Expired Study
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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


Study is Available At:


Original ID:

CASE5Y14


NCT ID:

NCT02354326


Secondary ID:

NCI-2014-02497


Study Acronym:


Brief Title:

Dual Energy Computed Tomography (CT) in Finding Bone Metastases in Patients With Cancer


Official Title:

Evaluation of Bone Metastases With Dual Energy Computed Tomography (CT)


Overall Status:

Terminated


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Case Comprehensive Cancer Center


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

No bone lesions detected and poor accrual


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

16


Enrollment Type:

Actual


Overall Contact Information

Official Name:Naveen Subhas, MD
Principal Investigator
Case Comprehensive Cancer Center

Study Dates

Start Date:November 7, 2014
Completion Date:September 27, 2017
Completion Type:Actual
Primary Completion Date:September 27, 2017
Primary Completion Type:Actual
Verification Date:February 2019
Last Changed Date:February 1, 2019
First Received Date:January 28, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Accuracy of VNC DECT
Time Frame:within 30 days of first treatment
Safety Issues:False
Description: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
Outcome Type:Primary Outcome
Measure:Confidence in the presence of one or more lesions in that particular anatomic location using a 0-100 point confidence scale
Time Frame:within 30 days of first treatment
Safety Issues:False
Description:Each location will be correlated with PETCT which will serve as the reference standard.
Outcome Type:Primary Outcome
Measure:Number of lesions absent
Time Frame:within 30 days of first treatment
Safety Issues:False
Description:Number of absent lesions from the 46 designated locations at the time of the VNC DECT
Outcome Type:Primary Outcome
Measure:Number of Lesions Present
Time Frame:within 30 days of first treatment
Safety Issues:False
Description:Number of lesions detected at the 46 designated locations at the time of the VNC DECT

Study Interventions

Intervention Type:Radiation
Name:virtual non-calcium dual-energy computed tomograph
Description:Undergo VNC DECT
Arm Name:Diagnostic (VNC DECT)
Other Name:VNC DECT
Intervention Type:Radiation
Name:computed tomography
Description:Undergo CT without VNC
Arm Name:Diagnostic (VNC DECT)
Other Name:CT

Study Arms

Study Arm Type:Other
Arm Name:Diagnostic (VNC DECT)
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Case Comprehensive Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Samples and Retentions

Study Population: Cancer patients obtaining a Positron Emission Tomography (PET) CT and a separate diagnostic CT scan as part of their routine clinical care
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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