Magnetic Resonance Imaging for Detection of Peritoneal Mesothelioma
Primary Purpose
Mesothelioma, Peritoneal Mesothelioma
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HR-MRI
Standard CT Imaging
Ultrasound
Sponsored by
About this trial
This is an interventional screening trial for Mesothelioma
Eligibility Criteria
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
Sites / Locations
- University Of Chicago Medicine Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Exploratory Phase - Standard CT Imaging and HR-MRI
Testing Phase- Conventional and HR-MRI and Ultrasound
Arm Description
The goal is to test several different novel Magnetic Resonance sequences to determine which gives the best visualization of peritoneal disease.
Patients will undergo conventional and HR-MRI imaging as well as abdominal ultrasound to define the performance of these methods.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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
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
Perform Ultrasound Elastography in peritoneal mesothelioma to determine optimal strain ratios
Ultrasound Elastography to determine optimal strain ratios to maximize sensitivity in PM patients
Perform Ultrasound Elastography in peritoneal mesothelioma to determine elasticity scores
Ultrasound Elastography to determine elasticity scores to maximize sensitivity in PM patients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03867578
Brief Title
Magnetic Resonance Imaging for Detection of Peritoneal Mesothelioma
Official Title
Magnetic Resonance Imaging for Detection of Peritoneal Mesothelioma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
August 28, 2023 (Actual)
Study Completion Date
January 22, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesothelioma, Peritoneal Mesothelioma
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exploratory Phase - Standard CT Imaging and HR-MRI
Arm Type
Other
Arm Description
The goal is to test several different novel Magnetic Resonance sequences to determine which gives the best visualization of peritoneal disease.
Arm Title
Testing Phase- Conventional and HR-MRI and Ultrasound
Arm Type
Other
Arm Description
Patients will undergo conventional and HR-MRI imaging as well as abdominal ultrasound to define the performance of these methods.
Intervention Type
Diagnostic Test
Intervention Name(s)
HR-MRI
Intervention Description
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
Intervention Name(s)
Standard CT Imaging
Intervention Description
Standard CT scans will be performed for preoperative imaging in all patients.
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultrasound
Intervention Description
Ultrasound Elastography will be performed using an FDA-Approved diagnostic GE ultrasound scanner
Primary Outcome Measure Information:
Title
Higher Sensitivity for detection using New High Resolution Contrast Enhanced MRI Imaging Sequences compared to standard MRI
Description
New HR-MRI sequences will demonstrate greater sensitivity than standard MRI for detecting peritoneal metastases.
Time Frame
60 Days
Title
Higher sensitivity for detection of peritoneal metastatic disease using Ultrasound Elastography compared to standard MRI
Description
Ultrasound Elastography will demonstrate greater sensitivity than standard MRI for detecting peritoneal metastases.
Time Frame
60 Days
Secondary Outcome Measure Information:
Title
The performance of diffusion-weighted MRI in detecting peritoneal disease in patients with malignant peritoneal mesothelioma
Description
Use diffusion-weighted MRI in detecting the per-region sensitivity in patients with MPM
Time Frame
60 days
Title
Test high-definition small-voxel MRI imaging sequences for detection of peritoneal disease in MPM
Description
To test HR-MRI sequences for detection of peritoneal disease in MPM focusing on the right hemidiaphragmatic and pelvic spaces
Time Frame
60 days
Title
Perform Ultrasound Elastography in peritoneal mesothelioma to determine optimal strain ratios
Description
Ultrasound Elastography to determine optimal strain ratios to maximize sensitivity in PM patients
Time Frame
60 days
Title
Perform Ultrasound Elastography in peritoneal mesothelioma to determine elasticity scores
Description
Ultrasound Elastography to determine elasticity scores to maximize sensitivity in PM patients
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hedy Kindler, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Of Chicago Medicine Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Magnetic Resonance Imaging for Detection of Peritoneal Mesothelioma
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