Clinical trial · Interventional
Lung Cancer Early Diagnosis With Digital Tomosynthesis: Re-evaluation of Lung Nodule Detection Rate at 5 Years
A Monocenter Prospective No-profit Interventional Study for Lung Cancer Early Diagnosis With Tomosynthesis: Re-evaluation of Lung Nodule Detection Rate at 5 Years
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Lung cancer is the leading cause of cancer-related death around the world, it represents 13% of all new cancer diagnoses. The lung cancer incidence is gradually increasing, especially among women and young people, but the fraction of cured patient remains low. In 80% of cases lung cancer, in early phase, is treatable only with surgery without chemotherapy or adjuvant radiotherapy and the survival perspective at five years exceeds 70%. Several scientific guidelines recommends chest CT (computed tomography) in lung cancer screening. Digital tomosynthesis (DTS) is a limited angle tomography that allows reconstruction of coronal images from a set of projection acquired over a small angle of X-ray tube movement. Several studies demonstrates that DTS is a reasonable alternative to the CT and allows a better evaluation of suspects nodules compared to conventional chest RX.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| diagnosis with tomosynthesis | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- diagnosis with tomosynthesis (DTS)
- description
- Single arm. Population: Subjects enrolled in previously closed SOS trial (high risk subjects for lung cancer) without confirmed lung cancer.
- interventionNames
- Diagnostic Test: diagnosis with tomosynthesis
Primary outcomes (1)
- measure
- To evaluate the lung cancer detection rate in the population of high risks subjects previously enrolled in lung cancer screening trial with chest digital tomosynthesis (SOS trial).
- timeFrame
- 1 year
- description
- Lung cancer detection rate (primary endpoint)
Secondary outcomes (5)
- measure
- Percentage of lung cancer addressed to radical surgery treatment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * current or former smoker status; * for former smokers, the maximum time since quitting smoking must be below 10 years; * smoking history of at least 20 pack-years; * age 45-80 years; * no previous history of cancer in the 10 years before the beginning of the study; * be able to stand and hold the breath for 11 seconds during image acquisition; * previous participation to SOS trial. Exclusion Criteria: * pregnancy
References
Publications (2)
- RESULTTerzi A, Bertolaccini L, Viti A, Comello L, Ghirardo D, Priotto R, Grosso M; SOS Study Group. Lung cancer detection with digital chest tomosynthesis: baseline results from the observational study SOS. J Thorac Oncol. 2013 Jun;8(6):685-92. doi: 10.1097/JTO.0b013e318292bdef. PMID 23612466
- RESULTBertolaccini L, Viti A, Tavella C, Priotto R, Ghirardo D, Grosso M, Terzi A; SOS Study Group. Lung cancer detection with digital chest tomosynthesis: first round results from the SOS observational study. Ann Transl Med. 2015 Apr;3(5):67. doi: 10.3978/j.issn.2305-5839.2015.03.41. PMID 25992366