Clinical trial NCT03968315: An Investigational Scan (MRI) in Imaging Patients With Newly-Diagnosed or Recurrent Thymoma
Official title: Can MRI Replace CT in the Evaluation of Thymoma?
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Recurrent Malignant Thymoma
Thymoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-05-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of magnetic resonance imaging (MRI) staging
timeFrame: Up to 10 years
Secondary outcomes:
measure: Accuracy of phrenic nerve paralysis by functional MRI
timeFrame: Up to 10 years
measure: Accuracy of fast novel MRI sequences
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Marcelo F Benveniste
role: PRINCIPAL_INVESTIGATOR
References: