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

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Thymoma; Recurrent Malignant Thymoma

Treatments: Procedure: Magnetic Resonance Imaging; Procedure: Diaphragm Fluoroscopy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03968315

P30CA016672 (U.S. NIH Grant/Contract)

2011-0360 (Other Identifier)

NCI-2019-02643 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 1 patient group

Diagnostic (MRI, diaphragm fluoroscopy)

Experimental group

Description:

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

Treatment:

Procedure: Diaphragm Fluoroscopy

Procedure: Magnetic Resonance Imaging