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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02354326
Other study ID # CASE5Y14
Secondary ID NCI-2014-02497CA
Status Terminated
Phase
First received
Last updated
Start date November 7, 2014
Est. completion date September 27, 2017

Study information

Verified date February 2019
Source Case Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
virtual non-calcium dual-energy computed tomography
Undergo VNC DECT
computed tomography
Undergo CT without VNC

Locations

Country Name City State
United States Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Cleveland Ohio

Sponsors (2)

Lead Sponsor Collaborator
Case Comprehensive Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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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