Dual Energy CT (DECT)NCT03111914
Applications of Dual Energy CT in Patients With Osseous Metastases From Castrate-resistant Prostate Cancer
A study testing Dual Energy Computed Tomography in people with Dual Energy CT (DECT) and Prostate Cancer, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to establish a more accurate and precise way to image (take pictures of) metastatic bone disease in patients with prostate cancer for staging and monitoring response to therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Dual Energy CT (DECT), Prostate Cancer
- What is being tested?
- Dual Energy Computed Tomography
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2017to 9 Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Oncology patients with castrate-resistant prostate cancer planned for therapy with abiraterone acetate or enzalutamide and prednisolone undergoing clinically indicated MDCT (multi-detector computed tomography) of the chest, abdomen and pelvis
- > 18 years old
- Serum creatinine < 2.0
- BMI < 35kg/m^2
- Sign informed consent
Who cannot join
- History of anaphylactoid reaction to iodinated contrast material
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital
Durham, North Carolina, 27710
About this study
Official title: Applications of Dual Energy CT for Improving Staging and Monitoring of Therapy Response in Patients With Osseous Metastases From Castrate-resistant Prostate Cancer
The purpose of this study is to establish a more accurate and precise way to image (take pictures of) metastatic bone disease in patients with prostate cancer for staging and monitoring response to therapy. More specifically, the study aims to evaluate the capabilities of dual energy CT as a more precise and accurate tool for staging and monitoring of therapy response in patients with osseous metastases from castrate-resistant prostate cancer.
Bone metastases in prostate cancer patients are a clinical and diagnostic challenge to image. Sometimes very small metastatic bone lesions may only become detectable by imaging in response to therapy due to increased bone deposition during the first three months after therapy. Commonly used imaging tests (such as regular CT or bone scan) are unable to reliably tell the difference between increased bone deposition (therapy response) and growth of the lesion (progressive disease). This diagnostic challenge may have profound negative effects on patient management since it may require additional imaging before an accurate determination of tumor response can be made. An appropriate determination of tumor response is needed for appropriate management of prostate cancer. The investigators anticipate that the new imaging tested in this study (called dual energy CT) may provide additional critical information in this clinical and diagnostic challenge.
Approximately 100 people with prostate cancer and metastatic bone disease will take part in this study. At enrollment, three months, and six months, they will will receive a non-enhanced (without contrast) dual energy CT scan of the chest, abdomen and pelvis before receiving their routine, clinical contrast-enhanced CT scan.
- Conditions
- Dual Energy CT (DECT), Prostate Cancer
- Being tested
- Dual Energy Computed Tomography
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Energy Computed TomographyDiagnostic test
Also called DECT
The subject's diagnostic scan will be preceded by a not clinically indicated non enhanced dual energy scan. The overall radiation dose to the patient for the first and second acquisition will be twice the radiation dose of a conventional CT of the chest, abdomen and pelvis. The non enhanced dual energy scan will be repeated during a clinical follow-up after the subject's first three months of enrollment and at a clinical follow-up after six months of enrollment.
The clinically-indicated, contrast-enhanced diagnostic scan will be performed according to standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Dual Energy Computed Tomography (DECT) | Other | This is a single-arm study. Each patient will receive an unenhanced dual energy CT scan followed by a contrast-enhanced scan as part of clinical routine work up. No change in the contrast material injection protocol will be performed for this this study. Receives: Diagnostic Test: Dual Energy Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal Threshold for Iodine Uptake to Differentiate Between Therapy Response and Progression of Metastatic Bone Disease
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Measured: Duration of CT scan (approximately 5 minutes)
Sensitivity of Optimal Threshold for Iodine Uptake to Differentiate Between Therapy Response and Progression of Metastatic Bone Disease
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Measured: Duration of CT scan (approximately 5 minutes)
Specificity of Optimal Threshold for Iodine Uptake to Differentiate Between Therapy Response and Progression of Metastatic Bone Disease
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Measured: Duration of CT scan (approximately 5 minutes)
Accuracy of Optimal Threshold for Iodine Uptake to Differentiate Between Therapy Response and Progression of Metastatic Bone Disease
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Measured: Duration of CT scan (approximately 5 minutes)
Reader Performance for Iodine Maps and Fused Images to Differentiate Between Therapy Response and Progression of Metastatic Bone Disease
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Measured: Duration of CT scan (approximately 5 minutes)
Sensitivity of Imaging Approach
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Measured: Duration of CT scan (approximately 5 minutes)
Specificity of Imaging Approach
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Measured: Duration of CT scan (approximately 5 minutes)
Accuracy of Imaging Approach
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Measured: Duration of CT scan (approximately 5 minutes)
Secondary outcomes (9)
Optimal Threshold for Iodine Uptake to Diagnose of Metastatic Bone Disease.
