MRI Imaging for Thymoma

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Children, Pregnant, Metal in chest, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the accuracy of MRI scans (Magnetic Resonance Imaging) in detecting the spread of thymoma, a type of tumor in the chest, compared to traditional CT scans. MRI scans may provide more detailed images of the tumor, aiding doctors in planning better treatments. The trial seeks adults consulting a thoracic surgeon for surgery on a newly diagnosed or recurring thymoma. Participants will undergo a 45-60 minute MRI scan and a diaphragm fluoroscopy 30 days before surgery. As an unphased trial, it offers participants the chance to contribute to advancing imaging techniques that could enhance future treatment planning.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that MRI imaging is safe for diagnosing thymoma?

Research has shown that MRI scans are safe and generally easy for patients to handle. Studies have found that MRI excels at revealing details inside the chest, particularly for thymoma, a type of tumor in the thymus gland. The MRI procedure itself has no known harmful effects. Unlike CT scans, MRI does not use radiation, making it a safer option.

Patients who have undergone MRI scans have not reported any serious side effects. Some might feel a bit uncomfortable staying still inside the MRI machine for 45 to 60 minutes, but this is not harmful. Overall, MRI is considered a safe and effective method for examining thymoma in the chest. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using MRI imaging for thymoma because it offers a non-invasive way to gather detailed images of the thymus gland, potentially improving the accuracy of thymoma diagnosis. Unlike traditional imaging methods like CT scans, MRI does not use ionizing radiation, making it safer for repeated use. Additionally, MRI can provide clearer images of soft tissues, helping to better differentiate thymoma from other conditions, which can be crucial for planning effective treatment.

What evidence suggests that MRI is effective for imaging thymoma?

Research has shown that MRI scans outperform CT scans in detecting thymomas, which are tumors in the chest. One study found that MRI correctly identified 96.4% of cases, while CT scans identified 86.7%. This indicates that MRI is more effective at distinguishing thymomas from other chest issues. Additionally, MRI excels at differentiating between thymic cysts (fluid-filled sacs) and solid lumps, which CT scans often confuse. Overall, MRI provides a clearer view of the tumor's size and spread, aiding doctors in making better treatment decisions. Participants in this trial will undergo an MRI scan as part of the diagnostic process. ^{1 6 7 8 9}

Who Is on the Research Team?

Marcelo F Benveniste

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with newly diagnosed or recurrent thymoma who are scheduled for surgery at MD Anderson Cancer Center. It's not open to those under 18, pregnant women, patients with metal in their chest or pacemakers, known allergies to MRI contrast agents (gadolinium), or severe kidney issues.

Inclusion Criteria

I am scheduled for surgery at MD Anderson for a new or recurring thymoma.

Exclusion Criteria

Pregnant patients

Patients with a known allergic reaction to gadolinium, who will have their MRI performed without contrast

Patients with an allergy to iodinated contrast material will follow departmental routine policy, that is those with anaphylaxis will have their CT performed without intravenous contrast and others will be prepped as for departmental guidelines for routine chest CT

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic

Patients undergo an MRI scan over 45-60 minutes and a diaphragm fluoroscopy 30 days before surgery

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after diagnostic procedures

Up to 10 years

What Are the Treatments Tested in This Trial?

Interventions

• Magnetic Resonance Imaging

Trial Overview

The study is testing the effectiveness of an MRI scan versus a standard CT scan in accurately imaging and assessing the spread of thymoma within the chest before surgical removal.

How Is the Trial Designed?

Group I: Diagnostic (MRI, diaphragm fluoroscopy) Experimental Treatment 2 Interventions

Patients undergo an MRI scan over 45-60 minutes and a diaphragm fluoroscopy 30 days before surgery.

Magnetic Resonance Imaging is already approved in United States for the following indications:

Approved in United States as Lumakras (sotorasib) for:

• Non-small cell lung cancer with KRAS G12C mutation

Approved in United States as Vectibix (panitumumab) for:

• Advanced colorectal cancer that is wild-type RAS

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study involving 17,767 patients across 45 European centers, only 30 acute adverse reactions (0.17%) were reported after administering gadolinium-based contrast agents during cardiac magnetic resonance imaging, all classified as mild.

