An observational study in Upper Aerodigestive Tract Neoplasms, Upper AerodigestiveTract Cancer and Upper Aero-digestive Tract (UADT) Neoplasm, sponsored by Istituto Italiano di Tecnologia. Not yet recruiting at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by Istituto Italiano di Tecnologia · Observational
This is a prospective observational clinical study designed to evaluate the performance of artificial intelligence (AI) algorithms applied to upper aerodigestive tract (UADT) video-endoscopy. The study assesses three main tasks: lesion detection (localization), classification (benign vs malignant), and segmentation of tumor margins.
AI algorithms will be applied to endoscopic video data acquired during routine clinical practice without influencing clinical decision-making. The system will process images in real time and store data for subsequent analysis. AI outputs will be compared with physician assessment and reference standard histopathology to evaluate diagnostic performance.
The artificial intelligence algorithms developed will be employed in the analysis of laryngeal lesions for 3 tasks:
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's planned enrollment of 283 is above the median of 100 across 502 observational studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Istituto Italiano di Tecnologia is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The sample size for a single-arm, prospective cohort study, where the same group of patients undergoes testing with an AI model and a human physician and then they are compared with the gold standard reference test (biopsy) was calculated based on information from previous studies
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Negative Predictive Value of the CADx Algorithm for Malignant or Premalignant Upper Aerodigestive Tract Lesions
Negative Predictive Value (NPV) of the computer-aided diagnosis (CADx) algorithm for classifying UADT lesions as malignant/premalignant versus benign/non-neoplastic, using definitive histopathology as the reference standard. The CADx final classification will be based on the majority rule across selected white-light and narrow-band imaging frames. NPV = true negatives / (true negatives + false negatives). The pre-specified performance target is NPV ≥ 90%.
Time frame: From index outpatient UADT video-endoscopy until definitive histopathology result is available, assessed up to 60 days after endoscopy.
Sensitivity of the CADe Algorithm for Localization of Upper Aerodigestive Tract Lesions
Sensitivity of the computer-aided detection (CADe) algorithm for localizing UADT lesions with a bounding box. A true positive is defined as localization of the lesion area by a bounding box in the majority of physician-labeled lesion-positive captured frames. Sensitivity = true positives / (true positives + false negatives).
Time frame: At index outpatient UADT video-endoscopy, with blinded post-processing assessment performed up to 30 days after endoscopy.
Median Intersection Over Union Between CASe Segmentation and Surgeon-Drawn Lesion Margins
Median overlap between the AI-generated segmentation mask and the lesion margin area drawn by the surgeon on intraoperative endoscopic images. Intersection over Union (IoU) = area of overlap / area of union. Values range from 0 to 1; higher values indicate greater agreement.
Time frame: At intraoperative pre-resection endoscopy, with assessment performed after image annotation up to 30 days after surgery.
Median Dice Similarity Coefficient Between CASe Segmentation and Surgeon-Drawn Lesion Margins
Median Dice Similarity Coefficient (DSC) between the AI-generated segmentation mask and the lesion margin area drawn by the surgeon on intraoperative endoscopic images. Dice Similarity Coefficient = 2 × area of overlap / (AI segmented area + surgeon-drawn area). Values range from 0 to 1; higher values indicate greater agreement.
Time frame: At intraoperative pre-resection endoscopy, with assessment performed after image annotation up to 30 days after surgery.
WL-NPV vs. NBI-NPV of CADx classification
Negative Predictive Value (NPV) of CADx classification calculated using only the three selected white-light frames, compared with definitive histopathology, vs. NPV of CADx classification calculated using only the three selected narrow-band imaging frames, compared with definitive histopathology. The final AI-result will be calculated based on the majority rule of the 3 WL and 3 NBI frames computed separately.
Time frame: From index outpatient UADT video-endoscopy until definitive histopathology result is available, assessed up to 60 days after endoscopy.
Clinician-Reported Usability Score for the AI Endoscopy System
Usability of the AI endoscopy system assessed using standardized usability questionnaires administered to clinicians after use of the AI system. Questionnaire scoring will be interpreted according to the selected questionnaire manual, with higher scores indicating greater usability.
Time frame: Assessed after clinician use of the AI system during study procedures, up to 20 months after study initiation.
Sensitivity, Specificity and Accuracy of CADx histology prediction
Sensitivity, Specificity and Accuracy of the CADx algorithm for histology prediction, compared with definitive histopathology.
Time frame: From index outpatient UADT video-endoscopy until definitive histopathology result is available, assessed up to 60 days after endoscopy.
F1 Score of CADx Classification
F1 score of the CADx classification output compared with definitive histopathology.
Time frame: From index outpatient UADT video-endoscopy until definitive histopathology result is available, assessed up to 60 days after endoscopy.
Area Under the Receiver Operating Characteristic Curve of CADx Classification
AUC of the ROC curve for CADx classification of UADT lesions compared with definitive histopathology.
Time frame: From index outpatient UADT video-endoscopy until definitive histopathology result is available, assessed up to 60 days after endoscopy.
Sensitivity, Specificity and Accuracy of human physician histology prediction
Sensitivity, Specificity an Accuracy of the treating physician's suspected diagnosis compared with definitive histopathology.
Time frame: From index outpatient UADT video-endoscopy until definitive histopathology result is available, assessed up to 60 days after endoscopy.
Specificity of the CADe Algorithm for Localization of Upper Aerodigestive Tract Lesions
Proportion of physician-labeled lesion-negative frames/cases in which the CADe algorithm does not output a bounding box in the majority of negative-control frames.
Time frame: At index outpatient UADT video-endoscopy, with blinded post-processing assessment performed up to 30 days after endoscopy.
Accuracy of the CADe Algorithm for Localization of Upper Aerodigestive Tract Lesions
Overall proportion of correctly classified lesion-positive and lesion-negative cases/frames by the CADe algorithm.
Time frame: At index outpatient UADT video-endoscopy, with blinded post-processing assessment performed up to 30 days after endoscopy.
Positive Predictive Value of the CADe Algorithm for Localization of Upper Aerodigestive Tract Lesions
Positive predictive value of CADe bounding-box output for lesion localization. PPV = true positives / (true positives + false positives).
Time frame: At index outpatient UADT video-endoscopy, with blinded post-processing assessment performed up to 30 days after endoscopy.
Negative Predictive Value of the CADe Algorithm for Localization of Upper Aerodigestive Tract Lesions
Negative predictive value of CADe absence of bounding-box output for lesion localization. NPV = true negatives / (true negatives + false negatives).
Time frame: At index outpatient UADT video-endoscopy, with blinded post-processing assessment performed up to 30 days after endoscopy.
Percentage of Positive Superficial Margin Cases in Which the AI-Predicted Tumor Area Is Wider Than the Surgeon-Drawn Area
Among cases with positive superficial margins on final histopathology, percentage of cases in which the AI-predicted tumor area extends beyond the surgeon-drawn margin at the affected margin.
Time frame: At intraoperative pre-resection endoscopy, with assessment performed after image annotation up to 30 days after surgery.
Plan to share: Undecided
Start is estimated for May 2026; primary completion for Dec 2027, 19 months later.
Of 215 non-industry observational studies under Head and Neck Neoplasms, half reached primary completion within 71 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 144. This study's planned 19 months is below that.
Counting every sponsor, half of 237 studies reached it within 71 months; a quarter within 29 and three quarters within 142.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Istituto Italiano di Tecnologia