DECT in Imaging Patients With Solid Organ Cancer With Intracranial Metastasis

Not Applicable

Completed

• Conditions: Metastatic Malignant Neoplasm in the Brain; Malignant Neoplasm
• Interventions: Procedure: Dual-Energy Computed Tomography

• Registration Number: NCT03685539
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-08-24
• Study First Submitted: 2018-09-21
• Study First Submitted QC: 2018-09-24
• Study First Posted: 2018-09-26
• Status Verified: 2023-08
• Primary Completion: 2023-08-29
• Study Completion: 2023-08-29
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (DECT)	Dual-Energy Computed Tomography	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.

Primary Outcome Measures

Name	Time	Method
Best diagnostic performance of computed tomography (CT) reconstruction parameters	Up to 2 years	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.
Accuracy of CT	Up to 2 years	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).

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States