Actively Recruiting
A Microdose Trial Investigating Binding of [68Ga]Ga-DOTA-CYS-ATH001 in Healthy Subjects and Different Patient Groups.
Led by Antaros Medical · Updated on 2024-08-29
30
Participants Needed
3
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Microdose Trial Investigating Binding of [68Ga]Ga-DOTA-CYS-ATH001 in Healthy Subjects and Different Patient Groups.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent and comply with trial procedures
- Male or female aged 18 to 75 years at screening
- Body mass index (BMI) between 19 and less than 40 kg/m2 at screening
- Women of childbearing potential must use effective contraception or abstinence before and after tracer administration as specified
- Male participants must use condoms, be vasectomized, or abstain from heterosexual intercourse to prevent pregnancy and refrain from sperm donation during the study
- Cohort 1: Healthy participants with no significant medical history or abnormal findings at screening
- Cohort 2: Presumed MASH patients with steatosis confirmed by biopsy, imaging, or controlled attenuation parameter (CAP) and at least one cardiometabolic risk factor
- Cohort 3: Verified MASH patients with historical biopsy-proven disease, steatosis, and cardiometabolic criteria
- Cohort 4: Patients with fibrostenotic Crohn's Disease with MRI or colonoscopy evidence, Crohn's Disease Activity Index (CDAI) <150, calprotectin <250, and C-reactive protein (CRP) <20
- Cohort 5: Patients with large duct primary sclerosing cholangitis (PSC) confirmed by MRI/MRCP with ProC3 ≥12.6 ng/mL
You will not qualify if you...
- Contraindications for MRI including claustrophobia, metal implants, inability to stay supine for 90 minutes, or permanent makeup/tattoos interfering with imaging
- History of working as a metal worker or welder
- Clinically significant disease or illness within 4 weeks before screening that may affect safety or study results
- Any malignancy within 12 months except certain treated skin or prostate cancers
- Planned major surgery during the study period
- Pregnancy, breastfeeding, or intention to become pregnant during the study
- Positive tests for hepatitis B surface antigen, hepatitis B or C antibodies, or HIV
- Chronic active infections such as HIV, hepatitis, or tuberculosis
- Poor peripheral venous access
- Vital signs outside specified blood pressure or pulse ranges after rest
- Body weight change ≥5% within 3 months before screening
- Significant laboratory abnormalities or abnormal ECGs
- Use of prohibited medications or hormone therapies causing metabolic interference
- Participation in another clinical trial within 30 days or PET imaging trial within 12 months
- Positive alcohol screening or history of alcohol/drug abuse
- History or current use of anabolic steroids
- Recent plasma or blood donation within specified timeframes
- Unlikely to comply with trial procedures
- For cohorts 2-5: unstable or interfering medical conditions, certain liver function abnormalities, and immune-mediated inflammatory diseases except mild or inactive cases
- Additional liver-specific exclusion criteria related to stiffness, enzyme levels, kidney function, coagulation, and clinical liver disease status
- For fibrostenotic CD cohort: MRI findings showing only inflammation without fibrostenotic changes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
CTC Karolinska
Stockholm, Sweden, SE-171 64 S
Actively Recruiting
2
CTC Akademiska Uppsala University Hospital, Entrance 85, 2nd level
Uppsala, Sweden, SE-751 85
Not Yet Recruiting
3
Section of Gastroenterology/Hepatology, Uppsala University Hospital
Uppsala, Sweden, SE-751 85
Not Yet Recruiting
Research Team
J
Johan Vessby, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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