AI-Augmented Diagnostic Assessment With ENLIGHT Versus Independent Pathologist Review | NCT07741058

NCT07741058

Overview

NCT ID: NCT07741058
Lead Sponsor: Harvard Medical School (HMS and HSDM)OTHER
Official Title: AI-Augmented Diagnostic Assessment With ENLIGHT Versus Independent Pathologist Review
Brief Summary: 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.

Status and Timeline

Status: Enrolling by invitation
Last Update Posted: Aug 3, 2026Actual
Start Date: Jul 2026Estimated
Primary Completion Date: Aug 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 25Estimated
Primary Purpose: Diagnostic
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Quadruple

Contacts and Locations

Central Contacts: No data available
Locations: Harvard Medical School,

Similar Studies

Participant Group/Arms

Unaided Review First, Then AI as Double-Check, Then AI as First-Look.Active Comparator

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.

Behavioral: Unaided Review First, Then AI as Double-Check, Then AI as First-Look.

Unaided Review First, Then AI as First-Look, Then AI as Double-Check.Active Comparator

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.

Behavioral: Unaided Review First, Then AI as First-Look, Then AI as Double-Check.

AI as Double-Check Review First, Then AI as First-Look, Then Unaided Review.Active Comparator

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.

Behavioral: AI as Double-Check First, Then AI as First-Look, Then Unaided Review.

AI as First-Look Review First, Then AI as Double-Check, Then Unaided Review.Active Comparator

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.

Behavioral: AI as First-Look First, Then AI as Double-Check, Then Unaided Review.