MesotheliomaNCT03867578
Magnetic Resonance Imaging for Detection of Peritoneal Mesothelioma
A study testing HR-MRI, Standard CT Imaging and Ultrasound in people with Mesothelioma and Peritoneal Mesothelioma, run by University of Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesothelioma, Peritoneal Mesothelioma
- What is being tested?
- HR-MRI, Standard CT Imaging and Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2018to 20 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University Of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
About this study
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
- Being tested
- HR-MRI, Standard CT Imaging, Ultrasound
- Medical subject headings
- Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR-MRIDiagnostic 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 ImagingDiagnostic test
Standard CT scans will be performed for preoperative imaging in all patients.
UltrasoundDiagnostic test
Ultrasound Elastography will be performed using an FDA-Approved diagnostic GE ultrasound scanner
| Study group | Role | What they receive |
|---|---|---|
| Exploratory Phase - Standard CT Imaging and HR-MRI | Other | The goal is to test several different novel Magnetic Resonance sequences to determine which gives the best visualization of peritoneal disease. Receives: Diagnostic Test: HR-MRI; Diagnostic Test: Standard CT Imaging |
| Testing Phase- Conventional and HR-MRI and Ultrasound | Other | Patients will undergo conventional and HR-MRI imaging as well as abdominal ultrasound to define the performance of these methods. Receives: Diagnostic Test: HR-MRI; Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 Days
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.
Measured: 60 Days
Secondary outcomes (4)
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
Measured: 60 days
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
Measured: 60 days
Perform Ultrasound Elastography in peritoneal mesothelioma to determine optimal strain ratios
Ultrasound Elastography to determine optimal strain ratios to maximize sensitivity in PM patients
Measured: 60 days
Perform Ultrasound Elastography in peritoneal mesothelioma to determine elasticity scores
Ultrasound Elastography to determine elasticity scores to maximize sensitivity in PM patients
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start10 Oct 2018
- Primary completion20 Jul 2022
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MesotheliomaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hedy Kindler, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867578
- Sponsor's protocol ID
- IRB18-1101
- Status last verified
- Jul 2024
- First submitted
- 5 Mar 2019
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging for Detection of Peritoneal Mesothelioma
- ClinicalTrials.gov ID
- NCT03867578
- Acronym / sponsor ID
- IRB18-1101
- Conditions
- Mesothelioma, Peritoneal Mesothelioma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 8 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exploratory Phase - Standard CT Imaging and HR-MRI | Other | Diagnostic Test: HR-MRI, Diagnostic Test: Standard CT ImagingThe goal is to test several different novel Magnetic Resonance sequences to determine which gives the best visualization of peritoneal disease. |
| Testing Phase- Conventional and HR-MRI and Ultrasound | Other | Diagnostic Test: HR-MRI, Diagnostic Test: UltrasoundPatients will undergo conventional and HR-MRI imaging as well as abdominal ultrasound to define the performance of these methods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HR-MRIThe 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 | Exploratory Phase - Standard CT Imaging and HR-MRI, Testing Phase- Conventional and HR-MRI and Ultrasound |
| Standard CT ImagingStandard CT scans will be performed for preoperative imaging in all patients. | Diagnostic test | Exploratory Phase - Standard CT Imaging and HR-MRI |
| UltrasoundUltrasound Elastography will be performed using an FDA-Approved diagnostic GE ultrasound scanner | Diagnostic test | Testing Phase- Conventional and HR-MRI and Ultrasound |
Primary outcome
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.
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.
4 secondary outcomes
The performance of diffusion-weighted MRI in detecting peritoneal disease in patients with malignant peritoneal mesothelioma
Time frame: 60 days
Test high-definition small-voxel MRI imaging sequences for detection of peritoneal disease in MPM
Time frame: 60 days
Perform Ultrasound Elastography in peritoneal mesothelioma to determine optimal strain ratios
Time frame: 60 days
Perform Ultrasound Elastography in peritoneal mesothelioma to determine elasticity scores
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hedy Kindler, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HR-MRI, Standard CT Imaging and Ultrasound in people with Mesothelioma and Peritoneal Mesothelioma, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Higher Sensitivity for detection using New High Resolution Contrast Enhanced MRI Imaging Sequences compared to standard MRI (time frame: 60 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.