Evaluation of the Lung Nodule Sensitivity of Stationary Chest Tomosynthesis Versus Chest Radiographs in Patients With Known Lung Nodules

This is a one arm study of 100 patients with one or more lung nodules based on standard imaging (chest CT) at UNC Hospitals that consent to undergo an experimental s-DCT to characterize the number and extent of lung nodules. Most patients will also have undergone a standard of care (SOC) chest radiograph (CR). The sensitivity of the CR and of the experimental s-DCT will be estimated separately, using the CT as the gold-standard. The sensitivities of the CR and the s-DCT will then be compared. In the event that CRs are not included in the SOC imaging or are unusable (outside of acceptable window (i.e. do not accommodate s-DCT within 2 weeks) or poor quality), the scout image acquired by CT will be used in place of a CR. The scout image is a preliminary radiograph that is taken prior to performing a definitive CT.

Working in collaboration with the University of North Carolina (UNC) Multi-Disciplinary Thoracic Oncology (MTOP) group, the investigators plan to inform patients that they may be contacted to participate in this study to evaluate the sensitivity of the s-DCT system, using the SOC CR and chest CT for comparison. CRs are included to provide a basis for comparing system sensitivity, representing a minimum standard.

Once a patient has been referred, or the investigators have collaborated with the treating clinic regarding the eligibility of a subject, the patient will be approached by a coordinator from Radiology to assess interest in participation. The coordinator will either go to the treating clinic, or will call the patient at home, after he/she have been apprised of the study by his/her treating physician/nurse.

If the patient is interested in participation, he/she will be consented either then (in their treatment clinic) or when he/she arrives to have his/her s-DCT, but prior to any study procedures. Review of the consent will take place in the privacy of an exam room, or when possible, a sample consent form will be sent to the patient via email prior to arriving for the scan to allow for ample review. Once the patient has consented, women of child bearing potential (WCBP) will be given a urine pregnancy test in order to ensure that they are not pregnant. If a urine pregnancy test shows a result positive for pregnancy, the patient will be excluded from the study per the exclusion criteria because the investigators cannot, in good conscience, expose a fetus to unnecessary radiation exposure. If the urine pregnancy test shows that the patient is not pregnant, she may participate in the study.

The study scan, s-DCT, will be performed within two weeks of his/her clinical evaluations by chest CT and CR. There cannot be any intervening therapies or procedures (i.e. biopsy or excision of lesions) done in between the SOC imaging and the s-DCT. In the event that CRs are not included in the SOC imaging or are unusable (outside of acceptable window or poor quality), the scout image acquired by CT will be used in place of a CR.