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Terminated due to slow enrollment.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Split CT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual-source multi-detector computed tomography (DSSE) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Image Noise | Up to 5 minutes |
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Inclusion Criteria:
-
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniele Marin | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Split CT | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subjects who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Split CT | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Image Noise | Data not collected. | Posted | Up to 5 minutes |
|
|
6 months
The patients were at very low risk for serious adverse events, mortality, or any other adverse event due to the different methodology used to deliver the same radiation dose the patient would have received in a standard abdomen and pelvis CT.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose Split CT | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniele Marin | Duke University Medical Center | 919-684-2711 | daniele.marin@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 5, 2018 | Nov 5, 2019 | Prot_SAP_000.pdf |
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|
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
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