Magnetic Resonance Imaging for Detection of Peritoneal Mesothelioma

Study Overview
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Brief Summary
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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.

Official Title
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Magnetic Resonance Imaging for Detection of Peritoneal Mesothelioma

Conditions
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Mesothelioma, Peritoneal Mesothelioma

Intervention / Treatment
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* Diagnostic Test: HR-MRI
* Diagnostic Test: Standard CT Imaging
* Diagnostic Test: Ultrasound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Exploratory Phase - Standard CT Imaging and HR-MRI<br>The goal is to test several different novel Magnetic Resonance sequences to determine which gives the best visualization of peritoneal disease. | Diagnostic Test: HR-MRI<br>* 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.<br>Diagnostic Test: Standard CT Imaging<br>* Standard CT scans will be performed for preoperative imaging in all patients.<br>|
| Other: Testing Phase- Conventional and HR-MRI and Ultrasound<br>Patients will undergo conventional and HR-MRI imaging as well as abdominal ultrasound to define the performance of these methods. | Diagnostic Test: HR-MRI<br>* 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.<br>Diagnostic Test: Ultrasound<br>* Ultrasound Elastography will be performed using an FDA-Approved diagnostic GE ultrasound scanner<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Higher Sensitivity for detection using New High Resolution Contrast Enhanced MRI Imaging Sequences compared to standard MRI | New HR-MRI sequences will demonstrate greater sensitivity than standard MRI for detecting peritoneal metastases. | 60 Days | 
| Higher sensitivity for detection of peritoneal metastatic disease using Ultrasound Elastography compared to standard MRI | Ultrasound Elastography will demonstrate greater sensitivity than standard MRI for detecting peritoneal metastases. | 60 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The performance of diffusion-weighted MRI in detecting peritoneal disease in patients with malignant peritoneal mesothelioma | Use diffusion-weighted MRI in detecting the per-region sensitivity in patients with MPM | 60 days | 
| Test high-definition small-voxel MRI imaging sequences for detection of peritoneal disease in MPM | To test HR-MRI sequences for detection of peritoneal disease in MPM focusing on the right hemidiaphragmatic and pelvic spaces | 60 days | 
| Perform Ultrasound Elastography in peritoneal mesothelioma to determine optimal strain ratios | Ultrasound Elastography to determine optimal strain ratios to maximize sensitivity in PM patients | 60 days | 
| Perform Ultrasound Elastography in peritoneal mesothelioma to determine elasticity scores | Ultrasound Elastography to determine elasticity scores to maximize sensitivity in PM patients | 60 days |