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

Primary Purpose

Recurrent Malignant Thymoma, Thymoma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diaphragm Fluoroscopy
Magnetic Resonance Imaging
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Recurrent Malignant Thymoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (MRI, diaphragm fluoroscopy)

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 28, 2019
Last Updated
September 19, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03968315
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 8, 2011 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Malignant Thymoma, Thymoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (MRI, diaphragm fluoroscopy)
Arm Type
Experimental
Arm Description
Patients undergo an MRI scan over 45-60 minutes and a diaphragm fluoroscopy 30 days before surgery.
Intervention Type
Procedure
Intervention Name(s)
Diaphragm Fluoroscopy
Other Intervention Name(s)
Sniff Test
Intervention Description
Undergo diaphragm fluoroscopy
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Intervention Description
Undergo MRI
Primary Outcome Measure Information:
Title
Accuracy of magnetic resonance imaging (MRI) staging
Description
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.
Time Frame
Up to 10 years
Secondary Outcome Measure Information:
Title
Accuracy of phrenic nerve paralysis by functional MRI
Description
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.
Time Frame
Up to 10 years
Title
Accuracy of fast novel MRI sequences
Description
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.
Time Frame
Up to 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo F Benveniste
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website

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

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