Malignant NeoplasmNCT02354326
Dual Energy Computed Tomography (CT) in Finding Bone Metastases in Patients With Cancer
An observational study of Malignant Neoplasm and Metastatic Malignant Neoplasm to the Bone, run by Case Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm, Metastatic Malignant Neoplasm to the Bone
- What is being tested?
- virtual non-calcium dual-energy computed tomography and computed tomography
- Type of treatment
- Surgery or procedure
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2014to 27 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patients obtaining a Positron Emission Tomography (PET) CT and a separate diagnostic CT scan as part of their routine clinical care
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: Evaluation of Bone Metastases With Dual Energy Computed Tomography (CT)
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Being tested
- virtual non-calcium dual-energy computed tomography, computed tomography
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual non-calcium dual-energy computed tomographyRadiation
Also called VNC DECT
Undergo VNC DECT
computed tomographyRadiation
Also called CT
Undergo CT without VNC
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: virtual non-calcium dual-energy computed tomography; Radiation: computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Lesions Present
Number of lesions detected at the 46 designated locations at the time of the VNC DECT
Measured: 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
Measured: 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.
Measured: 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.
Measured: within 30 days of first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study start7 Nov 2014
- Primary completion27 Sep 2017
- Study completion27 Sep 2017
Why it stopped: No bone lesions detected and poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Naveen Subhas, MD, Principal investigator, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354326
- Sponsor's protocol ID
- CASE5Y14
- Other IDs
- NCI-2014-02497, CASE5Y14, P30CA043703
- Status last verified
- Feb 2019
- First submitted
- 28 Jan 2015
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bone Metastases With Dual Energy Computed Tomography (CT)
- ClinicalTrials.gov ID
- NCT02354326
- Acronym / sponsor ID
- CASE5Y14
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No bone lesions detected and poor accrual
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Nov 2014 (actual)
- Primary completion
- 27 Sep 2017 (actual)
- Study completion
- 27 Sep 2017 (actual)
- First posted
- 3 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (VNC DECT) | – | Radiation: virtual non-calcium dual-energy computed tomography, Radiation: computed tomographyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients obtaining a Positron Emission Tomography (PET) CT and a separate diagnostic CT scan as part of their routine clinical care
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual non-calcium dual-energy computed tomographyAlso: VNC DECTUndergo VNC DECT | Radiation | Diagnostic (VNC DECT) |
| computed tomographyAlso: CTUndergo CT without VNC | Radiation | Diagnostic (VNC DECT) |
Primary outcome
Number of Lesions Present
Time frame: within 30 days of first treatment
Number of lesions detected at the 46 designated locations at the time of the VNC DECT
Number of lesions absent
Time frame: within 30 days of first treatment
Number of absent lesions from the 46 designated locations at the time of the VNC DECT
Confidence in the presence of one or more lesions in that particular anatomic location using a 0-100 point confidence scale
Time frame: within 30 days of first treatment
Each location will be correlated with PETCT which will serve as the reference standard.
Accuracy of VNC DECT
Time frame: within 30 days of first treatment
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.
Results and safety
The study was stopped early (reason given: No bone lesions detected and poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naveen Subhas, MD principal investigator
Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Neoplasm and Metastatic Malignant Neoplasm to the Bone, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No bone lesions detected and poor accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Lesions Present (time frame: within 30 days of first treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.