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DECT in Imaging Patients With Solid Organ Cancer With Intracranial Metastasis

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ClinicalTrials.gov Identifier: NCT03685539
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : February 27, 2023
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm Metastatic Malignant Neoplasm in the Brain Procedure: Dual-Energy Computed Tomography Not Applicable

Detailed Description:


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).


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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Advanced CT Imaging Optimization for the Detection of Intracranial Metastasis
Actual Study Start Date : August 24, 2018
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

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 Name: DECT

Primary Outcome Measures :
  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).

Information from the National Library of Medicine

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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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03685539

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Contact: Jason Johnson 713-792-8443 jjohnson12@mdanderson.org

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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jason M. Johnson    713-792-8443      
Principal Investigator: Jason M. Johnson         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Jason M Johnson M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03685539    
Other Study ID Numbers: 2018-0303
NCI-2018-01984 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0303 ( Other Identifier: M D Anderson Cancer Center )
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: February 27, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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