Magnetic Resonance Imaging for Detection of Peritoneal Mesothelioma

Not Applicable

Completed

• Conditions: Peritoneal Mesothelioma; Mesothelioma
• Interventions: Diagnostic Test: HR-MRI; Diagnostic Test: Standard CT Imaging; Diagnostic Test: Ultrasound

• Registration Number: NCT03867578
• Lead Sponsor: University of Chicago

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-10
• Study First Submitted: 2019-03-05
• Study First Submitted QC: 2019-03-05
• Study First Posted: 2019-03-08
• Primary Completion: 2022-07-20
• Study Completion: 2022-07-20
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1. 18 years old or older
2. Biopsy-proven MPM
3. Surgery for PM planned at UCM within 60 days
4. Able to tolerate CT, MRI, US scans, and surgery
5. Able to provide written informed consent
6. 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

1. Pregnancy / Breastfeeding
2. Allergy or intolerance to iodinated or gadolinum contrast dyes
3. Contraindications to CT or MRI imaging including chronic kidney disease with GFR <60mL/min/1.73m2
4. Bioimplants unsuitable for MRI imaging (activated by mechanical, electronic, radiofrequency, or magnetic means), such as cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps
5. Permanent tattoos or eyeliner with magnetic dyes
6. Subjects with shrapnel or metal fragments lodged in the body
7. Anxiety, claustrophobia, or any medical condition that would preclude lying still in an MRI scanner for 1-1.5 hours
8. Cardiac, circulatory, or perspiration problems leading to impaired thermoregulation
9. Respiratory or cardiac impairment limiting the ability to lie flat
10. Inability to breath-hold for MRI acquisition
11. Vascular or aneurysm clips or any other surgical implant that is not MRI-compatible
12. Any other ferromagnetic bioimplant that would be damaged by MRI
13. Mental, cognitive, or mental health impairments that preclude the subject from providing informed consent or adhering to the treatment protocol
14. Subjects unable to adhere to the protocol or communicate effectively with researchers
15. Imprisoned subjects
16. Subjects with history of prior CRS/HIPEC or other peritonectomy surgery that might alter characteristics of the peritoneum

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Testing Phase- Conventional and HR-MRI and Ultrasound	HR-MRI	Patients will undergo conventional and HR-MRI imaging as well as abdominal ultrasound to define the performance of these methods.
Exploratory Phase - Standard CT Imaging and HR-MRI	HR-MRI	The goal is to test several different novel Magnetic Resonance sequences to determine which gives the best visualization of peritoneal disease.
Exploratory Phase - Standard CT Imaging and HR-MRI	Standard CT Imaging	The goal is to test several different novel Magnetic Resonance sequences to determine which gives the best visualization of peritoneal disease.
Testing Phase- Conventional and HR-MRI and Ultrasound	Ultrasound	Patients will undergo conventional and HR-MRI imaging as well as abdominal ultrasound to define the performance of these methods.

Primary Outcome Measures

Name	Time	Method
Higher Sensitivity for detection using New High Resolution Contrast Enhanced MRI Imaging Sequences compared to standard MRI	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	60 Days	Ultrasound Elastography will demonstrate greater sensitivity than standard MRI for detecting peritoneal metastases.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Of Chicago Medicine Comprehensive Cancer Center; 🇺🇸 Chicago, Illinois, United States