Patient- and Task-specific Radiation Dose Optimization for Pediatric Abdominopelvic CT Applications

Radiation dose reduction has been a primary driver of technology development in multi-detector computed tomography (MDCT). The optimization of radiation dose for patient and task specific computed tomography (CT) applications continues to be an ongoing challenge, especially in pediatric patients where the desire to reduce radiation dose to lowest possible levels leads to both positive and negative effects. A novel research tool on the Siemens dual source (Flash® and Force ®) CT scanners allows one to assess multiple tube current levels from a single CT acquisition without incurring additional dose to the patient. Tube current is a primary contributor to radiation dose and image noise, which are inversely related. This is achieved by independently adjusting the current of each tube, while maintaining same kV in each x-ray tube. Moreover, Duke's medical physics team has developed a method based on mathematical expressions that allows the creation of incremental dose levels from the acquired image data sets. This innovative and powerful tool can be used to compare diagnostic accuracy, detectability, and many more relevant clinical features amongst multiple tube current levels with the attainment of a single CT acquisition.

Study Overview

• Status: Terminated
• Conditions: Split Dose CT
• Intervention / Treatment: Device: Dual-source multi-detector computed tomography (DSSE)

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

-

Exclusion Criteria:

• Pregnant

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Split CT	Device: Dual-source multi-detector computed tomography (DSSE); Dose split technique in a cohort of pediatric patients to determine, without increase in patient radiation dose, the optimal patient-specific and task-specific radiation dose levels for pediatric cardiothoracic and abdominal CT applications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Image Noise	Up to 5 minutes

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Daniele Marin, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2018
• Primary Completion (Actual): April 12, 2019
• Study Completion (Actual): April 12, 2019

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: February 6, 2018
• First Posted (Actual): February 12, 2018

Study Record Updates

• Last Update Posted (Actual): November 27, 2019
• Last Update Submitted That Met QC Criteria: November 25, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: CT Scan
• Other Study ID Numbers: Pro00077173

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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