AI-Augmented Diagnostic Assessment With ENLIGHT Versus Independent Pathologist Review (ENLIGHT)
This study will evaluate whether artificial intelligence (AI) can enhance clinicians' accuracy, efficiency, and confidence in distinguishing lung adenocarcinoma (LUAD) from lung squamous cell carcinoma (LUSC) and kidney renal papillary cell carcinoma (KIRP) from kidney renal clear cell carcinoma (KIRC) using digitized pathology slides. These subtype classifications are routinely performed by pathologists but can be challenging and time-consuming, particularly in difficult cases.
During the study, participating clinicians will review lung and kidney pathology slides under three different conditions:
- Unaided Review: Diagnosis without AI assistance.
- AI as Double-Check: The clinician first makes an independent diagnosis, after which the AI-generated diagnosis (prediction only or prediction with explanation) is revealed for review.
- AI as First-Look: The AI-generated diagnosis (prediction only or prediction with explanation) is presented before the clinician begins the review.
Clinicians will be randomly assigned to different review sequences to minimize potential order effects. This study design will enable us to assess the impact of AI assistance on diagnostic accuracy, interpretation time, and clinician confidence.
Studieöversikt
Status
Betingelser
Intervention / Behandling
- Beteende: Unaided Review First, Then AI as Double-Check, Then AI as First-Look.
- Beteende: Unaided Review First, Then AI as First-Look, Then AI as Double-Check.
- Beteende: AI as Double-Check First, Then AI as First-Look, Then Unaided Review.
- Beteende: AI as First-Look First, Then AI as Double-Check, Then Unaided Review.
Detaljerad beskrivning
This study aims to evaluate the effect of artificial intelligence (AI) assistance on clinicians' diagnostic performance in distinguishing lung adenocarcinoma (LUAD) from lung squamous cell carcinoma (LUSC) and kidney renal papillary cell carcinoma (KIRP) from kidney renal clear cell carcinoma (KIRC) using digitized hematoxylin and eosin (H&E)-stained whole-slide images (WSIs). ENLIGHT (Explainable Neoplasm Learning In Grounded Histology Terms) will serve as the AI system under evaluation. This is a single-session, within-reader, between-case study in which each reader evaluates distinct sets of cases under all study conditions.
The study includes three diagnostic blocks: Block X, in which WSIs are reviewed without AI assistance; Block Y1, in which clinicians make an initial diagnosis before viewing the AI output as a double-check; and Block Y2, in which the AI output is displayed before clinicians begin their review as a first-look aid. Within each AI-assisted block, the prediction-only and prediction-with-explanation sub-blocks are presented in randomized order.
Each participating pathologist will review up to 400 de-identified WSIs (up to 200 lung cancer and up to 200 kidney cancer cases). Readers will be randomly assigned to one of four study arms that differ only in the order in which Blocks X, Y1, and Y2 are completed. For each reader, distinct WSIs will be randomly assigned to the diagnostic conditions so that no WSI is reviewed more than once by the same reader.
- Arm 1 (X -> Y1 -> Y2): Clinicians first complete Block X (Unaided Review), followed by Block Y1 (AI as Double-Check) and then Block Y2 (AI as First-Look).
- Arm 2 (X -> Y2 -> Y1): Clinicians first complete Block X (Unaided Review), followed by Block Y2 (AI as First-Look) and then Block Y1 (AI as Double-Check).
- Arm 3 (Y1 -> Y2 -> X): Clinicians first complete Block Y1 (AI as Double-Check), followed by Block Y2 (AI as First-Look), and then Block X (Unaided Review).
- Arm 4 (Y2 -> Y1 -> X): Clinicians first complete Block Y2 (AI as First-Look), followed by Block Y1 (AI as Double-Check), and then Block X (Unaided Review).
