Magnetic Resonance Imaging for Detection of Peritoneal Mesothelioma

NCT ID: NCT03867578

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-10
• Study Completion Date: 2022-07-20

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Exploratory Phase - Standard CT Imaging and HR-MRI

The goal is to test several different novel Magnetic Resonance sequences to determine which gives the best visualization of peritoneal disease.

Group Type: OTHER

HR-MRI

Intervention Type: 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

Intervention Type: DIAGNOSTIC_TEST

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

Testing Phase- Conventional and HR-MRI and Ultrasound

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

Group Type: OTHER

HR-MRI

Intervention Type: 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.

Ultrasound

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

HR-MRI

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.

Intervention Type: DIAGNOSTIC_TEST

Standard CT Imaging

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

Intervention Type: DIAGNOSTIC_TEST

Ultrasound

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hedy Kindler, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University Of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

IRB18-1101

Identifier Type: -

Identifier Source: org_study_id