Trial Outcomes & Findings for Evaluation of the Lung Nodule Sensitivity of Stationary Chest Tomosynthesis in Patients With Known Lung Nodules (NCT NCT02075320)

NCT ID: NCT02075320

Last Updated: 2022-05-18

Results Overview

Sensitivity for our study is defined as the ability of s-DCT to detect a lung lesion known to exist based on non-contrast CT (the gold standard) for any sized lung nodule.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

1 year following imaging

Results posted on

2022-05-18

Participant Flow

Participant milestones

Participant milestones
Measure	Stationary Digital Chest Tomosynthesis All patients will be included in the experimental group. Stationary Digital Chest Tomosynthesis (s-DCT): The study scan, s-DCT, will be performed within two weeks of his/her clinical evaluations by chest computed tomography (CT) and chest radiograph (CR). 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. 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. Images will be acquired by a trained radiologist technologist. The technologist will comfortably position the patient in the supine position on the imaging table. Then, all patients will have a breath held s-DCT scan in an anterior-posterior direction.
Overall Study STARTED	50
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Stationary Digital Chest Tomosynthesis All patients will be included in the experimental group. Stationary Digital Chest Tomosynthesis (s-DCT): The study scan, s-DCT, will be performed within two weeks of his/her clinical evaluations by chest computed tomography (CT) and chest radiograph (CR). 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. 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. Images will be acquired by a trained radiologist technologist. The technologist will comfortably position the patient in the supine position on the imaging table. Then, all patients will have a breath held s-DCT scan in an anterior-posterior direction.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stationary Digital Chest Tomosynthesis n=48 Participants All patients will be included in the experimental group. Stationary Digital Chest Tomosynthesis: 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. Images will be acquired by a trained radiologist technologist. The technologist will comfortably position the patient in the supine position on the imaging table. Then, all patients will have a breath held s-DCT scan in an anterior-posterior direction.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	29 Participants n=5 Participants
Age, Continuous	64 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	39 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	48 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year following imaging

Sensitivity for our study is defined as the ability of s-DCT to detect a lung lesion known to exist based on non-contrast CT (the gold standard) for any sized lung nodule.

Outcome measures

Outcome measures
Measure	Stationary Digital Chest Tomosynthesis n=48 Participants All patients will be included in the experimental group. Stationary Digital Chest Tomosynthesis: 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. Images will be acquired by a trained radiologist technologist. The technologist will comfortably position the patient in the supine position on the imaging table. Then, all patients will have a breath held s-DCT scan in an anterior-posterior direction.
Sensitivity	53 percentage of positive scans

PRIMARY outcome

Timeframe: 1 year following imaging

Population: All subjects

Specificity for our study is defined as the ability of s-DCT to correctly identify the absence of a lung nodule as confirmed by CT (gold standard).

Outcome measures

Outcome measures
Measure	Stationary Digital Chest Tomosynthesis n=48 Participants All patients will be included in the experimental group. Stationary Digital Chest Tomosynthesis: 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. Images will be acquired by a trained radiologist technologist. The technologist will comfortably position the patient in the supine position on the imaging table. Then, all patients will have a breath held s-DCT scan in an anterior-posterior direction.
Specificity	26 percentage of negative scans

SECONDARY outcome

Timeframe: 1 year following imaging

Population: Insufficient numbers of patients had follow-up biopsies, imaging, or follow-up. Ratio could not be calculated as the denominator is 0.

Specificity for this objective is defined as the ability of the s-DCT system to identify a lesion as non-malignant over the course of 1 year post s-DCT. The gold standard will vary depending on the clinical situation as follows: * In the subset of who undergo a biopsy of a suspicious lesion, the pathology report will be the gold standard. * If a biopsy is not performed, but CT scan is performed within the 1 year timeframe, and a diagnosis of malignancy based on this nodule is made, the CT scan will be the gold standard. * If a biopsy or CT scan is not performed, but the clinical records indicate the lesion is malignant (within the one year timeframe), this will be the gold standard.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year following imaging

To evaluate radiologists confidence in evaluating lung nodules of all sizes comparing s-DCT to CT. Readers will be scored using a 7 point Likert scale from -3 to +3. Negative scores in favor of CT and positive scores more in favor of s-DCT. Readers rated images based on shape/morphology, calcifications, and architectural distortion

Outcome measures

Outcome measures
Measure	Stationary Digital Chest Tomosynthesis n=48 Participants All patients will be included in the experimental group. Stationary Digital Chest Tomosynthesis: 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. Images will be acquired by a trained radiologist technologist. The technologist will comfortably position the patient in the supine position on the imaging table. Then, all patients will have a breath held s-DCT scan in an anterior-posterior direction.
Reader Preference	-2.2 units on a scale Standard Deviation 0.5

Adverse Events

Stationary Digital Chest Tomosynthesis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Yueh Lee

UNC School of Medicine Department of Radiology

Phone: (919) 537-3730

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place