For each case, diagnostic accuracy, time to diagnosis, and diagnostic confidence will be recorded. No reader will review the same WSI under more than one condition, thereby eliminating within-reader recall bias. In parallel, the ENLIGHT model will independently generate diagnostic predictions for all WSIs to enable direct benchmarking of AI performance against pathologists and to evaluate the impact of different AI-assisted workflows on diagnostic performance.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02115
- Harvard Medical School,
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria for Pathology Slides (i.e., Cases):
- Hematoxylin and eosin (H&E)-stained pathology slides
- Final diagnosis confirmed through molecular testing in conjunction with expert pathology evaluation
Exclusion Criteria for Pathology Slides (i.e., Cases):
- Poor-quality or unreadable slides
- Cases used in AI training
Inclusion Criteria for Readers (i.e., Participants):
- Board-certified or board-eligible pathologists
- Willingness to complete both unaided and AI-assisted review sessions
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Unaided Review First, Then AI as Double-Check, Then AI as First-Look.
Readers first complete Block X (Unaided) on their assigned subset SX.
They then complete Block Y1 (AI as Double-Check) on two separate subsets: SY1a (AI prediction-only as Double-Check) and SY1b (AI prediction-with-explanation as Double-Check).
Within Block Y1, the order of SY1a and SY1b is randomized.
They then complete Block Y2 (AI as First-Look) on two separate subsets: SY2a (AI prediction-only as First-Look) and SY2b (AI prediction-with-explanation as First-Look).
Within Block Y2, the order of SY2a and SY2b is randomized.
For each reader, each of the five subsets (SX, SY1a, SY1b, SY2a, and SY2b) comprises up to 80 slides: up to 40 slides from LUAD-LUSC and up to 40 slides from KIRP-KIRC.
|
Readers first complete Block X (Unaided) on their assigned subset SX.
They then complete Block Y1 (AI as Double-Check) on two separate subsets: SY1a (AI prediction-only as Double-Check) and SY1b (AI prediction-with-explanation as Double-Check).
Within Block Y1, the order of SY1a and SY1b is randomized.
They then complete Block Y2 (AI as First-Look) on two separate subsets: SY2a (AI prediction-only as First-Look) and SY2b (AI prediction-with-explanation as First-Look).
Within Block Y2, the order of SY2a and SY2b is randomized.
For each reader, SX, SY1a, SY1b, SY2a, and SY2b are disjoint.
|
|
Aktiv komparator: Unaided Review First, Then AI as First-Look, Then AI as Double-Check.
Readers first complete Block X (Unaided) on their assigned subset SX.
They then complete Block Y2 (AI as First-Look) on two separate subsets: SY2a (AI prediction-only as First-Look) and SY2b (AI prediction-with-explanation as First-Look).
Within Block Y2, the order of SY2a and SY2b is randomized.
They then complete Block Y1 (AI as Double-Check) on two separate subsets: SY1a (AI prediction-only as Double-Check) and SY1b (AI prediction-with-explanation as Double-Check).
Within Block Y1, the order of SY1a and SY1b is randomized.
For each reader, each of the five subsets (SX, SY1a, SY1b, SY2a, and SY2b) comprises up to 80 slides: up to 40 slides from LUAD-LUSC and up to 40 slides from KIRP-KIRC.
|
Readers first complete Block X (Unaided) on their assigned subset SX.
They then complete Block Y2 (AI as First-Look) on two separate subsets: SY2a (AI prediction-only as First-Look) and SY2b (AI prediction-with-explanation as First-Look).
Within Block Y2, the order of SY2a and SY2b is randomized.
They then complete Block Y1 (AI as Double-Check) on two separate subsets: SY1a (AI prediction-only as Double-Check) and SY1b (AI prediction-with-explanation as Double-Check).
Within Block Y1, the order of SY1a and SY1b is randomized.
For each reader, SX, SY1a, SY1b, SY2a, and SY2b are disjoint.
|
|
Aktiv komparator: AI as Double-Check Review First, Then AI as First-Look, Then Unaided Review.
Readers first complete Block Y1 (AI as Double-Check) on two separate subsets: SY1a (AI prediction-only as Double-Check) and SY1b (AI prediction-with-explanation as Double-Check).
Within Block Y1, the order of SY1a and SY1b is randomized.
They then complete Block Y2 (AI as First-Look) on two separate subsets: SY2a (AI prediction-only as First-Look) and SY2b (AI prediction-with-explanation as First-Look).
Within Block Y2, the order of SY2a and SY2b is randomized.
