Clinical Study of [18F]FT8 PET/CT in Evaluating Amyloidosis

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

\[18F\]FT8, a derivative of 1-(4-pyridyl)-4-piperazinyl arene (\[18F\]TPZA), exhibits high affinity for AL amyloid in myocardial tissue sections and shows no significant binding to transthyretin amyloid. By comparing its diagnostic performance against established clinical methods, including echocardiography, contrast-enhanced MRI, and relevant laboratory tests, this study aims to establish \[18F\]FT8 as the basis for a robust PET protocol for the direct visualization and differential diagnosis of AL amyloidosis . The study preimarily evaluates the safety and diagnostic efficacy of \[18F\]FT8 PET imaging in human subjects.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ Subjects must meet all of the following criteria:

• Adult subjects (age ≥ 18 years);

• No clinical evidence of active cardiac or systemic disease, as confirmed by medical history review, physical examination, and electrocardiogram (ECG).

Locations
Other Locations
China
The First Affiliated Hospital of University of Science and Technology of China
RECRUITING
Hefei
Tianjin Medical University General Hospital
RECRUITING
Tianjin
Contact Information
Primary
Haonan Yu
dreamadam@126.com
+8613821000597
Time Frame
Start Date: 2025-07-21
Estimated Completion Date: 2028-12-20
Participants
Target number of participants: 25
Treatments
Healthy participants
Participants will receive a single intravenous bolus injection of 10 ± 3 mCi of \[18F\]FT8 followed by a PET/CT scan.
Amyloidosis Patients
Participants will receive a single intravenous bolus injection of 10 ± 3 mCi of \[18F\]FT8, followed by a PET/CT scan.
Sponsors
Leads: Tianjin Medical University
Collaborators: Tianjin Medical University General Hospital

This content was sourced from clinicaltrials.gov