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Magnetic Resonance Imaging for Detection of Peritoneal Mesothelioma

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ClinicalTrials.gov Identifier: NCT03867578
Recruitment Status : Not yet recruiting
First Posted : March 8, 2019
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Mesothelioma Peritoneal Mesothelioma Diagnostic Test: HR-MRI Diagnostic Test: Standard CT Imaging Diagnostic Test: Ultrasound Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Magnetic Resonance Imaging for Detection of Peritoneal Mesothelioma
Estimated Study Start Date : April 22, 2019
Estimated Primary Completion Date : January 22, 2022
Estimated Study Completion Date : January 22, 2024


Arm Intervention/treatment
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.
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.

Diagnostic Test: Standard CT Imaging
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.
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.

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




Primary Outcome Measures :
  1. Higher Sensitivity for detection using New High Resolution Contrast Enhanced MRI Imaging Sequences compared to standard MRI [ Time Frame: 60 Days ]
    New HR-MRI sequences will demonstrate greater sensitivity than standard MRI for detecting peritoneal metastases.

  2. Higher sensitivity for detection of peritoneal metastatic disease using Ultrasound Elastography compared to standard MRI [ Time Frame: 60 Days ]
    Ultrasound Elastography will demonstrate greater sensitivity than standard MRI for detecting peritoneal metastases.


Secondary Outcome Measures :
  1. The performance of diffusion-weighted MRI in detecting peritoneal disease in patients with malignant peritoneal mesothelioma [ Time Frame: 60 days ]
    Use diffusion-weighted MRI in detecting the per-region sensitivity in patients with MPM

  2. Test high-definition small-voxel MRI imaging sequences for detection of peritoneal disease in MPM [ Time Frame: 60 days ]
    To test HR-MRI sequences for detection of peritoneal disease in MPM focusing on the right hemidiaphragmatic and pelvic spaces

  3. Perform Ultrasound Elastography in peritoneal mesothelioma to determine optimal strain ratios [ Time Frame: 60 days ]
    Ultrasound Elastography to determine optimal strain ratios to maximize sensitivity in PM patients

  4. Perform Ultrasound Elastography in peritoneal mesothelioma to determine elasticity scores [ Time Frame: 60 days ]
    Ultrasound Elastography to determine elasticity scores to maximize sensitivity in PM patients



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03867578


Contacts
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Contact: Kiran Turaga, MD 773-702-6771 kturaga@surgery.bsd.uchicago.edu

Locations
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United States, Illinois
University Of Chicago Medicine Comprehensive Cancer Center Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: Kiran Turaga, MD    773-702-6771    kturaga@surgery.bsd.uchicago.edu   
Principal Investigator: Kiran Turaga, MD         
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Kiran Turaga, MD University of Chicago

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03867578     History of Changes
Other Study ID Numbers: IRB18-1101
First Posted: March 8, 2019    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial