Last reviewed · How we verify
NCT06576232: REALITY
Standalone Observational Study Assessing the Performance of an AI/ML Tech-based SaMD on Chest LDCT Images (REALITY)
trial testing Median LCS in High Risk Cancer in 1,147 participants. Completed in 21 August 2024.
24 July 2024
Quick facts
| Lead sponsor | Median Technologies |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,147 |
| Start date | 21 September 2022 |
| Primary completion | 24 July 2024 |
| Estimated completion | 21 August 2024 |
| Sites | 5 locations across United States, Spain |
Drugs / interventions tested
- Median LCS
Conditions studied
- High Risk Cancer — all drugs for High Risk Cancer →
Sponsor
Median Technologies
Who can join
Adults 50 to 80, any sex, with High Risk Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Multinational, Multicenter, retrospective study for the evaluation of the standalone efficacy and safety of an Artificial Intelligence/Machine Learning (AI/ML) technology-based end-to-end Computer assisted Detection/Computer Assisted Diagnosis (CADe/CADx) Software as a Medical Device (SaMD) developed to detect, localize and characterize malignant, and suspicious for lung cancer nodules on Low Dose Computed Tomography (LDCT) scans taken as part of a Lung Cancer Screening (LCS) program. LDCT Digital Imaging and Communications in Medicine (DICOM) images of patients who underwent lung cancer screening were selected and included into the study. Selected scans will then be analyzed by the CADe/CADx SaMD and compared to radiologist generated reference standards including lesions localization and lesion cancer diagnosis. Figures of merit at patient level and lesion level detection and diagnostic efficacy will be calculated as well as sub-class analysis to ensure algorithm performance generalizability.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Artificial Intelligence in Oncology: A 10-Year ClinicalTrials.gov-Based Analysis Across the Cancer Control Continuum.
Verma H, Mistry S, Jayam KV, Shrestha P, et al · · 2025 · PMID 41228330 · DOI 10.3390/cancers17213537
Verify or expand the search:
- PubMed search for NCT06576232
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Median LCS
Trials testing the same drug.
- NCT06751576 — Retrospective Clinical Trial Comparing Radiologists' Diagnosis Accuracy in Lung Cancer Screening Population With and Wit · completed
Other recruiting trials for High Risk Cancer
Currently open trials in the same condition.
- NCT05013216 — Mutant KRAS -Targeted Long Peptide Vaccine for Patients at High Risk of Developing Pancreatic Cancer · Phase 1 · recruiting
Other Median Technologies trials
Trials by the same sponsor.
- NCT06751576 — Retrospective Clinical Trial Comparing Radiologists' Diagnosis Accuracy in Lung Cancer Screening Population With and Wit · completed
- NCT05038826 — BICR in New Therapeutic Lung Cancer Trials · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06576232 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Median Technologies
- Last refreshed: 28 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06576232.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing