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

NCT ID: NCT03111914

Last Updated: 2023-01-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-03
• Study Completion Date: 2017-10-09

Brief 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. 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Dual Energy Computed Tomography

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

DECT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Siemens Medical Solutions

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke University Hospital

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00078046

Identifier Type: -

Identifier Source: org_study_id