Then readers complete Block X (Unaided) on their assigned subset SX.
For each reader, each of the five subsets (SX, SY1a, SY1b, SY2a, and SY2b) comprises up to 80 slides: up to 40 slides from LUAD-LUSC and up to 40 slides from KIRP-KIRC.
|
Readers first complete Block Y1 (AI as Double-Check) on two separate subsets: SY1a (AI prediction-only as Double-Check) and SY1b (AI prediction-with-explanation as Double-Check).
Within Block Y1, the order of SY1a and SY1b is randomized.
They then complete Block Y2 (AI as First-Look) on two separate subsets: SY2a (AI prediction-only as First-Look) and SY2b (AI prediction-with-explanation as First-Look).
Within Block Y2, the order of SY2a and SY2b is randomized.
Then readers complete Block X (Unaided) on their assigned subset SX.
For each reader, SX, SY1a, SY1b, SY2a, and SY2b are disjoint.
|
|
Aktiv komparator: AI as First-Look Review First, Then AI as Double-Check, Then Unaided Review.
Readers first complete Block Y2 (AI as First-Look) on two separate subsets: SY2a (AI prediction-only as First-Look) and SY2b (AI prediction-with-explanation as First-Look).
Within Block Y2, the order of SY2a and SY2b is randomized.
They then complete Block Y1 (AI as Double-Check) on two separate subsets: SY1a (AI prediction-only as Double-Check) and SY1b (AI prediction-with-explanation as Double-Check).
Within Block Y1, the order of SY1a and SY1b is randomized.
Then readers complete Block X (Unaided) on their assigned subset SX.
For each reader, each of the five subsets (SX, SY1a, SY1b, SY2a, and SY2b) comprises up to 80 slides: up to 40 slides from LUAD-LUSC and up to 40 slides from KIRP-KIRC.
|
Readers first complete Block Y2 (AI as First-Look) on two separate subsets: SY2a (AI prediction-only as First-Look) and SY2b (AI prediction-with-explanation as First-Look).
Within Block Y2, the order of SY2a and SY2b is randomized.
They then complete Block Y1 (AI as Double-Check) on two separate subsets: SY1a (AI prediction-only as Double-Check) and SY1b (AI prediction-with-explanation as Double-Check).
Within Block Y1, the order of SY1a and SY1b is randomized.
Then readers complete Block X (Unaided) on their assigned subset SX.
For each reader, SX, SY1a, SY1b, SY2a, and SY2b are disjoint.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Diagnostic performance of cancers
Tidsram: Periprocedural (at the time of slide review)
|
Performance of clinicians (unaided and AI-assisted) for distinguishing LUAD- LUSC and distinguishing KIRP-KIRC, measured in accuracy, sensitivity, specificity, positive predictive value, negative predictive value, and F1.
|
Periprocedural (at the time of slide review)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Diagnos tid
Tidsram: Periprocedural (vid tidpunkten för glidöversikt)
|
Genomsnittlig tid (sekunder per fall) krävs för att slutföra en diagnos.
|
Periprocedural (vid tidpunkten för glidöversikt)
|
|
Interobservatörsvariabilitet
Tidsram: Periprocedural (vid tidpunkten för glidöversikt)
|
Avtal mellan kliniker över förhållanden, mätt med hjälp av mätvärden mellan rater (t.ex. Kappa-statistik).
|
Periprocedural (vid tidpunkten för glidöversikt)
|
|
Nettoförmån efter AI -exponering
Tidsram: Periprocedural (vid tidpunkten för glidöversikt)
|
Den övergripande förändringen i diagnostisk noggrannhet som kan hänföras till AI -hjälp.
|
Periprocedural (vid tidpunkten för glidöversikt)
|
|
Clinician confidence level
Tidsram: Periprocedural (at the time of slide review)
|
Self-reported diagnostic confidence recorded for each case.
Scale: 5 - Absolutely Certain; 4 - Mostly Certain; 3 - Unsure; 2 - Very Doubtful; 1 - Random Guess; With 5 being the highest confidence score and 1 being the lowest.
|
Periprocedural (at the time of slide review)
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ENLIGHT Study
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .