RecruitingEarly Phase 1NCT06562361

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

A First-In-Human, Microdosing, Clinical Trial to Investigate Binding of the PET Tracer [68Ga]Ga-DOTA-CYS-ATH001 Targeting PDGFRβ in Healthy Subjects as Compared to Patients With MASH, PSC and CD


Sponsor

Antaros Medical

Enrollment

30 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This imaging study gives healthy volunteers and patients with liver diseases (fatty liver disease called MASH, Crohn's disease, or primary sclerosing cholangitis) a tiny "microdose" of a new PET imaging agent to see how it distributes in the body, in order to develop better tools for detecting liver scarring (fibrosis). **You may be eligible if...** - You are aged 18–75 with a BMI between 19 and 40 - You are either: a healthy volunteer, a patient with presumed or confirmed MASH (fatty liver disease with scarring), a patient with fibrostenotic Crohn's disease, or a patient with primary sclerosing cholangitis (a bile duct disease) - You have specific lab and imaging findings consistent with your patient group **You may NOT be eligible if...** - You cannot have an MRI scan (e.g., due to metal implants, claustrophobia) - You have active HIV, hepatitis B, or hepatitis C - You are pregnant or breastfeeding - You have had a recent major illness, surgery, or significant cancer within the past year - You have severe liver disease with decompensation (fluid in abdomen, confusion from liver failure) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG[68Ga]Ga-DOTA-Cys-ATH001

Target dose of 200MBq \[68Ga\]Ga-DOTA-Cys-ATH001 corresponding to a maximum mass dose of 100 µg, administered as an intravenous bolus dose.


Locations(3)

CTC Karolinska

Stockholm, Sweden

CTC Akademiska Uppsala University Hospital, Entrance 85, 2nd level

Uppsala, Sweden

Section of Gastroenterology/Hepatology, Uppsala University Hospital

Uppsala, Sweden

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NCT06562361


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