Clinical Evaluation of Primary Sampling Scatter Correction for Chest Tomosynthesis

UNC Lineberger Comprehensive Cancer Center

Status: Completed

Conditions: Pulmonary Nodule, Multiple; Pulmonary Nodule, Solitary

Treatments: Device: Scatter corrected s-DCT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04076696

1R21CA216780-01A1 (U.S. NIH Grant/Contract)

18-1144 (Other Identifier)

LCCC1822

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Scatter corrected s-DCT

Experimental 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.

Treatment:

Device: Scatter corrected s-DCT