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

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.

Start Date01 Aug 2024

Sponsor / Collaborator

Antaros Medical AB

NCT06022263

/ RecruitingPhase 1

A Prospective, Randomised, Double-blinded, Placebo-controlled Study Investigating the Safety and Tolerability of STA363 in Patients With Radiculopathy Caused by Lumbar Disc Herniation

The goal of this clinical trial is to establish safety and tolerability of STA363 injected into a herniated intervertebral disc in patients with sciatica due to disc herniation. The main questions the trial aims to answer are:
Is the treatment safe and tolerable?
Does the volume of the disc and the herniation decrease?
Is sciatica reduced? Participants will be given an injection into the herniated disc of either placebo or STA363 (one dose).
Researchers will compare safety, tolerability, effects on disc and herniation volume and on symptoms between the group of patients injected with placebo and the group injected with STA363.

Start Date25 Jul 2023

Sponsor / Collaborator

Stayble Therapeutics AB

[+3]

NCT04307797

/ CompletedPhase 4IIT

A Pilot Study on the Effect of Glucagon and Glucagon-like Peptide-1 Co-agonism on Cardiac Function and Metabolism in Overweight Participants with Type 2 Diabetes (COCONUT)

The study seeks to explore the cardiovascular effects of co-agonism at the glucagon and (glucagon-like peptide-1) GLP-1 receptor. Glucagon and exenatide will be intravenously infused into participants with type 2 diabetes (T2DM). Overall, the aim of the study is to further the investigator's understanding on the role these endogenous substances have on normal cardiac physiology, myocardial energetics and myocardial glucose uptake through a series of PET and MRI imaging studies

Start Date18 Jan 2022

Sponsor / Collaborator

Cambridge University Hospitals NHS Foundation Trust

[+1]

100 Clinical Results associated with Antaros Medical AB

0 Patents (Medical) associated with Antaros Medical AB

Literatures (Medical) associated with Antaros Medical AB

23 May 2024·Nephrology Dialysis Transplantation

#444 Novel MRI filtration fraction method to assess glomerular hemodynamics in diabetic kidney disease

Author: Hulthe, Johannes ; Makvandi, Kianoush ; Hockings, Paul ; Unwin, Robert John ; Baid-Agrawal, Seema

AbstractBackground and AimsFiltration fraction (FF) is the ratio of the glomerular filtration rate (GFR) to renal plasma flow (RPF) and is therefore an important measure of glomerular hemodynamics. The gold standard method to assess effective RPF is renal clearance of para-aminohippuric acid (PAH) but technical and labour-intensive difficulties limit its application [1]. Quicker and simpler assays of FF are needed, particularly to assess the renal hemodynamic dysfunction (hyper- or hypofiltration) and effects/mode of action of therapeutic interventions in chronic kidney disease (CKD). We assessed a novel magnetic resonance imaging (MRI) technique to measure FF in patients with diabetic kidney disease (DKD) and healthy controls (HC) [2].MethodThis cross-sectional sub-study included 32 DKD subjects with measured GFR (mGFR) ≤ 60 ml/ min/1.73 m2 and stratified into the following GFR stages as per the Kidney Disease Improving Global Outcomes (KDIGO) classification: stage G3a (mGFR 45-59 ml/ min/1.73 m2, n = 3), G3b (mGFR 30-44 ml/ min/1.73 m2, n = 8), G4 (mGFR 15-29 ml/ min/1.73 m2, n = 15), G5 (<15 ml/ min/1.73 m2, n = 6), and 18 age-, gender-matched HC with mGFR ≥ 60 ml/min/1.73 m2. All subjects were 18-79 years old. mGFR was assessed using iohexol clearance. Renal blood flow (RBF) (ml/min) was measured by a 5-minute add-on phase contrast MRI of the renal artery of each kidney and then summed together. RBF was corrected for Body Surface Area. RPF and FF were calculated as below:${\rm{RPF }} = {\rm{ RBF}} \times \ ( {1\ -{\rm{ Hematocrit}}} )$${\rm{FF}} = {\rm{mGFR}}/{\rm{RPF}}$ResultsRBF and mGFR were highly correlated (R2 = 0.70, Fig. 1). FF was 17.1% for HC and decreased with increasing degrees of renal impairment (Fig. 2). While the difference between HC and G3a DKD group was not significant, there was highly significant difference between HC and all other DKD groups (p < 0.001). The standard deviation in the G3a group was relatively large with only 3 subjects in this group.ConclusionThe phase contrast MRI scan can provide a quick and simple measurement of glomerular hemodynamics and therewith further insights into the pathophysiology of DKD and its progression. Given the limitations of the existing method for assessing renal plasma flow, this MRI method can facilitate the inclusion of filtration fraction in DKD clinical trials. Further, the described method could be used to identify hyperfiltration, a compensatory mechanism that can influence results in clinical trials of DKD.

