RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-01-09
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05968898

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.

Ages Eligible for Study:35 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female, aged 35-89 years
  2. 2. Scheduled to be evaluated at a UPHS PN clinic
  3. 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. 4. Chest CT imaging meeting the technical requirements for compatibility with Optellum Virtual Nodule Clinic software
  1. 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. 2. PNs with popcorn calcification (consistent with benign etiology)
  3. 3. Pure ground-glass subsolid PNs (may be associated with lower risk of clinically significant malignancy)
  4. 4. PN previously seen on CT imaging \>60 days prior to most recent CT
  5. 5. More than one indeterminate PN 8-30mm in maximal diameter
  6. 6. History of lung cancer
  7. 7. History of active cancer within the previous 5 years
  8. 8. Presence of a thoracic implant that impedes PN visualization

Contacts and Locations

Study Contact

Roger Y. Kim, MD, MSCE
CONTACT
215-662-3677
roger.kim@pennmedicine.upenn.edu
Anil Vachani, MD, MSCE
CONTACT
215-573-7931
avachani@pennmedicine.upenn.edu

Principal Investigator

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

Study Locations (Sites)

Penn Medicine University City
Philadelphia, Pennsylvania, 19104
United States
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
United States
Penn Medicine Washington Square
Philadelphia, Pennsylvania, 19107
United States

Collaborators and Investigators

Sponsor: Abramson Cancer Center at Penn Medicine

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-09
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-01-09
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • clinical effectiveness
  • clinical utility
  • artificial intelligence
  • medical decision-making
  • risk stratification

Additional Relevant MeSH Terms

  • Lung Cancer
  • Pulmonary Nodule, Solitary