Diffusion Magnetic Resonance Imaging (MRI) of the Abdomen
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 17
- Locations
- 2
- Primary Endpoint
- Squared difference between each pair of repeated ADC measurements
Study Overview
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.
Detailed Description
This study will develop and validate novel DW-MRI methods with unprecedented robustness to motion, favorable image quality, and quantitative precision for abdominal imaging. Upon successful completion, these methods will have broad applications, including the assessment of cancer, fibrosis and other disease processes in various abdominal organs such as the liver, pancreas, kidneys, bowel and beyond.
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:
- Optimization in healthy volunteers
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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 for Patients:
- •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
Outcomes
Primary Outcomes
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 Outcomes
- 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)
- Sensitivity: Number of True Positive Assessments divided by Number of All Positive Assessments(up to 1.5 hours)
- Cross-correlation coefficient (CCC) of images(up to 1.5 hours)
- Specificity: Number of True Negative Assessments divided by Number of All Negative Assessments(up to 1.5 hours)
- Accuracy: Number of Correct Assessments divided by Number of All Assessments(up to 1.5 hours)
- Signal-to-Noise Ratio (SNR)(up to 1.5 hours)
- ACD Measures For Each Reader to assess Inter-Reader Variability(up to 1.5 hours)
- Overall Image Quality Score(up to 1.5 hours)
- Repeat ADC Measurements to Assess Intra-Reader Variability(up to 1.5 hours)