Clinical Evaluation of Primary Sampling Scatter Correction for Chest Tomosynthesis

• Sponsor: UNC Lineberger Comprehensive Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04076696
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 38
• Location: 1
• Arm: 1
• Actual Duration (Months): 12
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Clinical Evaluation of Primary Sampling Scatter Correction for Chest Tomosynthesis
• Actual Study Start Date: Aug 26, 2020
• Actual Primary Completion Date: Aug 26, 2021
• Actual Study Completion Date: Aug 26, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Reader Confidence in s-DCT Images Compared to Conventional CT (Units on a Scale) [Baseline]

   Readers will rate their confidence in images from the experimental modality (sDCT with scatter correction) as compared to the conventional scan (chest CT with x-ray) on a 7 point Likert scale (-3 to 3) based on ability to identify lesion(s) present comparing each modality. A value of -3 is significantly less confident in the s-DCT representation 0 is the same confidence in modalities, and 3 is significantly more confident in the s-DCT representation compared to the conventional. Each individual will have a single value per reader. Two readers compared each scan. The overall reader preference between modalities was calculated by determining the mean value.

Secondary Outcome Measures

1. Sensitivity of s-DCT Images (Percentage of Positive Scans) [Baseline]

   Sensitivity will be defined as the ability of s-DCT images to detect lesions positively identified on gold standard CT images.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599

Sponsors and Collaborators

• UNC Lineberger Comprehensive Cancer Center
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Ertan Pamuklar, MD, UNC Hospitals

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 12, 2021

More Information

Publications

None provided.

• Responsible Party: UNC Lineberger Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT04076696
• Other Study ID Numbers: LCCC1822; 18-1144; 1R21CA216780-01A1
• First Posted: Sep 3, 2019
• Last Update Posted: Aug 8, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Keywords provided by UNC Lineberger Comprehensive Cancer Center: Chest; Lung; Tomography; Scatter
• Additional relevant MeSH terms: Multiple Pulmonary Nodules; Solitary Pulmonary Nodule

Study Results

Participant Flow

Arm/Group Title	Scatter Corrected s-DCT
Arm/Group Description	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. Scatter corrected s-DCT: All patients will have a breath held s-DCT scan in an anterior-posterior direction
Period Title: Overall Study
STARTED	38
COMPLETED	38
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Scatter Corrected s-DCT
Arm/Group Description	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. Scatter corrected s-DCT: All patients will have a breath held s-DCT scan in an anterior-posterior direction
Overall Participants	38
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64 (17)
Sex: Female, Male (Count of Participants)
Female	22 57.9%
Male	16 42.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 2.6%
Not Hispanic or Latino	36 94.7%
Unknown or Not Reported	1 2.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	3 7.9%
White	32 84.2%
More than one race	0 0%
Unknown or Not Reported	3 7.9%
Region of Enrollment (Count of Participants)
United States	38 100%

Outcome Measures

1. Primary Outcome

Title	Reader Confidence in s-DCT Images Compared to Conventional CT (Units on a Scale)
Description	Readers will rate their confidence in images from the experimental modality (sDCT with scatter correction) as compared to the conventional scan (chest CT with x-ray) on a 7 point Likert scale (-3 to 3) based on ability to identify lesion(s) present comparing each modality. A value of -3 is significantly less confident in the s-DCT representation 0 is the same confidence in modalities, and 3 is significantly more confident in the s-DCT representation compared to the conventional. Each individual will have a single value per reader. Two readers compared each scan. The overall reader preference between modalities was calculated by determining the mean value.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Scatter Corrected s-DCT
Arm/Group Description	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. Scatter corrected s-DCT: All patients will have a breath held s-DCT scan in an anterior-posterior direction
Measure Participants	38
Mean (Standard Deviation) [Units on a scale]	-0.43 (0.62)

2. Secondary Outcome

Title	Sensitivity of s-DCT Images (Percentage of Positive Scans)
Description	Sensitivity will be defined as the ability of s-DCT images to detect lesions positively identified on gold standard CT images.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Scatter Corrected s-DCT
Arm/Group Description	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. Scatter corrected s-DCT: All patients will have a breath held s-DCT scan in an anterior-posterior direction
Measure Participants	38
Number (95% Confidence Interval) [percentage of positive scans]	0.407

Adverse Events

Time Frame	Adverse events occurring during the participants' participation in the study visit were collected directly following imaging for 30 minutes post imaging.
Arm/Group Title	Scatter Corrected s-DCT
Arm/Group Description	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. Scatter corrected s-DCT: All patients will have a breath held s-DCT scan in an anterior-posterior direction
All Cause Mortality
	Scatter Corrected s-DCT
	Affected / at Risk (%)	# Events
Total	0/38 (0%)
Serious Adverse Events
	Scatter Corrected s-DCT
	Affected / at Risk (%)	# Events
Total	0/38 (0%)
Other (Not Including Serious) Adverse Events
	Scatter Corrected s-DCT
	Affected / at Risk (%)	# Events
Total	0/38 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.