Actively Recruiting
A First-In-Human Microdosing Trial Investigating Binding of the PET Tracer [68Ga]Ga-DOTA-CYS-ATH001 Targeting PDGFR in Healthy Subjects Compared to Patients With MASH, PSC, and Crohn's Disease
Led by Antaros Medical · Updated on 2024-08-29
30
Participants Needed
3
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the binding of a new PET tracer called [68Ga]Ga-DOTA-Cys-ATH001 in the liver and gastrointestinal tract. The study compares healthy volunteers with patients who have metabolically caused steatohepatitis (MASH), fibrostenotic Crohn's Disease (CD), and primary sclerosing cholangitis (PSC). This first-in-human, phase 0, multi-center trial aims to understand tracer uptake patterns and assess its safety and distribution in the body. Participants receive a single intravenous injection of up to 100 micrograms of the tracer, followed by PET and MRI scans to visualize tracer binding and body function. Some participants in specific cohorts undergo a second injection and imaging visit within six weeks to test tracer reliability. Blood samples are collected from certain groups to measure tracer levels over time. Safety assessments and remote follow-up calls are also part of the study protocol. During the study, participants will have health checks and eligibility screening before dosing. Imaging includes whole-body PET/MRI scans and specific examinations like FibroScan for some groups. Safety is monitored through vital signs, ECG, lab tests, and injection site observations. Follow-up calls check on any side effects or medication use. The trial involves 2 to 3 visits depending on the participant's cohort and includes detailed assessments of tracer uptake and pharmacokinetics.
CONDITIONS
Brief 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 give 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 practice abstinence
- Male participants must use condoms, be vasectomized, or practice sexual abstinence to prevent pregnancy
- Cohort 1: Medically healthy without significant medical history or abnormal findings
- Cohort 2: Presumed MASH patients with steatosis and at least one cardiometabolic risk factor
- Cohort 3: Verified MASH patients with biopsy or imaging confirmed steatosis and cardiometabolic risk
- Cohort 4: Fibrostenotic Crohn's Disease patients confirmed by MRI or colonoscopy with low disease activity
- Cohort 5: PSC patients with large duct PSC confirmed by MRI/MRCP and elevated ProC3 marker
You will not qualify if you...
- Contraindications for MRI including claustrophobia, metallic implants, inability to lie supine for 90 minutes, and permanent makeup interfering with imaging
- History of working as a metal worker or welder
- Any significant disease or disorder that may risk safety or affect trial results
- Recent illness, surgery, or trauma within 4 weeks of screening
- Malignancy within past 12 months except certain skin or prostate cancers
- Planned major surgery during trial participation
- Pregnant, breastfeeding, or intending pregnancy during trial
- Positive test for hepatitis B, C, or HIV
- Chronic active infections
- Poor venous access
- Abnormal vital signs outside specified blood pressure or pulse ranges
- Body weight change of 5% or more within 3 months before screening
- Significant laboratory or ECG abnormalities
- Use of prohibited medications or hormone therapies that interfere metabolically
- Participation in another trial within 30 days or PET imaging trial within 12 months
- Positive alcohol screening or history of alcohol or drug abuse
- Recent plasma or blood donation
- Likely non-compliance with trial procedures
- Additional exclusions for cohorts 2-5 include unstable liver function, abnormal liver biochemistry, severe immune diseases, and specific disease-related criteria
- Cohort 4 exclusion: MRI findings showing only inflammation without fibrosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single intravenous bolus injection of up to 100 µg [68Ga]Ga-DOTA-Cys-ATH001 followed by whole-body PET/MRI scans and safety assessments.
1 visit (in-person)
Duration - 1 day
Participants are contacted by telephone the day after dosing to follow up on adverse events, injection site reactions, and concomitant medication.
1 remote follow-up call
Duration - 1 day within 6 weeks after first treatment
Participants in the test/retest sub-groups (cohorts 1b and 2b) receive a second intravenous bolus injection of up to 100 µg [68Ga]Ga-DOTA-Cys-ATH001 with PET/MRI scans and safety assessments within 6 weeks of the first treatment.
1 visit (in-person)
Duration - 1 day
Participants in the test/retest sub-groups are contacted by telephone the day after their second dosing to follow up on adverse events, injection site reactions, and concomitant medication.
1 remote follow-up call
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
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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