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Liver Micro Flow - MRI

25. srpna 2026 aktualizováno: University of Wisconsin, Madison

Magnetic Resonance Imaging (MRI)-Based Quantification of Perfusion and Microstructure

This study integrates and evaluates a series of novel MRI methods for quantifying blood perfusion and tissue microstructure. The proposed perfusion and microstructure measures may provide biomarkers for fibrosis, cirrhosis, portal hypertension, and response to treatment. The precision of these methods will be evaluated in 110 participants, including healthy volunteers, people with chronic liver disease (CLD), and people with liver fibrosis.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

The overall goal of this project is to develop a next-generation, confounder-corrected Intravoxel incoherent motion (IVIM)-MRI method for quantification of tissue perfusion and microstructure, and to validate this method in patients with CLD. This protocol will address these unmet needs through the following specific aims:

Aim 1: Develop and optimize confounder-corrected IVIM to enable precise quantification over the entire liver.

Aim 2: Validate the technical and clinical performance of confounder-corrected IVIM in patients with CLD.

Aim 3: Demonstrate confounder-corrected IVIM as a marker of intrahepatic vascular resistance in patients with CLD, including those with and without portal hypertension.

Primary Objectives:

  1. Repeatability of confounder-corrected IVIM [repeatability coefficient]
  2. Reproducibility of IVIM across acquisition parameters [coefficient of reproducibility]
  3. Ability to predict histological features (fibrosis stage) of CLD [area under the curve (AUC), optimal cutoffs, sensitivity, specificity]
  4. Determine the response to a meal challenge in patients without and with portal hypertension [pre vs post meal change of IVIM parameters evaluated using mixed effects modeling]

Typ studie

Pozorovací

Zápis (Odhadovaný)

110

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Spojené státy
    • Wisconsin
      • Madison, Wisconsin, Spojené státy, 53792
        • University of Wisconsin

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Metoda odběru vzorků

Ukázka pravděpodobnosti

Studijní populace

Healthy volunteers, patients with chronic liver disease across the Metabolic dysfunction-associated steatoic liver disease (MASLD) spectrum, including steatosis, steatohepatitis (MASH), fibrosis, cirrhosis, and portal hypertension.

Popis

Inclusion Criteria (Healthy Volunteers):

  • Age 7 years or older
  • Willing and able to complete study procedures

Exclusion Criteria (Healthy Volunteers):

  • Patients with contraindication to MRI (e.g. pacemaker, contraindicated metallic implants, claustrophobia, etc)
  • Pregnant or trying to become pregnant (as determined by self-report during MRI safety screening)
  • Received ferumoxytol injection within previous one year (clinical or research)

  • Patients requiring intravenous (IV) conscious sedation for imaging are not eligible; patients requiring mild, oral anxiolytics for the MRI will be allowed to participate as long as the following criteria are met:

    • The person has their own prescription for the medication.
    • The informed consent process is conducted prior to the self-administration of this medication
    • They come to the research visit with a driver

Inclusion Criteria (Participants with CLD):

  • Age 7 years or older
  • Willing and able to complete study procedures
  • Clinical evidence of MASLD, MASH, cirrhosis or liver fibrosis

Exclusion Criteria (Participants with CLD):

  • Patients with contraindication to MRI (e.g. pacemaker, contraindicated metallic implants, claustrophobia, etc)
  • Pregnant or trying to become pregnant (as determined by self-report during MRI safety screening)
  • Received ferumoxytol injection within previous one year (clinical or research)

  • Patients requiring intravenous (IV) conscious sedation for imaging are not eligible; patients requiring mild, oral anxiolytics for the MRI will be allowed to participate as long as the following criteria are met:

    • The person has their own prescription for the medication.
    • The informed consent process is conducted prior to the self-administration of this medication
    • They come to the research visit with a driver

Inclusion Criteria (Liver Fibrosis Spectrum):

  • Age 7 years or older
  • Willing and able to complete study procedures

  • Known or suspected liver steatosis, steatohepatitis, fibrosis, cirrhosis, or portal hypertension, based on clinical imaging from the previous 6 months or histology over the previous 12 months.

    • At least N=50 will be selected based on having a clinically indicated liver biopsy
  • If taking beta blocker medication, willing to temporarily discontinue the medication for three days prior to the research visit after providing informed consent and in consultation with their treating physician.

Exclusion Criteria (Liver Fibrosis Spectrum):

  • Patients with contraindication to MRI (e.g. pacemaker, contraindicated metallic implants, claustrophobia, etc)
  • Pregnant or trying to become pregnant (as determined by self-report during MRI safety screening)
  • Received ferumoxytol injection within previous one year (clinical or research)

  • Patients requiring intravenous (IV) conscious sedation for imaging are not eligible; patients requiring mild, oral anxiolytics for the MRI will be allowed to participate as long as the following criteria are met:

    • The person has their own prescription for the medication.
    • The informed consent process is conducted prior to the self-administration of this medication
    • They come to the research visit with a driver

