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NCT Number: NCT03968315

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Recurrent Malignant Thymoma Hemic and Lymphatic Diseases Lymphatic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Thoracic Neoplasms Thymoma Thymus Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diaphragm Fluoroscopy

Procedure

Undergo diaphragm fluoroscopy

Other names: Sniff Test

Magnetic Resonance Imaging

Procedure

Undergo MRI

Other names: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Primary outcomes

  1. Accuracy of magnetic resonance imaging (MRI) staging

    Time frame: Up to 10 years

    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.

Secondary outcomes

  1. Accuracy of phrenic nerve paralysis by functional MRI

    Time frame: Up to 10 years

    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.

  2. Accuracy of fast novel MRI sequences

    Time frame: Up to 10 years

    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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Can MRI Replace CT in the Evaluation of Thymoma?

Important dates

Study start
2011
Primary completion
2029
Study completion
2029
First posted
May 30, 2019
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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