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

NCT03111914 | Terminated Results FDA Device

• 1 other identifier: Pro00078046
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (8)

• 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

  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

  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

  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

  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

  Duration of CT scan (approximately 5 minutes)

• Sensitivity of Imaging Approach

  Feasibility of monitoring metastatic bone disease in prostate cancer patients

  Duration of CT scan (approximately 5 minutes)

• Specificity of Imaging Approach

  Feasibility of monitoring metastatic bone disease in prostate cancer patients

  Duration of CT scan (approximately 5 minutes)

• Accuracy of Imaging Approach

  Feasibility of monitoring metastatic bone disease in prostate cancer patients

  Duration of CT scan (approximately 5 minutes)

Secondary Outcomes (9)

• Optimal Threshold for Iodine Uptake to Diagnose of Metastatic Bone Disease.

  Duration of CT scan (approximately 5 minutes)

• Reader Performance for Iodine Maps and Fused Images to Diagnose Metastatic Bone Disease

  Duration of CT scan (approximately 5 minutes)

• Sensitivity of Optimal Threshold for Iodine Uptake to Diagnose of Metastatic Bone Disease

  Duration of CT scan (approximately 5 minutes)

• Specificity of Optimal Threshold for Iodine Uptake to Diagnose of Metastatic Bone Disease

  Duration of CT scan (approximately 5 minutes)

• Accuracy of Optimal Threshold for Iodine Uptake to Diagnose of Metastatic Bone Disease

  Duration of CT scan (approximately 5 minutes)

Study Arms (1)

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.

Diagnostic Test: Dual Energy Computed Tomography

Interventions

Dual Energy Computed Tomography 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.

Also known as: DECT

Dual Energy Computed Tomography (DECT)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- History of anaphylactoid reaction to iodinated contrast material

Sponsors & Collaborators

• Duke University: lead
• Siemens Medical Solutions: collaborator

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Limitations and Caveats

Due to the complexity and challenges in spatial resolution of clinical CT images, the intended analysis failed to differentiate between normal and abnormal bone marrow changes which precluded an accurate analysis of treatment effects. A consensus decision was made to stop recruitment until technical challenges have been solved.

Results Point of Contact

• Title: Dr. Daniele Marin
• Organization: Duke University

daniele.marin@duke.edu

919-684-7366

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 13, 2017
• Study Start: July 3, 2017
• Primary Completion: October 9, 2017
• Study Completion: October 9, 2017
• Last Updated: January 20, 2023
• Results First Posted: January 20, 2023

Record last verified: 2023-01

Locations

US (1)