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Trial record 6 of 37 for:    Chest CT Scan | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Brief Summary:
This is a study that will evaluate the utility of a scatter reduction technique in reducing dose and increasing the sensitivity of stationary digital chest tomosynthesis (s-DCT) in the detection of lung lesions.

Condition or disease Intervention/treatment Phase
Pulmonary Nodule, Solitary Pulmonary Nodule, Multiple Device: Scatter corrected s-DCT Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with known lung lesion(s)
  • Patients having undergone a chest CT
  • Patients 18 years of age and older
  • Patients able to provide informed consent

Exclusion Criteria:

  • Patients who may not fit on a 35 x 35 detector (BMI > 35)
  • Planned procedures or therapies during study (in between SOC scans and study scan on s-DCT) (biopsy or removal of lung lesion)
  • Any woman who is pregnant, has reason to believe she is pregnant, or is lactating

Information from the National Library of Medicine

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


Contacts
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Contact: Tyler Jobe, MS (984) 974-8157 tyler_jobe@med.unc.edu
Contact: Terry Hartman, MS,MPH (919) 966-4997 terry_hartman@med.unc.edu

Locations
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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    tyler_jobe@med.unc.edu   
Contact: Terry Hartman, MS,MPH    9199664997    terry_hartman@med.unc.edu   
Sub-Investigator: Yueh Lee, MD,PhD         
Principal Investigator: Ertan Pamuklar, MD         
Sub-Investigator: Patricia Rivera, MD         
Sub-Investigator: Donglin Zeng, PhD         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Ertan Pamuklar, MD UNC Hospitals

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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04076696     History of Changes
Other Study ID Numbers: LCCC1822
18-1144 ( Other Identifier: UNC IRB )
1R21CA216780-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 2, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Chest
Lung
Tomography
Scatter
Additional relevant MeSH terms:
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Multiple Pulmonary Nodules
Solitary Pulmonary Nodule
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases