Condition or disease | Intervention/treatment | Phase |
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Recurrent Malignant Thymoma Thymoma | Procedure: Diaphragm Fluoroscopy Procedure: Magnetic Resonance Imaging | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Can MRI Replace CT in the Evaluation of Thymoma? |
Actual Study Start Date : | June 8, 2011 |
Estimated Primary Completion Date : | June 30, 2021 |
Estimated Study Completion Date : | June 30, 2021 |
Arm | Intervention/treatment |
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Experimental: Diagnostic (MRI, diaphragm fluoroscopy)
Patients undergo an MRI scan over 45-60 minutes and a diaphragm fluoroscopy 30 days before surgery.
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Procedure: Diaphragm Fluoroscopy
Undergo diaphragm fluoroscopy
Other Name: Sniff Test
Procedure: Magnetic Resonance Imaging Undergo MRI
Other Names:
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
M D Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Marcelo F Benveniste | M.D. Anderson Cancer Center |
Tracking Information | |||||
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First Submitted Date ICMJE | May 28, 2019 | ||||
First Posted Date ICMJE | May 30, 2019 | ||||
Last Update Posted Date | May 30, 2019 | ||||
Actual Study Start Date ICMJE | June 8, 2011 | ||||
Estimated Primary Completion Date | June 30, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Accuracy of magnetic resonance imaging (MRI) staging [ Time Frame: 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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | An Investigational Scan (MRI) in Imaging Patients With Newly-Diagnosed or Recurrent Thymoma | ||||
Official Title ICMJE | Can MRI Replace CT in the Evaluation of Thymoma? | ||||
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Diagnostic (MRI, diaphragm fluoroscopy)
Patients undergo an MRI scan over 45-60 minutes and a diaphragm fluoroscopy 30 days before surgery.
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE |
40 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | June 30, 2021 | ||||
Estimated Primary Completion Date | June 30, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03968315 | ||||
Other Study ID Numbers ICMJE | 2011-0360 NCI-2019-02643 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2011-0360 ( Other Identifier: M D Anderson Cancer Center ) P30CA016672 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | M.D. Anderson Cancer Center | ||||
Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
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PRS Account | M.D. Anderson Cancer Center | ||||
Verification Date | May 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |