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Completed

NCT Number: NCT03685539

DECT in Imaging Patients With Solid Organ Cancer With Intracranial Metastasis

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.

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Key information

Conditions

Malignant Neoplasm Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Metastatic Malignant Neoplasm in the Brain Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dual-Energy Computed Tomography

Procedure

Undergo DECT

Other names: DECT

Primary outcomes

  1. Best diagnostic performance of computed tomography (CT) reconstruction parameters

    Time frame: 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.

  2. Accuracy of CT

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Advanced CT Imaging Optimization for the Detection of Intracranial Metastasis

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Sep 26, 2018
Registry last updated
Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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