NCT03968315

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
36mo left

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Jun 2011Apr 2029

Study Start

First participant enrolled

June 8, 2011

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2019

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2029

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

17.9 years

First QC Date

May 28, 2019

Last Update Submit

March 5, 2026

Conditions

Recurrent Malignant ThymomaThymoma

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 10 years

Secondary Outcomes (2)

  • Accuracy of phrenic nerve paralysis by functional MRI

    Up to 10 years

  • Accuracy of fast novel MRI sequences

    Up to 10 years

Study Arms (1)

Diagnostic (MRI, diaphragm fluoroscopy)

EXPERIMENTAL

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

Procedure: Diaphragm FluoroscopyProcedure: Magnetic Resonance Imaging

Interventions

Magnetic Resonance ImagingPROCEDURE

Undergo MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Diagnostic (MRI, diaphragm fluoroscopy)
Diaphragm FluoroscopyPROCEDURE

Undergo diaphragm fluoroscopy

Also known as: Sniff Test
Diagnostic (MRI, diaphragm fluoroscopy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Thymoma

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms, Complex and MixedNeoplasms by Histologic TypeNeoplasmsThymus NeoplasmsThoracic NeoplasmsNeoplasms by SiteLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Marcelo F Benveniste

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2019

First Posted

May 30, 2019

Study Start

June 8, 2011

Primary Completion (Estimated)

April 30, 2029

Study Completion (Estimated)

April 30, 2029

Last Updated

March 9, 2026

Record last verified: 2026-03

Locations

US(1)