title: A prospective radiological study of thin-section computed tomography to predict pathological noninvasiveness in peripheral clinical IA lung cancer (Japan Clinical Oncology Group 0201).
abstract: OBJECTIVE
  Pathological noninvasiveness needs to be precisely predicted in preoperative radiological examinations of patients with early lung cancer for the application of limited surgery.
  
  
  METHODS
  Patients with clinical T1N0M0 peripheral lung cancer were recruited. Radiological findings of the main tumor were evaluated as to ground-glass opacity with thin-section computed tomography. The primary end point was specificity, i.e., the proportion of patients with radiologically diagnosed invasive lung cancer to patients with pathologically diagnosed invasive lung cancer. The precision-based planned sample size was 450. We expected that the lower limit of the 95% confidence interval (CI) for specificity should be satisfied in ≥97% of patients.
  
  
  RESULTS
  We enrolled 811 patients from 31 institutions between December 2002 and May 2004. The primary end point was evaluated in 545 patients. The specificity and sensitivity for the diagnosis of pathologically diagnosed invasive cancer were 96.4% (161/167, 95% CI: 92.3-98.7%) and 30.4% (115/378, 95% CI: 25.8-35.3%), respectively, i.e., a negative result. Nevertheless, the specificity for lung adenocarcinoma ≤2.0 cm with ≤0.25 consolidation to the maximum tumor diameter was 98.7% (95% CI: 93.2-100.0%), and this criterion could be used to radiologically define early adenocarcinoma of the lung.
  
  
  CONCLUSIONS
  Although our predetermined criterion for specificity was not statistically confirmed, radiological diagnosis of noninvasive lung cancer with a thin-section computed tomography scan corresponded well with pathological invasiveness. Radiological noninvasive peripheral lung adenocarcinoma could be defined as an adenocarcinoma ≤2.0 cm with ≤0.25 consolidation.
authors.affiliation: Division of Thoracic Surgery, National Cancer Center Hospital, Tokyo, Japan. kjsuzuki@juntendo.ac.jp
authors.forename: Kenji
authors.initials: K
authors.lastname: Suzuki
authors.forename: Teruaki
authors.initials: T
authors.lastname: Koike
authors.forename: Takashi
authors.initials: T
authors.lastname: Asakawa
authors.forename: Masahiko
authors.initials: M
authors.lastname: Kusumoto
authors.forename: Hisao
authors.initials: H
authors.lastname: Asamura
authors.forename: Kanji
authors.initials: K
authors.lastname: Nagai
authors.forename: Hirohito
authors.initials: H
authors.lastname: Tada
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Mitsudomi
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tsuboi
authors.forename: Taro
authors.initials: T
authors.lastname: Shibata
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Fukuda
authors.forename: Harubumi
authors.initials: H
authors.lastname: Kato
mesh_terms: D000230:Adenocarcinoma / Q000000981:diagnostic imaging / Q000556:secondary* / Q000601:surgery; D000328:Adult; D000368:Aged; D018287:Carcinoma, Large Cell / Q000000981:diagnostic imaging / Q000556:secondary* / Q000601:surgery; D002294:Carcinoma, Squamous Cell / Q000000981:diagnostic imaging / Q000556:secondary* / Q000601:surgery; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology* / Q000601:surgery; D008207:Lymphatic Metastasis; D008297:Male; D008867:Microtomy; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D009364:Neoplasm Recurrence, Local / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery; D009367:Neoplasm Staging; D011379:Prognosis; D011446:Prospective Studies; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D014057:Tomography, X-Ray Computed; D055815:Young Adult