Dual Energy Computed Tomography (CT) in Finding Bone Metastases in Patients With Cancer
NCT ID: NCT02354326
Last Updated: 2019-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
16 participants
OBSERVATIONAL
2014-11-07
2017-09-27
Brief Summary
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Detailed Description
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I. Compare the accuracy of single energy CT (SECT) with virtual non-calcium (VNC) double energy CT (DECT) to standard SECT alone in the detection of metastatic bone lesions using positron emission tomography (PET)-CT as the reference standard.
OUTLINE:
Computed tomography (CT) scans are routinely used in the evaluation of oncologic patients for initial diagnosis and subsequent disease staging. Detection of bone metastasis on standard CT, however, is limited in sensitivity, particularly in case of osteolytic intramedullary lesions. Recent studies have shown the ability to detect bone marrow edema using CT with the use of a virtual non-calcium (VNC) dual energy CT (DECT) technique. Because bone marrow edema is similar in composition to intramedullary bone metastases (i.e. both are of soft tissue composition as opposed to calcium or fat), VNC DECT may also be helpful in the detection of bone marrow metastasis. Cancer patients obtaining a Positron Emission Tomography (PET) CT and a separate diagnostic CT scan as part of their routine clinical care will be enrolled into the study. The diagnostic CT scan will be performed on a DECT scanner and the images will be reconstructed as SECT images for routine clinical interpretation as well as VNC DECT images. The SECT images alone will be evaluated and scored, and then the VNC DECT images will be added to the SECT images for a second evaluation (consecutive reading session). Multiple readers blinded to the PET-CT findings for detection of bony metastatic disease will participate.
Researchers hypothesize the addition of VNC DECT to SECT will be more accurate in the detection of metastatic bone marrow lesions compared to SECT alone.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Diagnostic (VNC DECT)
Patients undergo CT scans. Additional images will be processed with virtual non-calcium (VNC) dual energy CT (DECT) information. Comparison will be made between images with and without addition of VNC.
virtual non-calcium dual-energy computed tomography
Undergo VNC DECT
computed tomography
Undergo CT without VNC
Interventions
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virtual non-calcium dual-energy computed tomography
Undergo VNC DECT
computed tomography
Undergo CT without VNC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with bone metastases on PET/CT
* Patients without bone metastases on PET/CT
* All cancer types and both newly diagnosed and previously treated patients will be included
Exclusion Criteria
* Time between the diagnostic CT and PET/CT greater than 30 days
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Naveen Subhas, MD
Role: PRINCIPAL_INVESTIGATOR
Case Comprehensive Cancer Center
Locations
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Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2014-02497
Identifier Type: REGISTRY
Identifier Source: secondary_id
CASE5Y14
Identifier Type: OTHER
Identifier Source: secondary_id
CASE5Y14
Identifier Type: -
Identifier Source: org_study_id
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