Quantitative Lung Cancer Screening

NCT03622528 | Withdrawn FDA Device

• 1 other identifier: 201603824
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this project is to validate quantitative lung structure assessment using an automated analysis software (VIDA), for application to low dose computed tomography (LDCT) acquired for lung cancer screening. Currently the software runs on standard dose CT data. In addition, it is the plan to incorporate algorithms into the software to address assessment of any identified pulmonary lesions.

Conditions

Pulmonary Disease; Chronic Obstructive Pulmonary Disease; Cancer, Lung

Outcome Measures

Primary Outcomes (1)

• Segmental Airway Branch Differences

  Segmental airway branch differences will be measured by comparing the clinical low dose chest CT scan and the standard dose chest CT scan.

  1 day of Study Visit

Study Arms (1)

Lung Cancer Screening Cohort

Patients who are seen in the UIHC lung cancer screening clinic will be asked to undergo an additional standard chest CT scan during their UIHC clinical lung cancer screening CT scan. Additionally, data from that clinical scan and all medical records associated with nodules that were discovered by the Lung Cancer Screening, will also be collected.

Radiation: Chest CT scan

Interventions

Chest CT scan RADIATION

Standard dose chest CT scan

Lung Cancer Screening Cohort

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be patients at the University of Iowa Hospitals and Clinics that are participating in the Lung Cancer Screening clinic and have met those guidelines for being included in that screening program.

You may qualify if:

• Subjects that meet the clinical Lung Cancer Screening guidelines and participate in that clinical screening.

You may not qualify if:

• Subjects that do not meet the clinical Lung Cancer Screening guidelines.

Sponsors & Collaborators

• Jessica Sieren: lead
• Vida Diagnostics, Inc: collaborator

MeSH Terms

Conditions

Lung Diseases; Pulmonary Disease, Chronic Obstructive; Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Jessica Sieren, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 9, 2018
• Study Start: July 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11