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
Healthy Volunteers
Healthy participants without known liver disease undergoing a single research visit with non contrast MRI to support development, optimization, and evaluation of MRI based perfusion and microstructure measurements.
Přístroj: Novel MRI Software
  • Each study visit will last approximately 2 hours
  • The visit will include approximately 1 hour of MR imaging
  • Participants will be asked to fast for 5 hours prior to the research visit
Ostatní jména:
  • nekontrastní MRI
Participants with CLD
Participants with chronic liver disease undergoing a single research visit with non contrast MRI to evaluate repeatability and reproducibility of MRI based perfusion and microstructure measurements.
Přístroj: Novel MRI Software
  • Each study visit will last approximately 2 hours
  • The visit will include approximately 1 hour of MR imaging
  • Participants will be asked to fast for 5 hours prior to the research visit
Ostatní jména:
  • nekontrastní MRI
Participants with Liver Fibrosis
Participants with known or suspected liver fibrosis or portal hypertension undergoing a single research visit with non contrast MRI to evaluate imaging performance across the fibrosis spectrum. A subset of participants will also undergo a standardized meal challenge with pre and post meal imaging.
Přístroj: Novel MRI Software
  • Each study visit will last approximately 2 hours
  • The visit will include approximately 1 hour of MR imaging
  • Participants will be asked to fast for 5 hours prior to the research visit
Ostatní jména:
  • nekontrastní MRI
Jiný: Ensure Plus Nutrition Shake
A subset of participants (N=15 with portal hypertension and N=15 without portal hypertension) from the Liver Fibrosis Cohort will be imaged in the fasted state, then exit the scanner where they will be asked to drink two Ensure Plus Nutrition shake. After a 20-minute delay, each subject will re-enter the scanner for additional imaging.
Ostatní jména:
  • Meal challenge

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Test-retest repeatability of IVIM parameters: Perfusion Fraction
Časové okno: data collected over one hour during one study visit
Test-retest repeatability of IVIM parameters will be acquired during a single study visit, summarized using repeatability coefficients and Bland-Altman analysis.
data collected over one hour during one study visit
Test-retest repeatability of IVIM parameters: Blood Velocity Standard Deviation
Časové okno: data collected over one hour during one study visit
Test-retest repeatability of IVIM parameters will be acquired during a single study visit, summarized using repeatability coefficients and Bland-Altman analysis.
data collected over one hour during one study visit
Test-retest repeatability of IVIM parameters: Diffusion Coefficient
Časové okno: data collected over one hour during one study visit
Test-retest repeatability of IVIM parameters will be acquired during a single study visit, summarized using repeatability coefficients and Bland-Altman analysis.
data collected over one hour during one study visit

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Reproducibility of IVIM across acquisition parameters
Časové okno: data collected over one hour during one study visit
Consistency of IVIM measurements across MRI acquisition parameters (relevant parameters include: respiratory motion mitigation approach (respiratory triggered vs free-breathing), and/or spatial resolution, and/or diffusion weighting values), summarized using coefficients of reproducibility and variation.
data collected over one hour during one study visit
Diagnostic performance for liver fibrosis: AUC
Časové okno: data collected over one hour during one study visit
Diagnostic performance for liver fibrosis: Ability of IVIM parameters to differentiate histologic stages of liver fibrosis using ROC analysis.
data collected over one hour during one study visit
Diagnostic performance for liver fibrosis: Sensitivity (True Positive Rate)
Časové okno: data collected over one hour during one study visit
Diagnostic performance for liver fibrosis: Ability of IVIM parameters to differentiate histologic stages (for example: distinguish stages 0-1 from stages 2-4) of liver fibrosis using ROC analysis.
data collected over one hour during one study visit
Diagnostic performance for liver fibrosis: Specificity (True Negative Rate)
Časové okno: data collected over one hour during one study visit
Diagnostic performance for liver fibrosis: Ability of IVIM parameters to differentiate histologic stages (for example: distinguish stages 0-1 from stages 2-4) of liver fibrosis using ROC analysis.
data collected over one hour during one study visit
Response to Meal Challenge in Participants with and without Portal Hypertension
Časové okno: data collected over one hour during one study visit (pre and post meal imaging)
Change in IVIM derived perfusion parameters before and after a standardized meal challenge in participants with and without portal hypertension, evaluated using mixed effects modeling.
data collected over one hour during one study visit (pre and post meal imaging)
Image Quality
Časové okno: data collected over one hour during one study visit
Radiologist rated image quality using a 5 point Likert scale assessing motion, distortion, apparent SNR, and overall quality. Scored from 1-5 with higher scores meaning better quality.
data collected over one hour during one study visit

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Wisconsin, Madison

Spolupracovníci

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Vyšetřovatelé

  • Vrchní vyšetřovatel: Diego Hernando, PhD, UW School of Medicine and Public Health

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

15. ledna 2027

Primární dokončení (Odhadovaný)

1. května 2029

Dokončení studie (Odhadovaný)

1. května 2029

Termíny zápisu do studia

První předloženo

2. června 2026

První předloženo, které splnilo kritéria kontroly kvality

2. června 2026

První zveřejněno (Aktuální)

9. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

26. srpna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

25. srpna 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 2026-0346
  • R01EB037002 (Grant/smlouva NIH USA)
  • Protocol Version 4/14/26 (Jiný identifikátor: UW Madison)
  • SMPH | Radiology (Jiný identifikátor: UW Madison)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ano

produkt vyrobený a vyvážený z USA

Ano

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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