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Набор скоро начнётся NCT07057830

Generative AI Radiologist's Workstation

Наблюдательное Study Aims to Develop and Validate a Generative AI-assistant Designed to Optimize Radiologists' Workflows and to Evaluate Its Performance

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Study Aims to Develop and Validate a Generative AI-assistant Designed to Optimize Radiologists' Workflows and to Evaluate Its Performance. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Россия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Advanced AI-powered Workstation for Radiologists Based on Generative Artificial Intelligence

Обзор

This study aims to develop a generative AI assistant for radiologists to automate the processing of electronic medical records (EMRs) and provide relevant clinical information, optimizing diagnostic interpretation workflows.

Подробное описание

This study aims to develop and validate a generative AI-assistant designed to optimize radiologists' workflow by automatically processing electronic medical records (EMRs) and generating structured clinical summaries. The AI tool will extract and prioritize relevant patient data to support accurate and efficient interpretation of diagnostic imaging studies.

The study rationale originates from increasing radiology workloads and the need to reduce time spent reviewing EMRs while maintaining diagnostic accuracy. The proposed AI solution specifically targets these issues through advanced natural language processing capabilities, with particular attention to optimizing time efficiency while maintaining or improving diagnostic accuracy.

The study consists of 9 Stages:

Stage 1: Theoretical Foundation.

1.1 Systematic review: comprehensive analysis of existing LLM applications in radiology.

1.2 Healthcare system analysis: evaluation of LLM implementations in clinical settings.

1.3 Expert consensus: semi-structured interviews with 30 practicing radiologists (stratified by experience: junior \[\<3 years\], mid-career \[3-10 years\], senior \[\>10 years\]) to establish:

* Minimum required clinical data elements; * Optimal summary format (structured vs. narrative); * Critical alert thresholds.

Stage 2: Technical Development.

2.1 Medical text processing: formalization of methods for extraction, standardization, and annotation.

2.2 Dataset Curation: methodology for creating representative training datasets from UMIAS (Unified Medical Information and Analytical System).

2.3 Validation Framework: creation of validation methodology for the generative AI-based assistant.

Development and validation of a questionnaire assessing:

* Relevance; * Completeness (missing critical data); * Hallucination frequency; * Terminology/grammar; * Radiologist satisfaction.

Stage 3: Dataset Development.

Data Source: Retrospective extraction of anonymized EMRs from UMIAS.

Inclusion Criteria:

* Age of the patient at the moment of medical image acquisition \>18 years; * Pathology types: pleuritis, ascites, unspecified masses/lesions, neuropathy; * Imaging study modalities (performed between January 1, 2020, and May 31, 2025): CT chest (pleural/pulmonary pathologies); CT abdomen/pelvis (ascites/abdominal masses); MRI brain (neuropathy/neurological conditions); * Complete EMR data (clinical notes, prior imaging reports, lab results, discharge summaries).

Exclusion Criteria:

Cases with technical artifacts on medical images compromising diagnostic quality.

Per-case data collected: physical examination results; two prior imaging reports (same modality) for progression assessment; three laboratory test results; consultation notes from three clinical specialists; discharge summaries; AI-Generated summaries (three summaries of different quality), including:

* High quality summary: complete, well-structured, clinically relevant; * Medium quality summary: partial omissions, acceptable structure; * Low quality summary: significant omissions/poor structure.

Stage 4: Comparative analysis of open-license generative AI architectures.

Stage 5: Model selection according to pre-defined selection criteria.

Stage 6: Model adaptation (fine-tuning and prompt optimization).

Stage 7: Development and UMIAS integration of a minimum viable product (MVP).

Stage 8: Pilot Testing.

Participants: 27 radiologists divided into three groups (A, B and C; n=9 each). Detailed description of each group is in section 'Groups and Interventions'. The group B will evaluate AI-summary quality via specially developed and validated questionnaire (scores: ≤8=low, 9-15=medium, \>15=high).

In the end of pilot testing primary and secondary outcomes will be assessed.

Stage 9: Comparative analysis across all groups. Formulation of conclusions and assessment of the AI-assistant's applicability.

Первичные конечные точки

  • Radiologist satisfaction levels [Срок оценки: 6 months]
Вторичные конечные точки (3)
  • Change in time required for medical record analysis [Срок оценки: 6 months]
  • Change in study interpretation time [Срок оценки: 6 months]
  • Change in the number of reporting errors [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Board-certified practicing radiologist;
  • ≥3 years of experience in diagnostic imaging;
  • Proficiency in using UMIAS systems;
  • Signed informed consent form.

Критерии исключения

  • Participation in other studies;
  • Unwillingness to adopt new technologies in daily practice;
  • Conflict of interest.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Россия · 2 центра
  • MIREA - Russian Technological University — Moscow
  • Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of th — Moscow

Публикации

  • Borisov A, Burtsev T, Kosov P, Bobrovskaya T, Vasilev Y, Vladzymyrskyy A, Omelyanskaya O, Pamova A, Arzamasov K. Key aspects of fine-tuning and applying LLM-as-a-judge for clinical data summaries in the radiological workflow. Front Artif Intell. 2026 Mar 19;9:1768005. doi: 10.3389/frai.2026.1768005. eCollection 2026. PMID 41940108

Идентификаторы

NCT: NCT07057830 · 2025-2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