Magnetic Resonance Imaging for Detection of Peritoneal Mesothelioma

Mesothelioma Clinical Trial

Official title:

Magnetic Resonance Imaging for Detection of Peritoneal Mesothelioma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03867578
• Other study ID #: IRB18-1101
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 10, 2018
• Est. completion date: January 22, 2025

Study information

• Verified date: August 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: January 22, 2025
• Est. primary completion date: August 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mesothelioma
• Mesothelioma, Malignant
• Peritoneal Mesothelioma

Intervention

Diagnostic Test:
• 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.
• Standard CT Imaging
Standard CT scans will be performed for preoperative imaging in all patients.
• Ultrasound
Ultrasound Elastography will be performed using an FDA-Approved diagnostic GE ultrasound scanner

Locations

Country	Name	City	State
United States	University Of Chicago Medicine Comprehensive Cancer Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Perform Ultrasound Elastography in peritoneal mesothelioma to determine elasticity scores	Ultrasound Elastography to determine elasticity scores to maximize sensitivity in PM patients	60 days