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

NCT ID: NCT02354326

Last Updated: 2019-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-07

Study Completion Date

2017-09-27

Brief Summary

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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

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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.

Conditions

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Malignant Neoplasm Metastatic Malignant Neoplasm to the Bone

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Diagnostic (VNC DECT)

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.

virtual non-calcium dual-energy computed tomography

Intervention Type RADIATION

Undergo VNC DECT

computed tomography

Intervention Type RADIATION

Undergo CT without VNC

Interventions

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virtual non-calcium dual-energy computed tomography

Undergo VNC DECT

Intervention Type RADIATION

computed tomography

Undergo CT without VNC

Intervention Type RADIATION

Other Intervention Names

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VNC DECT CT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Naveen Subhas, MD

Role: PRINCIPAL_INVESTIGATOR

Case Comprehensive Cancer Center

Locations

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Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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NCI-2014-02497

Identifier Type: REGISTRY

Identifier Source: secondary_id

CASE5Y14

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CASE5Y14

Identifier Type: -

Identifier Source: org_study_id

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