Cleveland, Ohio 44106


Purpose:

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.


Study summary:

PRIMARY OBJECTIVES: 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.


Criteria:

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


NCT ID:

NCT02354326


Primary Contact:

Principal Investigator
Naveen Subhas, MD
Case Comprehensive Cancer Center

Naveen Subhas, MD
Phone: 216-445-9464
Email: subhasn@ccf.org


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44106
United States

Naveen Subhas, MD
Phone: 216-445-9464
Email: subhasn@ccf.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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