01 May 2022·Journal of nuclear medicine : official publication, Society of Nuclear MedicineQ1 · MEDICINE

Glucagonlike Peptide-1 Receptor Imaging in Individuals with Type 2 Diabetes.

Q1 · MEDICINE

Article

Author: Antoni, Gunnar ; Johansson, Lars ; Tillner, Joachim ; Wagner, Michael ; Velikyan, Irina ; Berglund, Jan Erik ; Haack, Torsten ; Eriksson, Olof ; Pierrou, Stefan ; Bossart, Martin ; Laitinen, Iina ; Larsen, Philip J.

The glucagonlike peptide-1 receptor (GLP1R) is a gut hormone receptor, intricately linked to regulation of blood glucose homeostasis via several mechanisms.It is an established and emergent drug target in metabolic disease.The PET radioligand ⁶⁸Ga-DO3A-VS-exendin4 (68Ga-exendin4) has the potential to enable longitudinal studies of GLP1R in the human pancreas.⁶⁸Ga-exendin4 PET/CT examinations were performed on overweight-to-obese individuals with type 2 diabetes (n = 13) as part of a larger target engagement study (NCT03350191).A scanning protocol was developed to optimize reproducibility (target amount of 0.5 MBq/kg [corresponding to peptide amount of <0.2μg/kg], blood sampling, and tracer stability assessment).The pancreas and abdominal organs were segmented, and binding was correlated with clin. parameters.Uptake of 68Ga-exendin4 in the pancreas, but not in other abdominal tissues, was high but variable between individuals.There was no evidence of self-blocking of GLP1R by the tracer in this protocol, despite the high potency of exendin4.The results showed that a full dynamic scan can be simplified to a short static scan, potentially increasing throughput and reducing patient discomfort.The ⁶⁸Ga-exendin4 concentration in the pancreas (i.e., GLP1R d.) correlated inversely with the age of the individual and tended to correlate pos. with body mass index.However, the total GLP1R content in the pancreas did not.In summary, we present an optimized and simplified ⁶⁸Ga-exendin4 scanning protocol to enable reproducible imaging of GLP1R in the pancreas.⁶⁸Ga-exendin4 PET may enable quantification of longitudinal changes in pancreatic GLP1R during the development of type 2 diabetes, as well as target engagement studies of novel glucagonlike peptide-1 agonists.

Scandinavian Journal of Gastroenterology

Proteomic signatures for fibrosis in MASLD: a biopsy-proven dual-cohort study

Article

Author: Hockings, Paul ; Gabrysch, Katja ; Blomdahl, Julia ; Hulthe, Johannes ; Nasr, Patrik ; Rorsman, Fredrik ; Fridén, Michael ; Kechagias, Stergios ; Eriksson, Niclas ; Vessby, Johan ; Ekstedt, Mattias ; Åberg, Mikael ; Risérus, Ulf ; Ahlström, Håkan

OBJECTIVESPredicting disease progression in metabolic dysfunction-associated steatotic liver disease (MASLD) is challenging, and current non-invasive tests (NITs) lack the precision to replace liver biopsy. This study aimed to identify plasma biomarkers for different stages of fibrosis using affinity-based proteomics in two biopsy-proven cohorts. The primary objective was to identify biomarkers capable of distinguishing between low-to-no fibrosis (F0-1) and significant fibrosis (F2-4) in MASLD.MATERIALS AND METHODSParticipants in the discovery cohort were recruited from Uppsala University Hospital and Swedish CArdioPulmonary bioImage Study (SCAPIS), while the validation cohort was included from Linköping University Hospital. All participants diagnosed with MASLD underwent liver biopsy and were categorized by fibrosis stage (F0-1 or F2-4). A total of 276 plasma proteins were analyzed using Olink^® panels, with biomarkers identified through ordinal logistic regression, random forest (RF) analysis and the Boruta algorithm.RESULTSThe discovery cohort included 60 participants, with 60% having fibrosis stage F0-1 and 40% having F2-4. The validation cohort had 59 participants, of whom 35 had fibrosis stage F0-1 (59.3%) and 24 had stage F2-4 (40.7%). Five biomarkers were significantly associated with fibrosis stage in the discovery cohort, with four confirmed in the validation cohort. A model combining angiotensin converting enzyme-2 (ACE2), hepatocyte growth factor (HGF) and insulin-like growth factor-binding protein-7 (IGFBP-7) demonstrated strong predictive performance for significant fibrosis (c-statistics 0.82-0.83), outperforming fibrosis-4 (FIB-4) (c-statistics 0.61-0.72).CONCLUSIONSA biomarker model including ACE2, HGF and IGFBP7 shows promise in distinguishing between low-stage and significant fibrosis.

100 Deals associated with Antaros Medical AB

100 Translational Medicine associated with Antaros Medical AB

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[68Ga]Ga-DOTA-Cys-ATH001 ( PDGFRβ )	Cholangitis, Sclerosing More	Phase 1 Clinical

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