Clinical Evaluation of Primary Sampling Scatter Correction for Chest Tomosynthesis
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|ClinicalTrials.gov Identifier: NCT04076696|
Recruitment Status : Not yet recruiting
First Posted : September 2, 2019
Last Update Posted : November 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Nodule, Solitary Pulmonary Nodule, Multiple||Device: Scatter corrected s-DCT||Not Applicable|
Digital tomosynthesis is an imaging modality that produces 3D sectional information using x-ray projections acquired over a limited scanning angle. Scatter is known to be the primary source of image degradation in x-ray based imaging.
The investigators have developed an approach that measures scatter through a low dose (3% of the conventional scan) scatter measurement technique. Preliminary studies have shown that scatter reduction in DCT can significantly improve quality. The approach will characterize the reader confidence in lung nodule detection in a scatter corrected chest tomosynthesis imaging approach as compared to the conventional chest tomosynthesis.
Fifty (50) patients who have undergone a clinical non-contrast CT with lung nodules will be asked to have an s-DCT (scan) within 4 weeks (+/- 2 week) of their clinical CT with no intervening procedures or therapies (i.e. biopsy of lung nodules). Investigators will then perform a reader study to evaluate the radiologist reader confidence in images generated from the scatter reduction technique versus more conventional chest tomosynthesis imaging.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Evaluation of Primary Sampling Scatter Correction for Chest Tomosynthesis|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
Experimental: Scatter corrected s-DCT
The study scan, s-DCT and correction scan, will be performed within two weeks of the patient's clinical evaluations by chest CT and x-ray. The study scan may be done within 2 weeks prior or two weeks following standard of care imaging. There cannot be any intervening therapies or procedures (i.e. biopsy or excision of lesions) done in between the standard of care (SOC) imaging and the s-DCT. All patients will have a breath held s-DCT scan in an anterior-posterior direction.
Device: Scatter corrected s-DCT
All patients will have a breath held s-DCT scan in an anterior-posterior direction
- Reader confidence in s-DCT images (arbitrary units) [ Time Frame: Baseline ]Readers will rate their confidence in images from one experimental modality as compared to the other on a 5 point scale (1 to 5) based on ability to identify lesion(s) present.
- Sensitivity of s-DCT images (percentage of positive scans) [ Time Frame: Baseline ]Sensitivity will be defined as the ability of s-DCT images to detect lesions positively identified on gold standard CT images.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04076696
|Contact: Tyler Jobe, MS||(984) email@example.com|
|Contact: Terry Hartman, MS,MPH||(919) firstname.lastname@example.org|
|United States, North Carolina|
|University of North Carolina at Chapel Hill||Not yet recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Tyler Jobe, MS 984-974-8157 email@example.com|
|Contact: Terry Hartman, MS,MPH 9199664997 firstname.lastname@example.org|
|Sub-Investigator: Yueh Lee, MD,PhD|
|Principal Investigator: Ertan Pamuklar, MD|
|Sub-Investigator: Patricia Rivera, MD|
|Sub-Investigator: Donglin Zeng, PhD|
|Principal Investigator:||Ertan Pamuklar, MD||UNC Hospitals|