Clinical Evaluation of Primary Sampling Scatter Correction for Chest Tomosynthesis

NCT ID: NCT04076696

Last Updated: 2022-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-26
• Study Completion Date: 2021-08-26

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.

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.

Conditions

Pulmonary Nodule, Solitary; Pulmonary Nodule, Multiple

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Scatter corrected s-DCT

Intervention Type: DEVICE

All patients will have a breath held s-DCT scan in an anterior-posterior direction

Interventions

Scatter corrected s-DCT

All patients will have a breath held s-DCT scan in an anterior-posterior direction

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ertan Pamuklar, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Hospitals

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18-1144

Identifier Type: OTHER

Identifier Source: secondary_id

1R21CA216780-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

LCCC1822

Identifier Type: -

Identifier Source: org_study_id