Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05968898
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2023-07-21
Brief Title:
Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Pulmonary nodulES
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Abramson Cancer Center at Penn Medicine
Study Overview
Official Title:
Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Cancer Risk Stratification of Pulmonary Nodules
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARCADES
Brief Summary:
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 11 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
Detailed Description:
Accurate malignancy risk stratification of pulmonary nodules PNs is critical to ensuring that cancer is diagnosed in a timely manner and patients do not undergo unnecessary diagnostic procedures Preliminary data suggests that a radiomics-based lung cancer prediction LCP computer-aided diagnosis CAD tool is effective in risk stratifying PNs and may improve clinicians PN management decisions This is a pragmatic clinical trial evaluating the effect of this CAD tool on clinicians management of PNs compared to usual care Individuals eligible for this study will include adults aged 35-89 years who are scheduled to be evaluated at a Penn Medicine PN clinic for a newly discovered PN 8-30mm in maximal diameter on CT imaging Exclusion criteria include lack of CT imaging data at the time of index clinic visit thoracic lymphadenopathy by CT size criteria presence of pulmonary masses 3cm in maximal diameter PNs with popcorn calcification consistent with benign etiology pure ground-glass subsolid PNs a history of lung cancer and history of any active cancer within 5 years Enrolled participants will undergo 11 stratified randomization to one of two groups defined by the PN malignancy risk stratification strategy used by evaluating clinicians 1 usual care clinician assessment or 2 clinician assessment CAD-based risk stratification using the LCP-CAD tool The control arm will be usual care defined as routine clinician assessment of PN malignancy risk In the experimental arm clinicians will be provided a report with the CAD tool estimate of malignancy risk for the PN being evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None