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Introduction: In 2003, the Department of Medical Imaging at the University Health Network in Toronto, Ontario, became the first Canadian site of the International Early Lung Cancer Action Program (I-ELCAP). We report the results from the first 1000 baseline studies. Methods: Between June 2003 and December 2005, we enrolled 1000 high-risk smokers (that is, smokers with a history of at least 10 pack years, or the equivalent of one pack daily for 10 years), aged 55 years or older. A low-dose helical computed tomography (CT) (40 to 60 mA, 120 kV) was performed with 1.0 to 1.25 mm collimation. Nodules found at baseline were followed according to the I-ELCAP protocol: 1) no noncalcified nodules (NCNs) or NCNs ≤ 4 mm or nonsolid nodules < 8 mm, annual repeat; 2) NCNs ≥ 5 mm or nonsolid nodules < 8 mm, 3-month follow-up; or 3) nonsolid nodules ≥ 15 mm, antibiotics and 1-month follow-up. Results: The first 1000 study participants were aged 63 years, standard deviation (SD) 6 years, with a smoking history of 38 pack years, SD 22 pack years; 662 (66%) were former smokers, and 338 (34%) were current smokers; 453 (45%) were men, and 547 (55%) were women. Of the participants, 256 (26%) had a positive baseline low-dose computed tomography (LDCT) scan; 227 (23%) were followed after 3 months and 16 (1.6%) after 1 month; 7 (0.7%) received a contrast-enhanced CT and 6 (0.6%) an immediate CT-guided biopsy. Twenty-six invasive procedures were performed: 22 CT-guided biopsies, 1 ultrasound-guided lymph node metastasis biopsy, 1 bronchoscopic biopsy, and 2 surgeries. The malignancy rate of the invasive procedures was 85%. Overall, the malignancy prevalence is 2.2%. Of the malignancies, 20 are lung carcinomas: 19 non-small-cell lung carcinomas (NSCLCs) (14 adenocarcinoma or bronchioalveolar carcinoma [BAC], 4 squamous carcinoma, and 1 large-cell carcinoma) and 1 small-cell carcinoma; 15 (78%) of the NSCLCs are Stage I. Fourteen patients underwent surgery (1 pneumonectomy, 9 lobectomies, and 4 segmentectomies). Conclusion: Our results confirm that LDCT identifies small, early-stage, resectable lung cancer in a high-risk population. [ABSTRACT FROM AUTHOR]

Despite the positive outcome of the recent randomized trial of computed tomography (CT) screening for lung cancer, substantial implementation challenges remain, including the clear reporting of relative risk and suggested workup of screen-detected nodules. Based on current literature, we propose a 6-level Lung-Reporting and Data System (LU-RADS) that classifies screening CTs by the nodule with the highest malignancy risk. As the LU-RADS level increases, the risk of malignancy increases. The LU-RADS level is linked directly to suggested follow-up pathways. Compared with current narrative reporting, this structure should improve communication with patients and clinicians, and provide a data collection framework to facilitate screening program evaluation and radiologist training. In overview, category 1 includes CTs with no nodules and returns the subject to routine screening. Category 2 scans harbor minimal risk, including <5 mm, perifissural, or long-term stable nodules that require no further workup before the next routine screening CT. Category 3 scans contain indeterminate nodules and require CT follow up with the interval dependent on nodule size (small [5-9 mm] or large [≥ 10 mm] and possibly transient). Category 4 scans are suspicious and are subdivided into 4A, low risk of malignancy; 4B, likely low-grade adenocarcinoma; and 4C, likely malignant. The 4B and 4C nodules have a high likelihood of neoplasm simply based on screening CT features, even if positron emission tomography, needle biopsy, and/or bronchoscopy are negative. Category 5 nodules demonstrate frankly malignant behavior on screening CT, and category 6 scans contain tissue-proven malignancies. [ABSTRACT FROM AUTHOR]