NCT02354326

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 3, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2017

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

2.9 years

First QC Date

January 28, 2015

Last Update Submit

February 1, 2019

Conditions

Malignant NeoplasmMetastatic Malignant Neoplasm to the Bone

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

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.

Radiation: virtual non-calcium dual-energy computed tomographyRadiation: computed tomography

Interventions

virtual non-calcium dual-energy computed tomographyRADIATION

Undergo VNC DECT

Also known as: VNC DECT
Diagnostic (VNC DECT)
computed tomographyRADIATION

Undergo CT without VNC

Also known as: CT
Diagnostic (VNC DECT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Naveen Subhas, MD

    Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2015

First Posted

February 3, 2015

Study Start

November 7, 2014

Primary Completion

September 27, 2017

Study Completion

September 27, 2017

Last Updated

February 5, 2019

Record last verified: 2019-02

Locations

US(1)