DECT in Imaging Patients With Solid Organ Cancer With Intracranial Metastasis

Study Overview
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Brief Summary
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This trial studies how well dual energy computed tomography (DECT) works in imaging patients with solid organ cancer that has spread to the brain. Imaging techniques, such as DECT, may help find and diagnose tumor cells and find out how far the tumor cells have spread in the brain.

Detailed Description
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PRIMARY OBJECTIVES: I. To optimize two major parameters of computed tomography (CT) imaging for optimal detection of intracranial metastatic lesions. Ia. Virtual monochromatic image reconstruction. Ib. Contrast bolus timing. II. To measure the detection accuracy of CT compared to the diagnostic standard of care gadolinium-based Gamma Knife (GK) protocol magnetic resonance imaging (MRI). OUTLINE: Within 7 days before the standard Gamma Knife MRI, patients undergo DECT scan over 6 seconds at 1.5, 5, 10, and 20 minutes after receiving the contrast agent.

Official Title
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Advanced CT Imaging Optimization for the Detection of Intracranial Metastasis

Conditions
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Malignant Neoplasm, Metastatic Malignant Neoplasm in the Brain

Intervention / Treatment
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* Procedure: Dual-Energy Computed Tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient with pathology-proven solid organ cancer MRI of the brain with contrast, positive for two or more metastatic lesions One lesion with a single greatest diameter on contrast-enhanced MRI of 1 cm or greater Planned treatment with stereotactic radiosurgery Exclusion Criteria: Known allergy to iodine-based contrast agents Patients with glomerular filtration rate (GFR) less than 30 or use of hemodialysis If prior nephrectomy, GFR less than 60 Prior central nervous system malignancy Prior brain radiation Pregnant women are excluded

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (DECT)<br>Within 7 days before the standard Gamma Knife MRI, patients undergo DECT scan over 6 seconds at 1.5, 5, 10, and 20 minutes after receiving the contrast agent. | Procedure: Dual-Energy Computed Tomography<br>* Undergo DECT<br>* Other names: DECT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best diagnostic performance of computed tomography (CT) reconstruction parameters | A repeated-measures analysis of variance with the Dunnett post hoc test will be used to determine the significance of the differences in the signal-to-noise (SNR) and contrast-to-noise (CNR) measurements at the optimal parameter setting, compared with all other parameter settings. | Up to 2 years | 
| Accuracy of CT | A Bland-Altman analysis will be used to show the agreement of number of lesions between optimal parametrized CT and the one of standard of care magnetic resonance imaging (MRI). | Up to 2 years |