Applications of Dual Energy CT in Patients With Osseous Metastases From Castrate-resistant Prostate Cancer

January 4, 2023 updated by: Duke University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. 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
  2. > 18 years old
  3. Serum creatinine < 2.0
  4. BMI < 35kg/m^2
  5. Sign informed consent

Exclusion Criteria:

- History of anaphylactoid reaction to iodinated contrast material

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Dual Energy Computed Tomography (DECT)
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.
Diagnostic test: Dual Energy Computed Tomography

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.

Other Names:
  • DECT

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: Duration of CT scan (approximately 5 minutes)
Feasibility of monitoring metastatic bone disease in prostate cancer patients
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
Time Frame: Duration of CT scan (approximately 5 minutes)
Feasibility of monitoring metastatic bone disease in prostate cancer patients
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
Time Frame: Duration of CT scan (approximately 5 minutes)
Feasibility of monitoring metastatic bone disease in prostate cancer patients
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
Time Frame: Duration of CT scan (approximately 5 minutes)
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Duration of CT scan (approximately 5 minutes)
Sensitivity of Imaging Approach
Time Frame: Duration of CT scan (approximately 5 minutes)
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Duration of CT scan (approximately 5 minutes)
Specificity of Imaging Approach
Time Frame: Duration of CT scan (approximately 5 minutes)
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Duration of CT scan (approximately 5 minutes)
Accuracy of Imaging Approach
Time Frame: Duration of CT scan (approximately 5 minutes)
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Duration of CT scan (approximately 5 minutes)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Optimal Threshold for Iodine Uptake to Diagnose of Metastatic Bone Disease.
Time Frame: Duration of CT scan (approximately 5 minutes)
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.
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)
Feasibility of monitoring metastatic bone disease in prostate cancer patients
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)
Feasibility of monitoring metastatic bone disease in prostate cancer patients
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)
Feasibility of monitoring metastatic bone disease in prostate cancer patients
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)
Feasibility of monitoring metastatic bone disease in prostate cancer patients
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)
Feasibility of monitoring metastatic bone disease in prostate cancer patients
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)
Feasibility of monitoring metastatic bone disease in prostate cancer patients
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)
Feasibility of monitoring metastatic bone disease in prostate cancer patients
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)
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Duration of CT scan (approximately 5 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Siemens Medical Solutions

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 3, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 9, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 9, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00078046

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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