A Microdose Trial Investigating Binding of [68Ga]Ga-DOTA-CYS-ATH001 in Healthy Subjects and Different Patient Groups.
Status:
RECRUITING
Trial end date:
2026-03-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to use positron emission tomography (PET) to evaluate and compare the binding of the novel tracer \[68Ga\]Ga-DOTA-Cys-ATH001 in the liver and/or gastrointestinal tract between healthy volunteers and different patient groups including patients with metabolically caused steatohepatitis (MASH), patients with fibrostenotic Crohn´s Disease (CD) and patients with primary sclerosing cholangitis (PSC).The study will also assess the safety of a microdose of 68Ga\]Ga-DOTA-Cys-ATH001 and how it is distributed in different parts of the body. The main questions the study aims to answer are:
* What does the uptake of the \[68Ga\]Ga-DOTA-Cys-ATH001 PET-tracer look like in the liver of healthy subjects, and in that of patients with MASH and PSC?
* What does the uptake of the \[68Ga\]Ga-DOTA-Cys-ATH001 PET-tracer look like in the GI tract of healthy subjects, and that of patients with fibrostenotic CD?
* How much \[68Ga\]Ga-DOTA-Cys-ATH001 PET-tracer can be found in the blood after injection?
* How is \[68Ga\]Ga-DOTA-Cys-ATH001 uptake distributed in the body?
* What medical problems do participants have when receiving \[68Ga\]Ga-DOTA-Cys-ATH001?
Participants will:
Receive one administration of \[68Ga\]Ga-DOTA-Cys-ATH001, after which examination with PET is performed. Magnetic Resonance Imaging (MRI) is also used in the study to create a detailed picture of the body and its function which will facilitate the interpretation of the results of the PET examination. A subset of participants will have blood samples collected after the tracer administration to assess the blood levels of the tracer over time.
A subset of participants will come back for a second visit where they will receive a second administration of \[68Ga\]Ga-DOTA-Cys-ATH001, followed by PET and MRI.
A health check-up is performed before dosing, and a safety assessment will be performed after dosing. A remote follow-up visit is performed the day after the dosing visit.