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MRI Imaging for Thymoma
N/A
Waitlist Available
Led By Marcelo F Benveniste
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Be older than 18 years old
Must not have
Children, defined as individuals younger than 18 years old on the preoperative visit with the thoracic surgeon
Patients with glomerular filtration rate (GFR) < 60 ml/min, who will have their MRI performed without contrast
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether MRI is more accurate than CT in imaging the inside of the chest in patients with thymoma.
Who is the study for?
This trial is for adults with newly diagnosed or recurrent thymoma who are scheduled for surgery at MD Anderson Cancer Center. It's not open to those under 18, pregnant women, patients with metal in their chest or pacemakers, known allergies to MRI contrast agents (gadolinium), or severe kidney issues.
What is being tested?
The study is testing the effectiveness of an MRI scan versus a standard CT scan in accurately imaging and assessing the spread of thymoma within the chest before surgical removal.
What are the potential side effects?
There may be minimal side effects from the MRI procedure itself; however, individuals allergic to gadolinium might experience reactions if contrast is used. Kidney function could also be affected by contrasts used during imaging.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for surgery at MD Anderson for a new or recurring thymoma.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am under 18 years old and have seen a thoracic surgeon.
Select...
My kidney function is reduced, so my MRI will be without contrast.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Accuracy of magnetic resonance imaging (MRI) staging
Secondary study objectives
Accuracy of fast novel MRI sequences
Accuracy of phrenic nerve paralysis by functional MRI
Side effects data
From 2022 Phase 3 trial • 53 Patients • NCT0003329319%
87900-Vomiting(targeted toxicity)
15%
11400-Agitation
8%
58700-Nystagmus
8%
16800-Bladder infection
8%
11600-Alanine aminotransferase increased
8%
44800-Infections and infestations - Other specify
4%
58300-Neutrophil count decreased
4%
41400-Hyperglycemia(targeted toxicity)
4%
69700-Rash maculo-papular(targeted toxicity)
4%
33900-Fever
4%
33300-Febrile neutropenia
4%
20500-Catheter related infection
4%
42600-Hypoalbuminemia
4%
43100-Hypokalemia
4%
88500-White blood cell decreased
4%
41300-Hypercalcemia
4%
42700-Hypocalcemia
4%
15300-Ataxia
4%
64400-Personality change
4%
13200-Anemia
4%
57600-Nausea(targeted toxicity)
4%
13500-Anorexia
4%
15000-Aspartate aminotransferase increased
4%
25700-Diarrhea
4%
41600-Hyperkalemia
4%
41500-Hyperhidrosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Chemotherapy, Immunoglobulin Therapy)
Arm II (Chemotherapy, Observation)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Diagnostic (MRI, diaphragm fluoroscopy)Experimental Treatment2 Interventions
Patients undergo an MRI scan over 45-60 minutes and a diaphragm fluoroscopy 30 days before surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,927 Previous Clinical Trials
41,017,992 Total Patients Enrolled
22 Trials studying Thymoma
2,724 Patients Enrolled for Thymoma
M.D. Anderson Cancer CenterLead Sponsor
3,067 Previous Clinical Trials
1,802,606 Total Patients Enrolled
3 Trials studying Thymoma
76 Patients Enrolled for Thymoma
Marcelo F BenvenistePrincipal InvestigatorM.D. Anderson Cancer Center
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