Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2025-12-24 @ 12:44 PM
NCT ID:
NCT06562361
Brief 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.
Detailed Description:
This is a first-in-human (FIH), phase 0, multi-center, non-randomized trial to investigate \[68Ga\]Ga-DOTA-Cys-ATH001 PET-tracer binding in the liver and in the GI tract in healthy subjects and patients with metabolically caused steatohepatitis (MASH), patients with fibrostenotic Crohn´s Disease (CD) and patients with primary sclerosing cholangitis (PSC), in a total of 5 different cohorts, including a sub-trial to assess test-retest reliability and a sub-trial to assess dosimetry. The allocation of cohorts is:
* Cohort 1a (n=3): Healthy volunteers, sub-group dosimetry,
* Cohort 1b (n=3): Healthy volunteers, sub-group test/retest,
* Cohort 2a (n=3): Presumed MASH patients, sub-group dosimetry,
* Cohort 2b (n=3): Presumed MASH patients, sub-group test/retest,
* Cohort 3 (n=6): Verified MASH patients,
* Cohort 4 (n=6): Fibrostenotic CD patients,
* Cohort 5 (n=6): PSC patients.
The participants will come for 2 or 3 visits to the trial site. The screening (Visit 1) will include an eligibility check and review of health status. Participants in cohort 2 and cohort 3 will perform a FibroScan® investigation.
At Visit 2, participants will come to the trial site for PET/MRI and safety assessments. The participants will receive a single, bolus iv injection of a maximum of 100 µg \[68Ga\]Ga-DOTA-Cys-ATH001 after which participants will be examined by whole-body PET/MRI scans. A sub-group of participants in cohort 1 (cohort 1a, healthy subjects, n=3, the first 3 participants in this cohort) and cohort 2 (cohort 2a, presumed MASH patients, n=3, the first 3 participants in this cohort) will be participating in a sub-trial to calculate the whole-body dosimetry of the tracer. These participants will have one longer PET visit and will be examined by sequential whole-body PET/MRI scans to determine tracer biodistribution and clearance. At Visit 4 (within 6 weeks of Visit 2), participants taking part in the test/retest sub-trial (Cohorts 1b and 2b) will come for a second PET/MRI visit which includes a second administration of \[68Ga\]Ga-DOTA-Cys-ATH001.
To determine tracer clearance from blood, venous (1a and b and 2a and b) and arterial (1b and 2b) PK samples will be collected post-dose. No PK samples will be taken from cohorts 3 to 5.
Safety assessments will take place after the PET/MRI (vital signs, 12-lead ECG, safety laboratory sampling and injection site reactions). A remote follow-up by telephone (Visit 3) will be performed the day after \[68Ga\]Ga-DOTA-Cys-ATH001 dosing to follow-up on AEs, injection site reactions and concomitant medication.For participants in cohorts 1b and 2b (the test/retest sub-group), a remote follow-up by telephone (Visit 5) will be performed the day after \[68Ga\]Ga-DOTA-Cys-ATH001 dosing to follow-up on AEs, injection site reactions and concomitant medication.
Study:
NCT06562361
Study Brief:
Protocol Section:
NCT06562361