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

Description

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

Lung Cancer, Pulmonary Nodule, Solitary

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Study Overview

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Study Details

Study overview

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.

Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Cancer Risk Stratification of Pulmonary Nodules

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

Condition
Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Philadelphia

Penn Medicine University City, Philadelphia, Pennsylvania, United States, 19104

Philadelphia

Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania, United States, 19104

Philadelphia

Penn Medicine Washington Square, Philadelphia, Pennsylvania, United States, 19107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Male or female, aged 35-89 years
  • 2. Scheduled to be evaluated at a UPHS PN clinic
  • 3. Newly discovered solid or part-solid indeterminate PN 8-30mm in maximal diameter on CT imaging within 60 days of index clinic visit
  • 4. Chest CT imaging meeting the technical requirements for compatibility with Optellum Virtual Nodule Clinic software
  • 1. Chest CT imaging with discrete mediastinal or hilar lymphadenopathy by CT size criteria (\>10mm in maximal short-axis diameter on axial CT images)
  • 2. PNs with popcorn calcification (consistent with benign etiology)
  • 3. Pure ground-glass subsolid PNs (may be associated with lower risk of clinically significant malignancy)
  • 4. PN previously seen on CT imaging \>60 days prior to most recent CT
  • 5. More than one indeterminate PN 8-30mm in maximal diameter
  • 6. History of lung cancer
  • 7. History of active cancer within the previous 5 years
  • 8. Presence of a thoracic implant that impedes PN visualization

Ages Eligible for Study

35 Years to 89 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Abramson Cancer Center at Penn Medicine,

Roger Y. Kim, MD, MSCE, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

2027-12-31