Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
80 participants
OBSERVATIONAL
2023-11-22
2026-06-30
Brief Summary
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Detailed Description
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The primary objective is to demonstrate precise quantitative diffusion parameter mapping that is achieved by the novel, motion-robust, low-distortion DW-MRI methods in a representative and clinically relevant application, for the assessment of liver metastatic disease. Specifically, the investigators will:
1\. Compare the repeatability of DW-MRI methods by calculating the squared difference between each pair of repeated 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).
Secondary objectives include optimization of the methods in healthy volunteers, assessment of image quality and distortions, as well gathering preliminary data for assessment of sensitivity and specificity for detection of lesions:
1. Optimization in healthy volunteers
1. (Aim 1) Optimized bh, M1 and M2 parameters by minimization of the mean squared error and bias of ADC quantification across the liver
2. (Aim 2) Optimized motion-corrected averaging via image quality assessment by three radiologists using a Likert scale.
2. SNR (signal-to-noise ratio) will be evaluated for each DW-MRI dataset, using an expectation-maximization method, accounting for parallel imaging, spatially varying noise, and magnitude operation.
3. To assess image distortions in DW-MRI, the cross-correlation coefficient (CCC) will be used to assess alignment between each of the DW-MRI datasets and the reference T2-weighted acquisition.
4. Each DW-MRI reconstruction will be evaluated by three radiologists using a Likert scale between 0 (worst/non-diagnostic) and 4 (best) for several criteria: motion artifacts, spatial resolution, distortions, apparent SNR, and overall image quality. The post-contrast images will serve as a guide to assess for artifacts by demonstrating the liver and the lesions.
5. Per-lesion sensitivity, specificity, and accuracy will be assessed for each DW-MRI method. McNemar's test will be used to compare the sensitivity and specificity between methods.
6. Intra-reader variability will be assessed by each reader will repeating ADC measurements after two months.
7. Inter-reader variability will be assessed in ADC measurements by comparing matching lesions, based on the recorded lesion location across readers.
Specific Aims Aim 1: Optimize a reliable, motion-robust DW-MRI of the abdomen in healthy volunteers.
Aim 2: Optimize, in healthy volunteers, a high-resolution, low-distortion, motion-robust DW-MRI of the abdomen through the synergistic combination of motion-robust DW-MRI with state-of-the-art low-distortion techniques.
Aim 3: Demonstrate excellent image quality and precise quantitative diffusion parameter mapping using the novel DW-MRI methods in a representative and clinically relevant application for the assessment of liver metastases, by evaluating in patients:
3a. Quantitative and subjective image quality metrics. 3b. Precision (test-retest repeatability) of ADC measurements in the liver (including healthy parenchyma and lesions) by novel vs. standard DW-MRI methods.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthy Volunteers
Diffusion Weighted Magnetic Resonance Imaging
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.
Known Liver Metastases
Diffusion Weighted Magnetic Resonance Imaging
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.
Interventions
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Diffusion Weighted Magnetic Resonance Imaging
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 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
Exclusion Criteria
* Pregnant or trying to become pregnant (as determined by self-report during MRI safety screening)
* 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
18 Years
ALL
Yes
Sponsors
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National Institute for Biomedical Imaging and Bioengineering (NIBIB)
NIH
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Diego Hernando, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States
Countries
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Central Contacts
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Other Identifiers
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Protocol Version 10/17/2025
Identifier Type: OTHER
Identifier Source: secondary_id
A539300
Identifier Type: OTHER
Identifier Source: secondary_id
2021-1289
Identifier Type: -
Identifier Source: org_study_id