Clinical trial · Interventional
Evaluation of Computer-Aided Lung Nodule Detection Software in Thoracic CT for Riverain Technologies LLC
Computer-Aided System for the Improvement of Nodule Detection and Characterization in Thoracic CT Based on a Novel Vessel Suppressed CT Volume
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
STUDY DESIGN: This is a retrospective, multi-reader, multi-case, (MRMC) randomized reader study. OBJECTIVE: Primary: The primary objective of this clinical study is to prove that a user aided with ClearRead CT InSight (CRCTI) is superior to the unaided reader for detecting actionable lung nodules. Secondary: The secondary objective of this clinical study is to prove that the reader's reading time is not significantly increased when aided with CRCTI. NUMBER OF SUBJECTS: Retrospective CT studies from approximately 300 patients will be included in the study. Approximately 100 true positive cases and 200 normal cases. NUMBER OF READERS: A reader study with at least ten (10) participating radiologists (US Board Certified) will be conducted. PRIMARY ENDPOINTS: Scores given by the radiologists with and without ClearRead CT Insight will be recorded and compared to the true status of the study-cases. The frequency of the scores for each method (Unaided, Aided) will be tabulated and LROC curves constructed along with sensitivity, specificity, PPV, NPV and clinical actions. Additionally, machine nodule detection rate and false positives per patient on normal cases will be measured. PATIENT POPULATION : The study will target approximately one hundred (100) patients whose CT nodules were shown to be cancer and two hundred (200) normal patients. The patient population will be consistent with the national lung cancer screening protocols.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ClearRead CT Insight | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Arm 1
- description
- Participating radiologists will perform clinical reading on \~300 cases. They will mark all locations of concern (clinically actionable nodules) on conventional thoracic CT images. Computer will measure time, readers score regions according to action and suspiciousness.
- type
- ACTIVE_COMPARATOR
- label
- Arm 2
- description
- Participating radiologists will perform clinical reading on \~300 cases. They will mark all locations of concern (clinically actionable nodules) on thoracic CT images aided by ClearRead CT Insight software as the intervention. Computer will measure time, readers score regions according to action and suspiciousness.
- interventionNames
- Device: ClearRead CT Insight
Primary outcomes (2)
- measure
- Comparing the Detection Accuracy, Sensitivity, and Specificity of Clinically Actionable Lung Nodules
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 77 Years
Show eligibility criteria text
Inclusion Criteria: A thoracic CT case that is associated or with a feature of the following: 1. Asymptomatic patients age 55 - 77 with history of smoking 2. Primary Lung Cancer 3. Biopsy Proven (LuRADS 5) with radiology report 4. Screen detected event plus 1 prior CT. 2 year of prior CTs is preferred, if available. 5. \<= 3mm slice spacing, no gaps 6. Use standard reconstruction kernels 7. Maximum of 5 nodules per image 8. Nodules must be 5-20mm in size 9. With or without contrast Exclusion Criteria: Thoracic CT cases that meet the following exclusion criteria will not be collected for use during clinical testing. 1. No Acute pneumothorax 2. Both lungs must be fully visible within the field of view 3. Apices cannot be cropped 4. No excessive motion artifacts 5. Symptomatic patients with co-morbidities
References
Publications (6)
- BACKGROUNDBeyer F, Zierott L, Fallenberg EM, Juergens KU, Stoeckel J, Heindel W, Wormanns D. Comparison of sensitivity and reading time for the use of computer-aided detection (CAD) of pulmonary nodules at MDCT as concurrent or second reader. Eur Radiol. 2007 Nov;17(11):2941-7. doi: 10.1007/s00330-007-0667-1. Epub 2007 May 22. PMID 17929026
- BACKGROUNDDorfman DD, Berbaum KS, Metz CE. Receiver operating characteristic rating analysis. Generalization to the population of readers and patients with the jackknife method. Invest Radiol. 1992 Sep;27(9):723-31. No abstract available. PMID 1399456
- BACKGROUNDFoti G, Faccioli N, D'Onofrio M, Contro A, Milazzo T, Pozzi Mucelli R. Evaluation of a method of computer-aided detection (CAD) of pulmonary nodules with computed tomography. Radiol Med. 2010 Sep;115(6):950-61. doi: 10.1007/s11547-010-0556-6. Epub 2010 Jun 23. English, Italian. PMID 20574707
- BACKGROUNDMatsumoto S, Ohno Y, Aoki T, Yamagata H, Nogami M, Matsumoto K, Yamashita Y, Sugimura K. Computer-aided detection of lung nodules on multidetector CT in concurrent-reader and second-reader modes: a comparative study. Eur J Radiol. 2013 Aug;82(8):1332-7. doi: 10.1016/j.ejrad.2013.02.005. Epub 2013 Mar 6. PMID 23480965
- BACKGROUNDObuchowski NA. New methodological tools for multiple-reader ROC studies. Radiology. 2007 Apr;243(1):10-2. doi: 10.1148/radiol.2432060387. No abstract available. PMID 17392244
- BACKGROUNDObuchowski NA, McClish DK. Sample size determination for diagnostic accuracy studies involving binormal ROC curve indices. Stat Med. 1997 Jul 15;16(13):1529-42. doi: 10.1002/(sici)1097-0258(19970715)16:133.0.co;2-h. PMID 9249923