To analyze the feasibility to detect bone metastasis at baseline more accurately, unenhanced bone marrow imaging will be calculated and additional dual energy based, calcium corrected iodine maps will be used to determine a threshold for detection of vital bone metastasis in order to calculate color coded bone maps for risk of presence of bone metastases.
Measured: Duration of CT scan (approximately 5 minutes)
Reader Performance for Iodine Maps and Fused Images to Diagnose Metastatic Bone Disease
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Measured: Duration of CT scan (approximately 5 minutes)
Sensitivity of Optimal Threshold for Iodine Uptake to Diagnose of Metastatic Bone Disease
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Measured: Duration of CT scan (approximately 5 minutes)
Specificity of Optimal Threshold for Iodine Uptake to Diagnose of Metastatic Bone Disease
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Measured: Duration of CT scan (approximately 5 minutes)
Accuracy of Optimal Threshold for Iodine Uptake to Diagnose of Metastatic Bone Disease
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Measured: Duration of CT scan (approximately 5 minutes)
Optimal Threshold for Iodine Uptake to Diagnose Metastatic Lymph Nodes
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Measured: Duration of CT scan (approximately 5 minutes)
Sensitivity of Optimal Threshold for Iodine Uptake to Diagnose Metastatic Lymph Nodes
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Measured: Duration of CT scan (approximately 5 minutes)
Specificity of Optimal Threshold for Iodine Uptake to Diagnose Metastatic Lymph Nodes
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Measured: Duration of CT scan (approximately 5 minutes)
Accuracy of Optimal Threshold for Iodine Uptake to Diagnose Metastatic Lymph Nodes
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Measured: Duration of CT scan (approximately 5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start3 Jul 2017
- Primary completion9 Oct 2017
- Study completion9 Oct 2017
Why it stopped: Budgetary Issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dual Energy CT (DECT)Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Medical Solutions
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111914
- Sponsor's protocol ID
- Pro00078046
- Status last verified
- Jan 2023
- First submitted
- 7 Apr 2017
- Last updated
- 20 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applications of Dual Energy CT for Improving Staging and Monitoring of Therapy Response in Patients With Osseous Metastases From Castrate-resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT03111914
- Acronym / sponsor ID
- Pro00078046
- Conditions
- Dual Energy CT (DECT), Prostate Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Budgetary Issues
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Siemens Medical Solutions
- Study start
- 3 Jul 2017 (actual)
- Primary completion
- 9 Oct 2017 (actual)
- Study completion
- 9 Oct 2017 (actual)
- First posted
- 13 Apr 2017 (actual)
- Results
- Posted 20 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to establish a more accurate and precise way to image (take pictures of) metastatic bone disease in patients with prostate cancer for staging and monitoring response to therapy. More specifically, the study aims to evaluate the capabilities of dual energy CT as a more precise and accurate tool for staging and monitoring of therapy response in patients with osseous metastases from castrate-resistant prostate cancer.
Bone metastases in prostate cancer patients are a clinical and diagnostic challenge to image. Sometimes very small metastatic bone lesions may only become detectable by imaging in response to therapy due to increased bone deposition during the first three months after therapy. Commonly used imaging tests (such as regular CT or bone scan) are unable to reliably tell the difference between increased bone deposition (therapy response) and growth of the lesion (progressive disease). This diagnostic challenge may have profound negative effects on patient management since it may require additional imaging before an accurate determination of tumor response can be made. An appropriate determination of tumor response is needed for appropriate management of prostate cancer. The investigators anticipate that the new imaging tested in this study (called dual energy CT) may provide additional critical information in this clinical and diagnostic challenge.
