Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638398
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Biomarker Platform Virtual Nodule Clinic for the Management of Indeterminate Pulmonary Nodules
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessing a Biomarker Platform for Stratifying Indeterminate Pulmonary Nodules - The SPOT IT Platform Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial studies whether a biomarker platform the Virtual Nodule Clinic can be used for the management of lung pulmonary nodules that are not clearly non-cancerous benign or clearly cancerous malignant indeterminate pulmonary nodules IPNs The management of IPNs is based on estimating the likelihood that the observed nodule is malignant Many things such as age smoking history and current symptoms are considered when making a prediction of the likelihood of malignancy Radiographic imaging characteristics are also considered Lung nodule management for IPNs can result in unnecessary invasive procedures for nodules that are ultimately determined to be benign or potential delays in treatment when results of tests cannot be determined or are falsely negative The Virtual Nodule Clinic is an artificial intelligence AI based imaging software within the electronic health record which makes certain that identified pulmonary nodules are screened by clinicians with expertise in nodule management The Virtual Nodule Clinic also features an AI based radiomic prediction score which designates the likelihood that a pulmonary nodule is malignant This may improve the ability to manage IPNs and lower unnecessary invasive procedures or treatment delays Using the Virtual Nodule Clinic may work better for the management of IPNs
Detailed Description:
PRIMARY OBJECTIVES
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None