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Search / Trial NCT05968898

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

Launched by ABRAMSON CANCER CENTER AT PENN MEDICINE · Jul 28, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Clinical Effectiveness Clinical Utility Artificial Intelligence Medical Decision Making Risk Stratification

ClinConnect Summary

This clinical trial is looking at a new tool that uses advanced imaging technology, called a radiomics-based computer-aided diagnosis (CAD) tool, to help doctors manage pulmonary nodules—small growths in the lung that could be cancerous. The trial will compare the usual medical care that patients receive for these nodules to care that includes this new diagnostic tool. Adults between the ages of 35 and 89 who have recently been diagnosed with specific types of pulmonary nodules, measuring between 8 and 30 millimeters, may be eligible to participate.

If you join the trial, you will be randomly assigned to one of two groups: one will receive the standard care for managing your pulmonary nodules, while the other will receive that same standard care plus the new CAD tool. This means you may have access to additional information that could help your doctor make better decisions about your health. To be eligible, you need to have a recently found nodule that meets certain criteria, and there are some exclusions related to previous cancer history or specific types of nodules. The trial is currently recruiting participants, and it offers a chance to contribute to important research that could improve lung cancer diagnosis and treatment in the future.

Gender

ALL

Eligibility criteria

  • Inclusion 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
  • Exclusion Criteria:
  • 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

About Abramson Cancer Center At Penn Medicine

The Abramson Cancer Center at Penn Medicine is a leading academic institution dedicated to advancing cancer research, treatment, and prevention. As part of the University of Pennsylvania, the center integrates cutting-edge scientific discovery with comprehensive clinical care, offering patients access to innovative therapies and clinical trials. Renowned for its multidisciplinary approach, the Abramson Cancer Center collaborates with experts across various specialties to deliver personalized treatment plans while fostering a supportive environment for patients and their families. Committed to improving outcomes and quality of life for cancer patients, the center is at the forefront of groundbreaking research initiatives and educational programs aimed at transforming cancer care.

Locations

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Patients applied

0 patients applied

Trial Officials

Roger Y. Kim, MD, MSCE

Principal Investigator

University of Pennsylvania

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported