Clinical trial NCT06751576: Retrospective Clinical Trial Comparing Radiologists' Diagnosis Accuracy in Lung Cancer Screening Population With and Without the Help of an AI/ML Tech-based SaMD
Official title: A Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Comparative Accuracy Of Readers Assisted By an AI/ML Technology-Based End-To-End CADe/CADx SaMD Versus Alone in the Detection, Localization and Characterization of Pulmonary Nodules in Populations With High Risk of Lung Cancer (RELIVE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High Risk Cancer
Lung Cancer
Lead sponsor: Median Technologies
Sponsor class: INDUSTRY
First posted: 2024-12-30
Enrollment: 480
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: High risk lung cancer population from Radiology or Pneumology hospital departments.

Patients enrolled in this study were retrospectively collected from centers across the EU and USA where they were enlisted into lung cancer screening due to high risk of lung cancer according to established lung cancer screening guidelines.

The cohort used for testing the efficacy and safety of the device will be an "enriched cohort" with a 1:2 distribution of cancer positive and benign patients

Brief summary: This is a two arm, randomized, controlled, blinded, multi-case multi reader (MRMC), retrospective study for the evaluation of the efficacy and safety of an AI/ML technology-based CADe/x developed to detect, localize and characterize malignancy score of pulmonary nodules on LDCT chest scans taken as part of a lung cancer screening program.

LDCT DICOM images of patients who underwent routine lung cancer screening will be selected and enrolled into the study. Enrolled scans analyzed by radiologists with the assistance of the Median LCS (formerly iBiopsy) device are compared to the analysis by radiologists without the assistance of the Median LCS device.

Figures of merit for patient level and lesion level detection and diagnostic efficacy will be calculated and compared, sub-class analysis will be performed to ensure device generalizability.


Eligibility criteria: Inclusion Criteria:

* ≥50-80 Years of age;
* Current or ex-smoker (\>=20 pack years);
* Patient screened and surveilled for lung cancer screening following lung cancer screening guidelines (equivalent to United States Preventive Services Task Force (USPSTF) 2021 Criteria);
* Received LDCT due to inclusion in high-risk category for lung cancer.

Exclusion Criteria:

* Prior lung resection;
* Pacemaker or other indwelling metallic medical devices in the thorax that interfere with CT acquisition;
* Patients/images used during AI model development;
* Patients with only hilar and/or mediastinal cancer(s);
* Patients with only ground glass cancer(s);
* Patients with nodules, solid or part-solid \>30mm (masses);
* Patients that are not accompanied with the required clinical information;
* Patients with imaging with any of the following: missing slices, slice thickness \>3mm;
* Partial cover of the lung.

Primary outcomes:
measure: ∆ AUC of ROCs > 0. Delta Area between the Response operating curve (AUROC) value with Median LCS and AUROC without Median LCS at patient level data is superior to 0.
timeFrame: 12 months
Secondary outcomes:
measure: Sensitivity at max Youden
timeFrame: 12 months
measure: Specificity at max Youden
timeFrame: 12 months
measure: ∆ AUC of LROC > 0
timeFrame: 12 months
measure: Recall rates for non-cancer patients (Specificity)
timeFrame: 12 months
measure: Recall rates for cancer patients (Sensitivity)
timeFrame: 12 months
measure: Time analysis
timeFrame: 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania - Penn Center for Innovation
state: Pennsylvania
city: Memphis
country: United States
facility: Baptist Clinical Research Institute
state: Tennessee
city: Houston
country: United States
facility: The University of Texas M.D. Anderson Cancer Center
state: Texas
city: Madrid
country: Spain
facility: Fundacion instituto de investigacion sanitaria de la fundacion jimenez diaz (FJD)
city: Pamplona
country: Spain
facility: Universidad de Navarra
Study officials:
affiliation: University of Pennsylvania
name: Anil VACHANI, MD
role: PRINCIPAL_INVESTIGATOR
References: