An Investigational Scan (MRI) in Imaging Patients With Newly-Diagnosed or Recurrent Thymoma

Can MRI Replace CT in the Evaluation of Thymoma?

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Thymoma; Recurrent Malignant Thymoma
• Intervention / Treatment: Procedure: Magnetic Resonance Imaging; Procedure: Diaphragm Fluoroscopy

Detailed Description

PRIMARY OBJECTIVES:

I. To determine whether thymoma staging by MRI is as accurate as staging by CT as compared to surgical staging.

SECONDARY OBJECTIVES:

I. To determine whether evaluation of phrenic nerve paralysis by functional MRI is as accurate as the fluoroscopic "sniff test" as compared to surgical evaluation of phrenic nerve involvement.

II. To determine whether fast novel MRI sequences are as accurate as conventional MRI sequences for staging thymoma, when comparing to surgical staging.

OUTLINE:

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

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All adult patients scheduled to meet with a thoracic surgeon from MD Anderson Cancer Center (ACC) for resection of newly diagnosed thymoma or thymoma recurrence in the chest and scheduled for surgery

Exclusion Criteria:

• Children, defined as individuals younger than 18 years old on the preoperative visit with the thoracic surgeon
• Pregnant patients
• Patients unable to understand the consent form
• Patients with metal within the chest and pacemakers
• Patients with a known allergic reaction to gadolinium, who will have their MRI performed without contrast
• Patients with glomerular filtration rate (GFR) < 60 ml/min, 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
• Patients with abnormal renal function will have their CT study perform as per DI's iodinated contrast administration guidelines, and no contrast will be administered with GFR lower than 30 ml/min

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diagnostic (MRI, diaphragm fluoroscopy); Patients undergo an MRI scan over 45-60 minutes and a diaphragm fluoroscopy 30 days before surgery.	Procedure: Magnetic Resonance Imaging; Undergo MRI; Other Names: MRI; Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MRI Scan; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging; Procedure: Diaphragm Fluoroscopy; Undergo diaphragm fluoroscopy; Other Names: Sniff Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of magnetic resonance imaging (MRI) staging	Will be compared to staging done by computed tomography (CT). McNemar's test will be used to compare the accuracy for the following five sets of comparisons: spin echo (SE) T1 compared versus (vs.) liver acquisition with volume acquisition (LAVA)+ in-phase (IP)/out-of-phase (OP), Dixon versus fast spin echo (FSE) T2, LAVA+IP/OP+Dixon vs. SET1+FSET2, LAVA+IP/OP+Dixon vs. computed tomography (CT) scan, and SET1+FSET2 vs. CT scan. A p value less than 0.05 will be defined as significant. A p value less than 0.05 will be defined as significant.	Up to 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of phrenic nerve paralysis by functional MRI	Will be evaluated against the fluoroscopic "sniff test" and compared to surgical evaluation of phrenic nerve involvement. The outcome is the binary indicator of whether the phrenic nerve is involved. The accuracy rate will be calculated for each of the three tested methods. And the method with the highest accuracy will be compared with the method with the medium accuracy and the method with least accuracy separately, using McNemar's test.	Up to 10 years
Accuracy of fast novel MRI sequences	Will be evaluated against conventional MRI sequences for staging thymoma when compared to surgical staging. Will use the pathological stages as gold standard and calculate accuracy for the new shorter MRI sequences and current MRI sequences methods. Accuracy will be compared between two MRI techniques using McNemar's test. And the following five sets of comparisons will be tested: SE T1 compared vs. LAVA+ IP/OP, Dixon versus FSE T2, LAVA+IP/OP+Dixon vs. SET1+FSET2, LAVA+IP/OP+Dixon vs. CT scan, and SET1+FSET2 vs. CT scan. A p value less than 0.05 will be defined as significant.	Up to 10 years

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Marcelo F Benveniste, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2011
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029

Study Registration Dates

• First Submitted: May 28, 2019
• First Submitted That Met QC Criteria: May 28, 2019
• First Posted (Actual): May 30, 2019

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Thoracic Neoplasms; Lymphatic Diseases; Neoplasms, Complex and Mixed; Thymus Neoplasms; Hemic and Lymphatic Diseases; Thymoma; Investigative Techniques; Chemistry Techniques, Analytical; Spectrum Analysis; Magnetic Resonance Spectroscopy
• Other Study ID Numbers: 2011-0360 (Other Identifier: M D Anderson Cancer Center); P30CA016672 (U.S. NIH Grant/Contract); NCI-2019-02643 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No