The most common reactions included rashes, hives, nausea, and anxiety, with the incidence of adverse events being comparable to that seen in general radiology settings, indicating that the off-label use of these agents in CMR is safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute adverse reactions to gadolinium-based contrast agents in CMR: multicenter experience with 17,767 patients from the EuroCMR Registry. Bruder, O., Schneider, S., Nothnagel, D., et al.[2016]

Whole-body magnetic resonance imaging (WB-MRI) is a radiation-free imaging technique that can effectively detect and characterize lesions in less than 40 minutes, making it a valuable tool in cancer management.

International guidelines now recommend WB-MRI for various cancers, including multiple myeloma and prostate cancer, due to its superior ability to evaluate treatment responses and screen high-risk patients compared to traditional imaging methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-body magnetic resonance imaging: technique, guidelines and key applications. Summers, P., Saia, G., Colombo, A., et al.[2021]

In a study of 4,832 outpatients undergoing contrast-enhanced MRI, the use of a patient-friendly audiovisual (AV) system significantly reduced the rate of adverse reactions to gadolinium-based contrast agents from 1.6% in the control group to 0.7% in the AV group.

While the AV system decreased the occurrence of adverse reactions, it did not affect the severity of these reactions, indicating that the AV system is effective in improving patient experience without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship Between Patient-Friendly Audiovisual Systems and MRI Contrast Agent to Adverse Reactions. Nitta, K., Matsumoto, K., Yokota, H., et al.[2023]

Citations

1.

i-mri.org

i-mri.org/DOIx.php?id=10.13104/imri.2024.0029

:: iMRI :: Investigative Magnetic Resonance Imaging

On DW-MRI with ADC mapping, thymomas often exhibit restricted diffusion due to increased cellularity, resulting in lower ADC values than those ...

2.

frontiersin.org

frontiersin.org/journals/oncology/articles/10.3389/fonc.2021.810419/full

Imaging Evaluation of Thymoma and Thymic Carcinoma

On MRI, thymic cysts demonstrate increased T2 signal, variable T1 signal depending on protein content, and no appreciable wall or nodular ...

3.

ajronline.org

ajronline.org/doi/10.2214/AJR.10.4703

MRI of the Thymus | AJR

Differentiation of thymic cysts from solid lesions is more readily and consistently achieved with MRI. Hyperdense thymic cysts are often misinterpreted as solid ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0009926015004948

Comparison of CT and chemical-shift MRI for differentiating ...

At qualitative assessment, MRI had higher accuracy than CT (96.4%, 80/83 and 86.7%, 72/83, respectively). At quantitative analysis, both the radiodensity and ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8799001/

The value of enhanced computed tomography combined ...

Enhanced CT combined with MRI is superior to enhanced CT or MRI alone for preoperative differential diagnosis of thymomas and thymic cysts with diameters of <5 ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03968315

An Investigational Scan (MRI) in Imaging Patients With ...

This trial studies the accuracy of a magnetic resonance imaging (MRI) scan in imaging the inside of the chest in patients with thymoma that is newly diagnosed ...

7.

frontiersin.org

frontiersin.org/journals/neurology/articles/10.3389/fneur.2018.01173/full

Correlation Between Thymus Radiology and Myasthenia ...

Additionally, MRI is 100% sensitive to thymoma, and MRI is better than the other methods in terms of thymoma specificity and accuracy. Therefore ...

8.

mdpi.com

mdpi.com/2227-9032/12/20/2036

Upfront Thoracic Magnetic Resonance Imaging for the ...

This narrative review outlines the current approaches to the evaluation of thymic lesions, with a discussion of the strengths and limitations of CT and MRI ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6603368/

Comparison between CT and MRI in the Diagnostic ...

The diagnostic accuracy of MRI is superior to CT in detecting thymomas, thymic cysts or thymic hyperplasia but that of CT and MRI is still unclear.