Visualized Monitoring of Fibrosis Formation in Heart Failure With 68GA-FAPI PET

NCT04982458 | Unknown

• 1 other identifier: XLan-0617-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Positron Emission Tomography

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of 68Ga-FAPI PET for diagnosis and staging in heart failure.

  For 50 subjects with suspected or diagnosed or treated heart failure who have completed 13N-NH3 imaging, diagnosis and staging results of 68Ga-FAPI PET will be compared to pathology, clinical and follow-up result.

  2 years

Interventions

68Ga-FAPI DIAGNOSTIC_TEST

68Ga-FAPI injection is a radiopharmaceutical used for positron emission tomography (PET) diagnosis. This product is used for PET, qualitative and localized diagnosis and evaluation of abnormal expression of fibroblast-activated protein in focus-associated fibroblasts.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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;

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Xiaoli Lan

Wuhan, Hubei, 430022, China

Location

Related Publications (1)

• 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.

  PMID: 36269382 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Xiaoli Lan, PhD

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of nuclear medicine

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: July 29, 2021
• Study Start: August 1, 2021
• Primary Completion: August 31, 2022
• Study Completion: December 31, 2023
• Last Updated: October 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)