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

Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02354326
• Other study ID #: CASE5Y14
• Secondary ID: NCI-2014-02497CA
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Neoplasms
• Malignant Neoplasm
• Metastatic Malignant Neoplasm to the Bone
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary

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