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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 : February 27, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE September 21, 2018
First Posted Date  ICMJE September 26, 2018
Last Update Posted Date February 27, 2023
Actual Study Start Date  ICMJE August 24, 2018
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • 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.
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: September 24, 2018)
  • Best diagnostic performance of computed tomography (CT) reconstruction parameters [ Time Frame: Up to 2 years ]
    Parameter setting with largest signal-to-noise ratio SNR) or contrast-to-noise ratio (CNR) will be called the optimal setting for SNR or CNR, respectively.
  • 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 contrast-to-noise (CNR) measurements at the optimal parameter setting, compared with all other parameter settings.
  • 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).
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DECT in Imaging Patients With Solid Organ Cancer With Intracranial Metastasis
Official Title  ICMJE Advanced CT Imaging Optimization for the Detection of Intracranial Metastasis
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Malignant Neoplasm
  • Metastatic Malignant Neoplasm in the Brain
Intervention  ICMJE Procedure: Dual-Energy Computed Tomography
Undergo DECT
Other Name: DECT
Study Arms  ICMJE 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.
Intervention: Procedure: Dual-Energy Computed Tomography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 24, 2018)		 50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jason Johnson 713-792-8443 jjohnson12@mdanderson.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03685539
Other Study ID Numbers  ICMJE 2018-0303
NCI-2018-01984 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0303 ( Other Identifier: M D Anderson Cancer Center )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party M.D. Anderson Cancer Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE M.D. Anderson Cancer Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Jason M Johnson M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date February 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP