Next Generation Chest X-Ray Tomosynthesis for Screening o... | NCT06577883

Studies
Next Generation Chest X-Ray Tomosynthesis for Screening of Lung Cancer

NCT06577883

Sponsor

University of California, San Diego

Status

Recruiting

Last Update Posted

Aug 29, 2024Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Lung Cancer

Interventions

Chest X-ray Tomosynthesis

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2, 2023Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Jun 30, 2027Estimated

First Submitted Date

Aug 27, 2024

First Submission Date that Met QC Criteria

Aug 27, 2024

First Posted Date

Aug 29, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2024

Last Update Posted Date

Aug 29, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Albert Hsiao, Professor in Residence, Department of Radiology, University of California, San DiegoPrincipal Investigator

Lead Sponsor

University of California, San DiegoOTHER

Collaborators

Name	Class
AIxSCAN, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational clinical trial is to learn if chest tomosynthesis is a potential alternative to computed tomography for the detection of lung cancer. It will also develop artificial intelligence tools to aid in the diagnosis of lung cancer on chest tomosynthesis images. The main questions it aims to answer are:

What is the accuracy of chest X-ray tomosynthesis in diagnosing lung cancer in a population of individuals undergoing lung cancer screening or evaluation of a suspicious lung nodule?
Can artificial intelligence help us detect lung cancer on chest tomosynthesis images?

Researchers will compare chest tomosynthesis images to computed tomography scans for each participant to see how they compare in diagnosing lung cancer.

Participants will a chest tomosynthesis scan in addition to their routine clinical computed tomography scan.

Detailed Description

Lung cancer remains the most common cause of cancer death in the United States for which low-dose CT has proven benefit for early detection and survival from lung cancer. However, adoption remains low. Furthermore, >95% of nodules detected on low-dose CT, especially those smaller than 6 mm, do not represent cancer. We have partnered to develop a novel chest x-ray tomosynthesis (CXRT) device with the hypothesis that this device might be an alternative to CT for detection of lung cancer. We seek to recruit a cohort of patients to undergo CXRT, composed of patients concurrently undergoing lung cancer screening CT and diagnostic CT for new lung cancer. We will determine the effectiveness of CXRT for detecting lung cancer in this population, evaluating its sensitivity and specificity for detecting cancer and lung nodules at multiple size thresholds in a multireader study. We will additionally develop artificial intelligence algorithms and evaluate their efficacy to further enhance cancer detection.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chest X-ray Tomosynthesis Participants		Participants who had a recent, routine clinical chest computed tomography scan for lung cancer screening or evaluation of nodule suspicious for lung cancer will undergo an additional chest X-ray tomosynthesis scan.	Diagnostic Test: Chest X-ray Tomosynthesis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chest X-ray Tomosynthesis	Diagnostic Test	An imaging device that uses X-rays projected from multiple angles to reconstruct a three-dimensional images of the chest	Chest X-ray Tomosynthesis Participants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Chest X-ray tomosynthesis detection of lung cancer	Diagnostic accuracy of chest tomosynthesis in identifying biopsy-proven lung cancer	through 12/31/2026

Secondary Outcomes

Measure	Description	Time Frame
Chest X-ray tomosynthesis detection of suspicious nodules	Diagnostic accuracy of chest tomosynthesis in identifying pulmonary nodules seen on chest CT at multiple minimum size thresholds: 6-mm, 8-mm, 10-mm	through 12/31/2026

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

undergoing lung cancer screening
undergoing evaluation of suspicious pulmonary nodule
newly diagnosed lung cancer

Exclusion Criteria:

prior history of lung cancer treatment

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing lung cancer screening CT or undergoing diagnostic chest CT for incidentally detected pulmonary nodules or lung cancer.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alexander Cypro, MD	Contact	858-2462196		aidaresearch2023@gmail.com

Overall Officials

Name	Affiliation	Role
Albert Hsiao, MD PhD	UC San Diego, Department of Radiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California San Diego	Recruiting	San Diego	California	92093	United States

Label	URL
AIxScan, Inc	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided