Lung Cancer Early Diagnosis With Digital Tomosynthesis: Re-evaluation of Lung Nodule Detection Rate at 5 Years (SOS2)

A Monocenter Prospective No-profit Interventional Study for Lung Cancer Early Diagnosis With Tomosynthesis: Re-evaluation of Lung Nodule Detection Rate at 5 Years

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Diagnostic test: diagnosis with tomosynthesis

Detailed Description

Lung cancer is the leading cause of cancer-related death around the world. In 2008 there were nearly 1.6 million new cases worldwide, accounting for the 12.7% of all new cancer diagnoses. Despite decreasing trends in smoking and resulting decrease in lung cancer mortality, the population at risk for lung cancer continues to be large. In the past years several programs have been developed to screen for lung cancer using low-dose chest computed radiography (CT). However, only recently different studies demonstrated a clear reduction in mortality. In particular, NLST low dose CT screening trial demonstrated a 6.7% reduction in the death rate compared to chest X-ray with a positive screening test rate for lung cancer detection of 24.2%, compared to 6.9% for conventional X-ray. Digital tomosynthesis (DTS) is a limited angle tomography that allows reconstruction of multiple image planes from a set of projection data acquired over a relatively small angle of X-ray tube movement. Although it does not have the spatial depth resolution of computed tomography, it provides high-resolution images in the sagittal planes at a lower dose and cost than CT. Several studies have shown that DTS offers advantages over conventional chest X-ray and comparable of those of CT. The Studio OSservazionale (SOS) was a clinical trial conducted within Santa Croce e Carle Hospital analysing smokers and former smokers aged 45-80 with no cancer diagnosis. All the subjects in whom a suspicious nodule was detected by DTS underwent diagnostic CT. The SOS study demonstrated that baseline DTS detected pulmonary abnormalities in 14.5% and lung cancer in 1.0% of the subjects, comparable to results that are obtained in CT screening programs. A second DTS, within the same study, executed one year later reported pulmonary abnormalities in 0.7% and lung cancer in 0.3% of the subjects.

• Study Type: Interventional
• Enrollment (Actual): 1341
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • CN
    • Cuneo, CN, Italy, 12100
      • OSCroceCarle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: diagnosis with tomosynthesis (DTS); Single arm. Population: Subjects enrolled in previously closed SOS trial (high risk subjects for lung cancer) without confirmed lung cancer.	Diagnostic test: diagnosis with tomosynthesis; Re-evaluation of lung nodule detection rate at 5 years in patients with early diagnosis of lung cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Lung cancer detection rate (primary endpoint)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality		1 year
OS	Overall survival	1 year
Percentage of lung cancer addressed to radical surgery treatment		1 year
Sensitivity of DTS evaluating the number of lung cancer occurred in the population of SOS study in the last 5 years		1 year
QoL: quality of life: Percentage of partecipants changing their smoking habits	Percentage of partecipants changing their smoking habits after trial	1 year

Collaborators and Investigators

• Sponsor: Ospedale Santa Croce-Carle Cuneo
• Collaborators: University of Turin, Italy; Fondazione CRC - Cuneo

Publications and helpful links

General Publications

• Terzi 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.
• Bertolaccini 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: July 20, 2018
• First Submitted That Met QC Criteria: August 23, 2018
• First Posted (Actual): August 24, 2018

Study Record Updates

• Last Update Posted (Actual): September 14, 2018
• Last Update Submitted That Met QC Criteria: September 13, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: lung; cancer; early diagnosis; DTS
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: SOS2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No