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

40 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Magnetic Resonance Imaging for thymoma?

MRI is effective in diagnosing thymomas, as it has a higher specificity than CT scans, meaning it is better at correctly identifying thymic masses. It can also help predict the stage of thymic tumors, which is important for planning treatment. ^{1 2 3 4 5}

Is MRI imaging generally safe for humans?

MRI imaging is generally considered safe because it does not use ionizing radiation, which can be harmful. However, some MRI procedures use contrast agents like gadolinium, which can cause rare allergic reactions. Whole-body MRI is recommended for certain cancers as a safer alternative to other imaging methods. ^{6 7 8 9 10}

How does MRI imaging differ from other treatments for thymoma?

MRI imaging for thymoma is unique because it provides detailed pictures of the thymus without using ionizing radiation or contrast media, which can be important for patients who cannot tolerate contrast agents. It helps in accurately staging the tumor and predicting its behavior, which is crucial for planning treatment. ^{2 3 11 12 13}

What is the purpose of this trial?

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 or has come back. An MRI scan may be able to detect if and how far the tumor has spread more accurately than a standard computed tomography (CT) scan.

Research Team

Marcelo F Benveniste

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

MR imaging of thymic epithelial tumors: correlation with World Health Organization classification. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

Diffusion-weighted magnetic resonance imaging of thymoma: ability of the Apparent Diffusion Coefficient in predicting the World Health Organization (WHO) classification and the Masaoka-Koga staging system and its prognostic significance on disease-free survival. [2020]

3. Japan pubmed.ncbi.nlm.nih.gov

Utility of non-contrast-enhanced magnetic resonance imaging in predicting preoperative clinical stage and prognosis in patients with thymic epithelial tumor. [2023]

4. Australia pubmed.ncbi.nlm.nih.gov

Comparison between CT and MRI in the Diagnostic Accuracy of Thymic Masses. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Diffusion-weighted MR imaging in thymic epithelial tumors: correlation with World Health Organization classification and clinical staging. [2022]

6. Brazil pubmed.ncbi.nlm.nih.gov

Whole-body magnetic resonance imaging for the diagnosis of metastasis in children and adolescents: a systematic review and meta-analysis. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Relationship Between Patient-Friendly Audiovisual Systems and MRI Contrast Agent to Adverse Reactions. [2023]

8. United States 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. [2016]

9. England pubmed.ncbi.nlm.nih.gov

Whole-body magnetic resonance imaging: technique, guidelines and key applications. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Assessment of adverse reaction rates to a newly approved MRI contrast agent: review of 23,553 administrations of gadobenate dimeglumine. [2013]

11. China pubmed.ncbi.nlm.nih.gov

The value of enhanced computed tomography combined with magnetic resonance imaging in the differential diagnosis of thymomas and thymic cysts before operation. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

The Value of CT and MRI for Determining Thymoma in Patients With Myasthenia Gravis. [2020]

13. Australia pubmed.ncbi.nlm.nih.gov

The value of diffusion-weighted and dynamic contrast-enhanced imaging in the diagnosis of thymic epithelial tumors. [2023]