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Clinical Trials/NCT03867578
NCT03867578
Completed
Not Applicable

Magnetic Resonance Imaging for Detection of Peritoneal Mesothelioma

University of Chicago1 site in 1 country26 target enrollmentOctober 10, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mesothelioma
Sponsor
University of Chicago
Enrollment
26
Locations
1
Primary Endpoint
Higher Sensitivity for detection using New High Resolution Contrast Enhanced MRI Imaging Sequences compared to standard MRI
Status
Completed
Last Updated
last year

Overview

Brief Summary

For cancers, such as mesothelioma, that spread to the lining of the stomach, detecting the cancer is very difficult with CT or MRI scans. Researchers at the University of Chicago want to find out if the new experimental MRI and ultrasound imaging techniques do a better job of detecting these cancers. Researchers will use new MRI and ultrasound techniques to see if it can find evidence of cancer that has spread to the lining of the abdomen, and right now these new techniques are only used for research.

Registry
clinicaltrials.gov
Start Date
October 10, 2018
End Date
July 20, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 18 years old or older
  • Biopsy-proven MPM
  • Surgery for PM planned at UCM within 60 days
  • Able to tolerate CT, MRI, US scans, and surgery
  • Able to provide written informed consent
  • For women of child bearing age, ability and willingness to use appropriate contraceptive methods before imaging and for a period of 365 days thereafter.

Exclusion Criteria

  • Pregnancy / Breastfeeding
  • Allergy or intolerance to iodinated or gadolinum contrast dyes
  • Contraindications to CT or MRI imaging including chronic kidney disease with GFR \<60mL/min/1.73m2
  • Bioimplants unsuitable for MRI imaging (activated by mechanical, electronic, radiofrequency, or magnetic means), such as cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps
  • Permanent tattoos or eyeliner with magnetic dyes
  • Subjects with shrapnel or metal fragments lodged in the body
  • Anxiety, claustrophobia, or any medical condition that would preclude lying still in an MRI scanner for 1-1.5 hours
  • Cardiac, circulatory, or perspiration problems leading to impaired thermoregulation
  • Respiratory or cardiac impairment limiting the ability to lie flat
  • Inability to breath-hold for MRI acquisition

Outcomes

Primary Outcomes

Higher Sensitivity for detection using New High Resolution Contrast Enhanced MRI Imaging Sequences compared to standard MRI

Time Frame: 60 Days

New HR-MRI sequences will demonstrate greater sensitivity than standard MRI for detecting peritoneal metastases.

Higher sensitivity for detection of peritoneal metastatic disease using Ultrasound Elastography compared to standard MRI

Time Frame: 60 Days

Ultrasound Elastography will demonstrate greater sensitivity than standard MRI for detecting peritoneal metastases.

Secondary Outcomes

  • Test high-definition small-voxel MRI imaging sequences for detection of peritoneal disease in MPM(60 days)
  • The performance of diffusion-weighted MRI in detecting peritoneal disease in patients with malignant peritoneal mesothelioma(60 days)
  • Perform Ultrasound Elastography in peritoneal mesothelioma to determine elasticity scores(60 days)
  • Perform Ultrasound Elastography in peritoneal mesothelioma to determine optimal strain ratios(60 days)

Study Sites (1)

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