DECT in Imaging Patients With Solid Organ Cancer With Intracranial Metastasis
Advanced CT Imaging Optimization for the Detection of Intracranial Metastasis
2 other identifiers
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 24, 2018
CompletedFirst Submitted
Initial submission to the registry
September 21, 2018
CompletedFirst Posted
Study publicly available on registry
September 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 29, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 29, 2023
CompletedAugust 31, 2023
August 1, 2023
5 years
September 21, 2018
August 30, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Best diagnostic performance of computed tomography (CT) reconstruction parameters
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
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
Study Arms (1)
Diagnostic (DECT)
EXPERIMENTALWithin 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason M Johnson
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2018
First Posted
September 26, 2018
Study Start
August 24, 2018
Primary Completion
August 29, 2023
Study Completion
August 29, 2023
Last Updated
August 31, 2023
Record last verified: 2023-08