Magnetic Resonance Imaging for Detection of Peritoneal Mesothelioma

NCT03867578 | Completed

• 1 other identifier: IRB18-1101
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Mesothelioma; Peritoneal Mesothelioma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

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

  60 days

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

  60 days

• Perform Ultrasound Elastography in peritoneal mesothelioma to determine optimal strain ratios

  60 days

• Perform Ultrasound Elastography in peritoneal mesothelioma to determine elasticity scores

  60 days

Study Arms (2)

Exploratory Phase - Standard CT Imaging and HR-MRI

OTHER

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; Diagnostic Test: Standard CT Imaging

Testing Phase- Conventional and HR-MRI and Ultrasound

OTHER

Patients will undergo conventional and HR-MRI imaging as well as abdominal ultrasound to define the performance of these methods.

Diagnostic Test: HR-MRI; Diagnostic Test: Ultrasound

Interventions

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.

Exploratory Phase - Standard CT Imaging and HR-MRI; Testing Phase- Conventional and HR-MRI and Ultrasound

Standard CT Imaging DIAGNOSTIC_TEST

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

Exploratory Phase - Standard CT Imaging and HR-MRI

Ultrasound DIAGNOSTIC_TEST

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

Testing Phase- Conventional and HR-MRI and Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University Of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Mesothelioma

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Hedy Kindler, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 8, 2019
• Study Start: October 10, 2018
• Primary Completion: July 20, 2022
• Study Completion: July 20, 2022
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

US (1)