Clinical trial NCT02354326: 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)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Malignant Neoplasm
Metastatic Malignant Neoplasm to the Bone
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-02-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients obtaining a Positron Emission Tomography (PET) CT and a separate diagnostic CT scan as part of their routine clinical care

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Number of Lesions Present
timeFrame: within 30 days of first treatment
measure: Number of lesions absent
timeFrame: within 30 days of first treatment
measure: Confidence in the presence of one or more lesions in that particular anatomic location using a 0-100 point confidence scale
timeFrame: within 30 days of first treatment
measure: Accuracy of VNC DECT
timeFrame: within 30 days of first treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Naveen Subhas, MD
role: PRINCIPAL_INVESTIGATOR
References: