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

NCT03645018 | Completed Phase 3

• 1 other identifier: SOS2
• Study Type: interventional
• Target: 1,341
• Locations: 1 country
• Sites: 1

Brief Summary

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

Lung Cancer

Keywords

lung; cancer; early diagnosis; DTS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Mortality

  1 year

• OS

  1 year

• QoL: quality of life: Percentage of partecipants changing their smoking habits

  1 year

Study Arms (1)

diagnosis with tomosynthesis (DTS)

EXPERIMENTAL

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

Interventions

diagnosis with tomosynthesis DIAGNOSTIC_TEST

Re-evaluation of lung nodule detection rate at 5 years in patients with early diagnosis of lung cancer

diagnosis with tomosynthesis (DTS)

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• pregnancy

Sponsors & Collaborators

• Ospedale Santa Croce-Carle Cuneo: lead
• Fondazione CRC - Cuneo: collaborator
• University of Turin, Italy: collaborator

Study Sites (1)

OSCroceCarle

Cuneo, CN, 12100, Italy

Location

Related Publications (2)

• 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.

  PMID: 23612466 RESULT

• 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.

  PMID: 25992366 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Neoplasms; Disease

Interventions

Diagnosis

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Radiology Dept.

Model Details: Monocenter prospective no-profit single group interventional study.

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: August 24, 2018
• Study Start: September 1, 2017
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: September 14, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)