Pulmonary Nodule, Multiple, Pulmonary Nodule, Solitary
Conditions
Keywords
Chest, Lung, Tomography, Scatter
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.
Interventions
DEVICEScatter corrected s-DCT
All patients will have a breath held s-DCT scan in an anterior-posterior direction
Sponsors
National Cancer Institute (NCI)
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Scatter corrected s-DCT: All patients will have a breath held s-DCT scan in an anterior-posterior direction | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | Scatter Corrected s-DCT |
|---|---|
| Age, Continuous | 64 years STANDARD_DEVIATION 17 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 32 Participants |
| Region of Enrollment United States | 38 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 38 |
| other Total, other adverse events | 0 / 38 |
| serious Total, serious adverse events | 0 / 38 |
Outcome results
Primary
Reader Confidence in s-DCT Images Compared to Conventional CT (Units on a Scale)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Scatter Corrected s-DCT | Reader Confidence in s-DCT Images Compared to Conventional CT (Units on a Scale) | -0.43 Units on a scale | Standard Deviation 0.62 |
Secondary
Sensitivity of s-DCT Images (Percentage of Positive Scans)
Sensitivity will be defined as the ability of s-DCT images to detect lesions positively identified on gold standard CT images.
Time frame: Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Scatter Corrected s-DCT | Sensitivity of s-DCT Images (Percentage of Positive Scans) | 0.407 percentage of positive scans |