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Diffusion MRI of the Abdomen

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ClinicalTrials.gov Identifier: NCT05261633
Recruitment Status : Not yet recruiting
First Posted : March 2, 2022
Last Update Posted : August 3, 2022
Sponsor:
Collaborator:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment
Abdominal Imaging Device: Diffusion Weighted Magnetic Resonance Imaging

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diffusion Magnetic Resonance Imaging (MRI) of the Abdomen
Estimated Study Start Date : May 2023
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Healthy Volunteers Device: 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 Name: DW-MRI

Known Liver Metastases Device: 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 Name: DW-MRI




Primary Outcome Measures :
  1. Squared difference between each pair of repeated ADC measurements [ Time Frame: up to 1.5 hours ]
    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).


Secondary Outcome Measures :
  1. Mean Squared Error of ADC in images from Healthy Volunteers [ Time Frame: up to 1.5 hours ]
    Optimized bh, M1 and M2 parameters in healthy volunteers by minimization of the mean squared error and bias of ADC quantification across the liver.

  2. Image Quality Score in images from Healthy Volunteers [ Time Frame: up to 1.5 hours ]
    Optimized motion-corrected averaging in healthy volunteers via image quality assessment by three radiologists using a Likert scale, ranging between 0 (worst/non-diagnostic) and 4 (best).

  3. Signal-to-Noise Ratio (SNR) [ Time Frame: up to 1.5 hours ]
    SNR will be evaluated for each DW-MRI dataset, using an expectation-maximization method, accounting for parallel imaging, spatially varying noise, and magnitude operation

  4. Cross-correlation coefficient (CCC) of images [ Time Frame: up to 1.5 hours ]
    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.

  5. Overall Image Quality Score [ Time Frame: up to 1.5 hours ]
    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.

  6. Sensitivity: Number of True Positive Assessments divided by Number of All Positive Assessments [ Time Frame: up to 1.5 hours ]
    Per-lesion sensitivity will be assessed for each DW-MRI method. McNemar's test will be used to compare the sensitivity and specificity between methods.

  7. Specificity: Number of True Negative Assessments divided by Number of All Negative Assessments [ Time Frame: up to 1.5 hours ]
    Per-lesion specificity will be assessed for each DW-MRI method. McNemar's test will be used to compare the sensitivity and specificity between methods.

  8. Accuracy: Number of Correct Assessments divided by Number of All Assessments [ Time Frame: up to 1.5 hours ]
    Per-lesion accuracy will be assessed for each DW-MRI method. McNemar's test will be used to compare the sensitivity and specificity between methods.

  9. Repeat ADC Measurements to Assess Intra-Reader Variability [ Time Frame: up to 1.5 hours ]
    Intra-reader variability will be assessed by each reader with repeating ADC measurements after two months

  10. ACD Measures For Each Reader to assess Inter-Reader Variability [ Time Frame: up to 1.5 hours ]
    Inter-reader variability will be assessed in ADC measurements by comparing matching lesions, based on the recorded lesion location across readers.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers and people with known liver metastases that are 18 years or older.
Criteria

Inclusion Criteria for Healthy Volunteers:

  • 18 years of age or older

Exclusion Criteria for 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)

Inclusion Criteria for Patients:

  • 18 years of age or older
  • Known liver metastasis/ metastases

Exclusion Criteria for Patients:

  • 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)
  • Stent in bile ducts
  • Partial hepatectomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05261633


Contacts
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Contact: Gemma Gliori (608) 262-7269 ggliori@uwhealth.org

Locations
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United States, Wisconsin
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Investigators
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Principal Investigator: Diego Hernando, PhD University of Wisconsin, Madison
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT05261633    
Other Study ID Numbers: 2021-1289
Protocol Version 6/26/2021 ( Other Identifier: UW Madison )
A539300 ( Other Identifier: UW Madison )
1R01EB030497-01 ( U.S. NIH Grant/Contract )
First Posted: March 2, 2022    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No