Approximately 100 people with prostate cancer and metastatic bone disease will take part in this study. At enrollment, three months, and six months, they will will receive a non-enhanced (without contrast) dual energy CT scan of the chest, abdomen and pelvis before receiving their routine, clinical contrast-enhanced CT scan.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dual Energy Computed Tomography (DECT) | Other | Diagnostic Test: Dual Energy Computed TomographyThis is a single-arm study. Each patient will receive an unenhanced dual energy CT scan followed by a contrast-enhanced scan as part of clinical routine work up. No change in the contrast material injection protocol will be performed for this this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Oncology patients with castrate-resistant prostate cancer planned for therapy with abiraterone acetate or enzalutamide and prednisolone undergoing clinically indicated MDCT (multi-detector computed tomography) of the chest, abdomen and pelvis
- > 18 years old
- Serum creatinine < 2.0
- BMI < 35kg/m^2
- Sign informed consent
Key exclusion criteria (1 listed)
- History of anaphylactoid reaction to iodinated contrast material
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 |
|---|---|---|
| Dual Energy Computed TomographyAlso: DECTThe subject's diagnostic scan will be preceded by a not clinically indicated non enhanced dual energy scan. The overall radiation dose to the patient for the first and second acquisition will be twice the radiation dose of a conventional CT of the chest, abdomen and pelvis. The non enhanced dual energy scan will be repeated during a clinical follow-up after the subject's first three months of enrollment and at a clinical follow-up after six months of enrollment. The clinically-indicated, contrast-enhanced diagnostic scan will be performed according to standard of care. | Diagnostic test | Dual Energy Computed Tomography (DECT) |
Primary outcome
Optimal Threshold for Iodine Uptake to Differentiate Between Therapy Response and Progression of Metastatic Bone Disease
Time frame: Duration of CT scan (approximately 5 minutes)
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Sensitivity of Optimal Threshold for Iodine Uptake to Differentiate Between Therapy Response and Progression of Metastatic Bone Disease
Time frame: Duration of CT scan (approximately 5 minutes)
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Specificity of Optimal Threshold for Iodine Uptake to Differentiate Between Therapy Response and Progression of Metastatic Bone Disease
Time frame: Duration of CT scan (approximately 5 minutes)
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Accuracy of Optimal Threshold for Iodine Uptake to Differentiate Between Therapy Response and Progression of Metastatic Bone Disease
Time frame: Duration of CT scan (approximately 5 minutes)
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Reader Performance for Iodine Maps and Fused Images to Differentiate Between Therapy Response and Progression of Metastatic Bone Disease
Time frame: Duration of CT scan (approximately 5 minutes)
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Sensitivity of Imaging Approach
Time frame: Duration of CT scan (approximately 5 minutes)
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Specificity of Imaging Approach
Time frame: Duration of CT scan (approximately 5 minutes)
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Accuracy of Imaging Approach
Time frame: Duration of CT scan (approximately 5 minutes)
Feasibility of monitoring metastatic bone disease in prostate cancer patients
9 secondary outcomes
Optimal Threshold for Iodine Uptake to Diagnose of Metastatic Bone Disease.
Time frame: Duration of CT scan (approximately 5 minutes)
Reader Performance for Iodine Maps and Fused Images to Diagnose Metastatic Bone Disease
Time frame: Duration of CT scan (approximately 5 minutes)
Sensitivity of Optimal Threshold for Iodine Uptake to Diagnose of Metastatic Bone Disease
Time frame: Duration of CT scan (approximately 5 minutes)
Specificity of Optimal Threshold for Iodine Uptake to Diagnose of Metastatic Bone Disease
Time frame: Duration of CT scan (approximately 5 minutes)
Accuracy of Optimal Threshold for Iodine Uptake to Diagnose of Metastatic Bone Disease
Time frame: Duration of CT scan (approximately 5 minutes)
Optimal Threshold for Iodine Uptake to Diagnose Metastatic Lymph Nodes
Time frame: Duration of CT scan (approximately 5 minutes)
Sensitivity of Optimal Threshold for Iodine Uptake to Diagnose Metastatic Lymph Nodes
Time frame: Duration of CT scan (approximately 5 minutes)
Specificity of Optimal Threshold for Iodine Uptake to Diagnose Metastatic Lymph Nodes
Time frame: Duration of CT scan (approximately 5 minutes)
Accuracy of Optimal Threshold for Iodine Uptake to Diagnose Metastatic Lymph Nodes
Time frame: Duration of CT scan (approximately 5 minutes)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual Energy Computed Tomography in people with Dual Energy CT (DECT) and Prostate Cancer, run by Duke University 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 5 inclusion and 1 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 20 Jan 2023. 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?
Yes. Results are posted in the registry (first posted 20 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Optimal Threshold for Iodine Uptake to Differentiate Between Therapy Response and Progression of Metastatic Bone Disease (time frame: Duration of CT scan (approximately 5 minutes)). The study lists 8 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 20 Jan 2023.