Biomarker Platform (Virtual Nodule Clinic) for the Management of Indeterminate Pulmonary Nodules
NCT ID: NCT06638398
Last Updated: 2025-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2024-10-31
2027-04-30
Brief Summary
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Detailed Description
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I. To test the hypothesis that usual care plus a radiomic prediction score impacts patient management compared to usual care alone.
II. To conduct a multicenter pragmatic randomized controlled platform trial using a validated biomarker, the radiomic prediction score.
III. To conduct a biomarker study that will evaluate the first necessary (but not sufficient) step to show clinical utility.
IV. To assess the magnitude of change in patient management with use of the radiomic prediction score.
V. To develop a platform that can be used as framework for future larger biomarker studies.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo standard of care (SOC) computed tomography (CT) evaluation and receive a Virtual Nodule Clinic radiomic prediction score on study. Patients then receive SOC lung nodule management on study.
ARM II: Patients undergo SOC CT evaluation on study. Patients then receive SOC lung nodule management on study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Arm I (Radiomic Prediction Score)
Patients undergo SOC CT evaluation and receive a Virtual Nodule Clinic radiomic prediction score on study. Patients then receive SOC lung nodule management on study.
Best Practice
Receive standard of care lung nodule management
Electronic Health Record Review
Ancillary Studies
Computed Tomography
Undergo standard of care Computed Tomography
Diagnostic Procedure
Receive a Virtual Nodule Clinic radiomic prediction score obtained in Optellum software.
Arm II (Usual Care)
Patients undergo SOC CT evaluation on study. Patients then receive SOC lung nodule management on study.
Best Practice
Receive standard of care lung nodule management
Computed Tomography
Undergo standard of care Computed Tomography
Interventions
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Best Practice
Receive standard of care lung nodule management
Electronic Health Record Review
Ancillary Studies
Computed Tomography
Undergo standard of care Computed Tomography
Diagnostic Procedure
Receive a Virtual Nodule Clinic radiomic prediction score obtained in Optellum software.
Eligibility Criteria
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Inclusion Criteria
* Referral includes direct in-basket messages in the electronic healthcare record (EHR) to study providers, telehealth visits or clinic visit
* For multiple nodules, we will obtain the score from the dominant or most suspicious nodule based on providers or radiologist impression
* Available CT scan with slice thickness of 3 mm or less with the nodule of interest present. Nodules identified during screening low dose computed tomography of the chest (LDCT) that have had a conventional, follow-up CT performed are eligible for inclusion
Exclusion Criteria
* Patients known to be a prisoners
* Patients known to be pregnant
* Known active malignancy within the last 5 years at time of enrollment (excluding non-melanoma skin cancers)
* More than 5 IPNs present on imaging
* Nodules referred after initial LDCT for screening with only one LDCT available. The Lung Cancer Prediction Convolutional Neural Network (LCP CNN) algorithm is not currently validated for screening studies
* Thoracic implants that impact the image appearance of the nodule
* Clinician determines that use of the LCP CNN model is required or contraindicated for the optimal care of the patient
35 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Fabien Maldonado
Professor of Medicine
Principal Investigators
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Fabien Maldonado, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University/Ingram Cancer Center
Locations
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University of Colorado
Aurora, Colorado, United States
Washington University in St. Louis
St Louis, Missouri, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
Meharry Medical College
Nashville, Tennessee, United States
VA Tennessee Valley Healthcare Center
Nashville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2024-08453
Identifier Type: REGISTRY
Identifier Source: secondary_id
VICC-IDTHO24059
Identifier Type: -
Identifier Source: org_study_id
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