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OpenTrials
Completed

NCT Number: NCT03867578

Magnetic Resonance Imaging for Detection of Peritoneal Mesothelioma

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.

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Key information

Conditions

Mesothelioma Adenoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Peritoneal Mesothelioma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Vascular or aneurysm clips or any other surgical implant that is not MRI-compatible
  • Any other ferromagnetic bioimplant that would be damaged by MRI
  • Mental, cognitive, or mental health impairments that preclude the subject from providing informed consent or adhering to the treatment protocol
  • Subjects unable to adhere to the protocol or communicate effectively with researchers
  • Imprisoned subjects
  • Subjects with history of prior CRS/HIPEC or other peritonectomy surgery that might alter characteristics of the peritoneum

Treatment and study plan

HR-MRI

Diagnostic Test

The first 5 patients will undergo HR-MRI scans using different sequence parameters. Results in these patients will then be assessed along with standard CT Imaging to determine which sequences appear to best identify peritoneal disease. The optimal HR-MRI sequences will then be used for the next 19 patients in the Testing phase to formally define their performance compared to standard imaging.

Standard CT Imaging

Diagnostic Test

Standard CT scans will be performed for preoperative imaging in all patients.

Ultrasound

Diagnostic Test

Ultrasound Elastography will be performed using an FDA-Approved diagnostic GE ultrasound scanner

Primary outcomes

  1. 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.

  2. 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

  1. The performance of diffusion-weighted MRI in detecting peritoneal disease in patients with malignant peritoneal mesothelioma

    Time frame: 60 days

    Use diffusion-weighted MRI in detecting the per-region sensitivity in patients with MPM

  2. Test high-definition small-voxel MRI imaging sequences for detection of peritoneal disease in MPM

    Time frame: 60 days

    To test HR-MRI sequences for detection of peritoneal disease in MPM focusing on the right hemidiaphragmatic and pelvic spaces

  3. Perform Ultrasound Elastography in peritoneal mesothelioma to determine optimal strain ratios

    Time frame: 60 days

    Ultrasound Elastography to determine optimal strain ratios to maximize sensitivity in PM patients

  4. Perform Ultrasound Elastography in peritoneal mesothelioma to determine elasticity scores

    Time frame: 60 days

    Ultrasound Elastography to determine elasticity scores to maximize sensitivity in PM patients

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 8, 2019
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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