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CompletedNCT03867578Updated Jul 31, 2024

Magnetic Resonance Imaging for Detection of Peritoneal Mesothelioma

An interventional study of HR-MRI and Standard CT Imaging in Mesothelioma and Peritoneal Mesothelioma, sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-31.

Sponsored by University of Chicago · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Oct 2018, registered Mar 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Mesothelioma
  • Peritoneal Mesothelioma

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03

In context

Mesothelioma

475 studies on the registry are indexed under Mesothelioma; 75 are open to participants now.

This study's enrollment of 26 is below the median of 40 across 376 interventional studies indexed under Mesothelioma.

Browse Mesothelioma studies →

Lead sponsor

University of Chicago is the lead sponsor of 924 studies on the registry; 186 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 71 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Other
    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 · Diagnostic Test: Standard CT Imaging

  • Other
    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 · Diagnostic Test: Ultrasound

Interventions

  • Diagnostic testHR-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 testStandard CT Imaging

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

  • Diagnostic testUltrasound

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 60 Days

  2. 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.

    Time frame: 60 Days

Secondary outcomes

  1. 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

    Time frame: 60 days

  2. 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

    Time frame: 60 days

  3. Perform Ultrasound Elastography in peritoneal mesothelioma to determine optimal strain ratios

    Ultrasound Elastography to determine optimal strain ratios to maximize sensitivity in PM patients

    Time frame: 60 days

  4. Perform Ultrasound Elastography in peritoneal mesothelioma to determine elasticity scores

    Ultrasound Elastography to determine elasticity scores to maximize sensitivity in PM patients

    Time frame: 60 days

07

Study locations

1 site
  • University Of Chicago Medicine Comprehensive Cancer Center
    Chicago, Illinois 60637, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2018 to primary completion in Jul 2022, 45 months.

Of 21 interventional studies with no phase under Mesothelioma, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 141. This study's 45 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 5, 2019
First posted
Mar 8, 2019
StartActual
Oct 10, 2018
Primary completionActual
Jul 20, 2022
CompletionActual
Jul 20, 2022
Last update
Jul 31, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03867578
Responsible party
Sponsor
First posted
Mar 8, 2019
Start date
Oct 10, 2018
Primary completion
Jul 20, 2022
Completion
Jul 20, 2022
Last update
Jul 31, 2024

Study contacts

Hedy Kindler, MD
principal investigator · University of Chicago

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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