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WithdrawnNCT03622528Updated Nov 27, 2024

Quantitative Lung Cancer Screening

An observational study in Pulmonary Disease, Chronic Obstructive Pulmonary Disease and Cancer, Lung, sponsored by Jessica Sieren. Withdrawn. Open to participants aged 50 Years to 74 Years. Per ClinicalTrials.gov, last updated 2024-11-27.

Sponsored by Jessica Sieren · Observational

Why this study was withdrawn
Funding Issues
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
0
Ages
50 Years to 74 Years
Sex
All
01

Study 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.

Read the detailed description

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.

The Lung Cancer Screening Clinic is a new program that screens a group of patients that meet a predetermined criteria, set by the program, for lung cancer. At this time primary care providers, within the UIowa network, have the ability to place an order for this screening process for their patients. The hope is to expand this program to any primary care provider in the future. Clinic staff look over the patients past medical history to determine if they fit the clinic criteria.

For this study, the study team will ask the patients seen in the lung cancer screening clinic at the University of Iowa to undergo an additional standard dose CT scan during that same visit(for comparison/validation of the software performance). For those subjects that agree to participate, the study team will also ask to collect the data and CT scans that were also collected for their clinical Lung Cancer Screening visit. For this group the study team will also ask to collect all medical records associated with nodules found at this Lung Cancer Screening visit.

The study team propose to test the performance of VIDA's existing image analysis tools for the assessment of chronic obstructive pulmonary disease (COPD), when applied to the LDCT data acquired for lung cancer screening. The study team will also develop new lung nodule evaluation functions to specifically address the clinical needs within the at-risk lung cancer patient population.

To carry out the work, the study team propose two specific aims:

  1. Validate VIDA's quantitative computed tomography (QCT) metrics for COPD and emphysema utilizing the lung cancer LDCT screening cohort as compared to the standard quantitative high resolution computed tomography (HRCT) scanning protocol. With collaboration between the University of Iowa and VIDA, the study team will establish a tightly controlled, CT data acquisition protocol in our local lung cancer screening program. Data collected will incorporate thin-slice and iterative reconstructions, breath coaching to target lung inflation levels for patients and HRCT data acquisition in a sub-cohort. The VIDA analysis will be refined and the appropriate reconstruction setting identified such that the outputs from the LDCT data correlate to the HRCT (current standard) outputs.
  2. Complete and refine development of VIDA's novel lung nodule segmentation algorithm for solid and non-solid nodules using the standardized lung cancer LDCT screening protocol. Automated nodule segmentation in CT scans is challenging due to border ambiguity with neighboring structures (such as vessels and the pleura), poor boundary contrast of more subtle nodules, and noise associated with LDCT. The study team will develop a novel method that robustly segments pulmonary lesions by allowing mutual interaction between the nodules and surrounding structures, leading to a highly accurate segmentation with less manual corrective actions for a high volume lung cancer screening workflow.
02

Conditions studied

  • Pulmonary Disease
  • Chronic Obstructive Pulmonary Disease
  • Cancer, Lung
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

Browse Lung Neoplasms studies →

Lead sponsor

This is the only study on the registry with Jessica Sieren as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 74 Years
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Subjects that do not meet the clinical Lung Cancer Screening guidelines.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • RadiationChest CT scan

    Standard dose chest CT scan

06

What researchers measure

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.

    Time frame: 1 day of Study Visit

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03622528
Lead sponsor
Jessica Sieren
Collaborators
Vida Diagnostics, Inc
Responsible party
Jessica Sieren (Assistant Professor, University of Iowa) — Sponsor-investigator
First posted
Aug 9, 2018
Start date
Jul 2024 (estimated)
Primary completion
Oct 2024 (estimated)
Completion
Oct 2024 (estimated)
Last update
Nov 27, 2024

Study contacts

Jessica Sieren, PhD
principal investigator · University of Iowa

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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