeled fibroblast activated protein inhibitor (68 ga-fapi) has shown advantages of high uptake and high image contrast in imaging the activated fibroblast response, including its successful use in visualizing the degree of liver fibrosis. The molecular imaging probe targeting FAP combined with the mature myocardial perfusion imaging agent 13N-NH3 can help us to achieve the following objectives: On the one hand, to investigate the myocardial fibrosis in patients with heart failure and to visualize the formation of fiBER-activated protein in the process of heart failure; At the same time, the performance of 68GA-FAPI in differential diagnosis of heart failure and grading of heart failure degree was discussed, so as to make up for the insufficiency of clinical routine imaging technology in the diagnosis of myocardial fibrosis in heart failure.

Eligibility criteria: Inclusion Criteria:

* Adult patients (age 18 years or above), gender is not limited;
* Patients with clinically suspected or confirmed heart failure (supporting evidence includes visual examination, cardiac MRI, cardiac ultrasound, and serological indicators, etc.), and patients who agree to undergo 68Ga-FAPI and 13N-NH3 imaging;
* The patient or his legal representative can sign the informed consent.

Exclusion Criteria:

* Acute systemic diseases and electrolyte disorders；
* Pregnant or lactating women；
* Patients refuse to sign the informed consent.

Primary outcomes:
measure: Sensitivity and specificity of 68Ga-FAPI PET for diagnosis and staging in heart failure.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Xiaoli Lan
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: Xiaoli Lan, PhD
role: STUDY_CHAIR
References:
citation: Song W, Zhang X, He S, Gai Y, Qin C, Hu F, Wang Y, Wang Z, Bai P, Wang J, Lan X. 68Ga-FAPI PET visualize heart failure: from mechanism to clinic. Eur J Nucl Med Mol Imaging. 2023 Jan;50(2):475-485. doi: 10.1007/s00259-022-05994-4. Epub 2022 Oct 21.