Diffusion MRI of the Abdomen

NCT05261633 | Recruiting FDA Device

• 4 other identifiers: 2021-1289Protocol Version 10/17/2025A5393001R01EB030497-01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to see if a new magnetic resonance imaging (MRI) method will be able to improve the images taken of the abdomen. This new method includes some changes to help avoid movements that may disrupt the images like breathing, heartbeats and other involuntary motion that occurs in the abdomen. This study will these methods in healthy volunteers and validate them in patients with known liver metastases in a single contrast-enhanced MRI visit.

Conditions

Abdominal Imaging

Outcome Measures

Primary Outcomes (1)

• Squared difference between each pair of repeated ADC measurements

  Compare the repeatability of DW-MRI methods by calculating the squared difference between each pair of repeated apparent diffusion coefficient (ADC) measurements in lesions and healthy tissue, and will model this value including the DW-MRI method as a covariate using Generalized Estimating Equations (GEE).

  up to 1.5 hours

Secondary Outcomes (10)

• Mean Squared Error of ADC in images from Healthy Volunteers

  up to 1.5 hours

• Image Quality Score in images from Healthy Volunteers

  up to 1.5 hours

• Signal-to-Noise Ratio (SNR)

  up to 1.5 hours

• Cross-correlation coefficient (CCC) of images

  up to 1.5 hours

• Overall Image Quality Score

  up to 1.5 hours

Study Arms (2)

Healthy Volunteers

Device: Diffusion Weighted Magnetic Resonance Imaging

Known Liver Metastases

Device: Diffusion Weighted Magnetic Resonance Imaging

Interventions

Diffusion Weighted Magnetic Resonance Imaging DEVICE

Diffusion-weighted (DW)-MRI has a unique ability to probe tissue microstructure without the need for ionizing radiation or intravenous contrast agents. DW-MRI of the abdomen is utilized in detection, staging, and treatment surveillance of malignancies, and has shown great promise in various other applications, including for the assessment of fibrosis in the liver, pancreas, kidneys, and other organs.

Also known as: DW-MRI

Healthy Volunteers; Known Liver Metastases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers and people with known liver metastases that are 18 years or older.

You may qualify if:

• years of age or older

You may not qualify if:

• 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)
• years of age or older
• Patients with at least one of the following:
• Radiologically visible solid tumor liver metastasis, with at least one metastatic liver lesion must be a minimum of 8 mm in longest diameter
• Patients presenting for liver lesion biopsy
• Patients with contraindication to MRI (e.g. pacemaker, contraindicated metallic implants, claustrophobia, etc)
• Patients with known contraindication to GBCA such as severe kidney disease or previously documented GFR \< 30 ml/min/1.73 m2
• 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 subject 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
• Pregnant or trying to become pregnant (as determined by self-report during MRI safety screening)
• Stent in bile ducts
• Partial hepatectomy

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

RECRUITING

MeSH Terms

Interventions

Diffusion Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Diego Hernando, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Radiology Studies

CONTACT

608-282-8349; Radstudy@uwhealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: March 2, 2022
• Study Start: November 22, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)