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

Not Applicable

Active, not recruiting

• Conditions: Recurrent Malignant Thymoma; Thymoma
• Interventions: Procedure: Diaphragm Fluoroscopy; Procedure: Magnetic Resonance Imaging

• Registration Number: NCT03968315
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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.

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 Timeline

• Study Start: 2011-06-08
• Study First Submitted: 2019-05-28
• Study First Submitted QC: 2019-05-28
• Study First Posted: 2019-05-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (MRI, diaphragm fluoroscopy)	Diaphragm Fluoroscopy	Patients undergo an MRI scan over 45-60 minutes and a diaphragm fluoroscopy 30 days before surgery.
Diagnostic (MRI, diaphragm fluoroscopy)	Magnetic Resonance Imaging	Patients undergo an MRI scan over 45-60 minutes and a diaphragm fluoroscopy 30 days before surgery.

Primary Outcome Measures

Name	Time	Method
Accuracy of magnetic resonance imaging (MRI) staging	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 Outcome Measures

Name	Time	Method
Accuracy of phrenic nerve paralysis by functional MRI	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.
Accuracy of fast novel MRI sequences	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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States