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DECT in Imaging Patients With Solid Organ Cancer With Intracranial Metastasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03685539
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : August 19, 2019
Sponsor:
Collaborator:
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:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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 : May 31, 2020
Estimated Study Completion Date : May 31, 2020

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
Criteria

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


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

Locations
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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)
Investigators
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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 )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019

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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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Neoplasms