Actively Recruiting

Phase Not Applicable
Age: 35Years - 89Years
All Genders
NCT05968898

Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Pulmonary nodulES

Led by Abramson Cancer Center at Penn Medicine · Updated on 2025-06-06

300

Participants Needed

3

Research Sites

207 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a pragmatic clinical trial that will study the effect of a radiomics-based computer-aided diagnosis (CAD) tool on clinicians' management of pulmonary nodules (PNs) compared to usual care. Adults aged 35-89 years with 8-30mm PNs evaluated at Penn Medicine PN clinics will undergo 1:1 randomization to one of two groups, defined by the PN malignancy risk stratification strategy used by evaluating clinicians: 1) usual care or 2) usual care + use of a radiomics-based CAD tool.

CONDITIONS

Official Title

Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Pulmonary nodulES

Who Can Participate

Age: 35Years - 89Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, aged 35-89 years
  • Scheduled to be evaluated at a UPHS pulmonary nodule clinic
  • Newly discovered solid or part-solid indeterminate pulmonary nodule 8-30 mm in maximal diameter on CT imaging within 60 days of index clinic visit
  • Chest CT imaging meets technical requirements for compatibility with the Optellum Virtual Nodule Clinic software
Not Eligible

You will not qualify if you...

  • Chest CT imaging showing mediastinal or hilar lymphadenopathy larger than 10 mm in short-axis diameter
  • Pulmonary nodules with popcorn calcification indicating benign cause
  • Pure ground-glass subsolid pulmonary nodules
  • Pulmonary nodule seen on CT imaging more than 60 days before the most recent CT
  • More than one indeterminate pulmonary nodule 8-30 mm in maximal diameter
  • History of lung cancer
  • History of active cancer within the previous 5 years
  • Presence of a thoracic implant that prevents visualization of pulmonary nodules

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

Penn Medicine University City

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

2

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

3

Penn Medicine Washington Square

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

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Research Team

R

Roger Y. Kim, MD, MSCE

CONTACT

A

Anil Vachani, MD, MSCE

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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