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Study identifier: NCT06562361 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

A Microdose Trial Investigating Binding of [68Ga]Ga-DOTA-CYS-ATH001 in Healthy Subjects and Different Patient Groups.

Condition: MASH · PSC · Fibrostenotic Crohn's Disease  ·  Sponsor: Antaros Medical

PhaseEARLY_Phase 1
Planned participants30
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersYes

About this study

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 examina…

This description comes directly from the study's public registry record.

Talk to the study team

Johan Vessby, MD, PhD  ·  +46 (0)73 356 93 04  ·  johan.vessby@akademiska.se

Always discuss trial participation with your own doctor first.

Locations (3)

CTC KarolinskaStockholm, SwedenRecruiting
CTC Akademiska Uppsala University Hospital, Entrance 85, 2nd levelUppsala, SwedenNot Yet Recruiting
Section of Gastroenterology/Hepatology, Uppsala University HospitalUppsala, SwedenNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT06562361