Malignant Neoplasm Clinical Trial
Official title:
Evaluation of Bone Metastases With Dual Energy Computed Tomography (CT)
Verified date | February 2019 |
Source | Case Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This clinical trial studies dual energy computed tomography (CT) in finding cancer that has spread from the original (primary) tumor to the bone (bone metastases) in patients with cancer. Diagnostic procedures, such as dual energy CT, may help find and diagnose bone metastases and may be more accurate compared to single energy CT alone.
Status | Terminated |
Enrollment | 16 |
Est. completion date | September 27, 2017 |
Est. primary completion date | September 27, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients being imaged with PET/CT for diagnosis and/or staging of disease at Case Comprehensive Cancer Center - 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: - Patients with intervening treatment during the time between diagnostic CT and PET/CT - Time between the diagnostic CT and PET/CT greater than 30 days |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Case Comprehensive Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Lesions Present | Number of lesions detected at the 46 designated locations at the time of the VNC DECT | within 30 days of first treatment | |
Primary | Number of lesions absent | Number of absent lesions from the 46 designated locations at the time of the VNC DECT | within 30 days of first treatment | |
Primary | Confidence in the presence of one or more lesions in that particular anatomic location using a 0-100 point confidence scale | Each location will be correlated with PETCT which will serve as the reference standard. | within 30 days of first treatment | |
Primary | Accuracy of VNC DECT | Will be measured using nonparametric estimates of the area under the receiver operating characteristic (ROC) curve using methods for clustered data (i.e. multiple locations per patient). ROC area estimates will be constructed for each reader for both SECT alone and DECT as an adjunct to SECT. For each reader, the ROC areas of SECT and DECT plus SECT will be compared using a Wald test; a significance level of 0.05 will be used. Analysis of variance methods for multiple-reader ROC studies will be used. A 95% confidence interval for the difference in ROC areas will be constructed. | within 30 days of first treatment |
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