DECT in Imaging Patients With Solid Organ Cancer With Intracranial Metastasis

August 30, 2023 updated by: M.D. Anderson Cancer Center

Advanced CT Imaging Optimization for the Detection of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (DECT)
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
Undergo DECT
Other Names:
  • DECT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 2 years
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).
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Jason M Johnson, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2018

Primary Completion (Actual)

August 29, 2023

Study Completion (Actual)

August 29, 2023

Study Registration Dates

First Submitted

September 21, 2018

First Submitted That Met QC Criteria

September 24, 2018

First Posted (Actual)

September 26, 2018

Study Record Updates

Last Update Posted (Estimated)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-0303 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2018-01984 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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