Prostate MRI Analysis by Radiologists and Artificial Intelligence - Disease Identification and Guided Management
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: AI (Lucida Pi) interpretation, Radiologist interpretation.
- Кому может быть актуально
- Состояния в реестре: Prostate CA. Базовые параметры: от 18 лет · Мужчины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Study Assessing Whether Artificial Intelligence is Non-inferior to Radiologists in the Diagnosis of Clinically Significant Prostate Cancer.
Обзор
Prostate cancer is the most common male cancer in 112 countries and makes up 7% of global cancer cases, and is the second leading cause of cancer-related deaths in men. Normally, men with suspected prostate cancer undergo a prostate MRI, and then a Radiologist would review this scan to identify any suspicious areas for cancer within the prostate. Prostate MRI interpretation, however, is an expert skill with a steep learning curve, and internationally, there is a growing shortage of Radiologists. The PARADIGM trial aims to assess if AI can perform just as well as Radiologists in interpreting prostate MRI scans to identify prostate cancer. Enrolled participants will undergo a prostate MRI, which is the normal method used for investigating suspected prostate cancer. AI and a Radiologist will both interpret the MRI, without knowledge of each other's interpretation. Once both reports have been made, the Radiologist will be asked to produce a third, combined report. If there is a suspicious area in the prostate identified either by AI or the Radiologist, targeted biopsies will be performed. If there are no suspicious areas on the MRI and if you are at low risk of harbouring cancer, which occurs in about 30% of men, then no biopsy will be taken at all.
Подробное описание
Aim: To assess whether artificial intelligence is non-inferior to radiologists in the diagnosis of clinically significant prostate cancer on MRI.
Objectives
Primary
1\. To compare the proportion of men who have clinically significant prostate cancer detected on MRI using AI ± targeted biopsy with radiologists ± targeted biopsy.
Secondary
1. To compare the proportion of men who have clinically insignificant prostate cancer detected on MRI using AI ± targeted biopsy with radiologists ± targeted biopsy. 2. To compare the proportion of men with non-suspicious MRIs for AI vs radiologists. 3. To compare the proportion of men with indeterminately scored MRI as reported by AI vs radiologists. 4. To compare the diagnostic test performance of AI vs radiologist. 5. To compare the additive value of AI when used together with a radiologist interpretation (summative of all identified lesions) compared to a radiologist alone. 6. To compare the additive value of AI when used together with a radiologist interpretation (where the radiologist can interact with the AI system by accepting or rejecting AI-identified lesions) compared to a radiologist alone. 7. To determine the frequency of AI failures. 8. To compare treatment eligibility decisions between AI and Radiologist. 9. To compare the cost-effectiveness of unblinded AI interpreted by the radiologist compared to radiologist alone for prostate cancer detection, and AI alone vs. radiologist alone, and a 3-arm analysis considering all three.
Design:
Prospective, international, within-patient, multi-centre, level-1 evidence trial in participants referred to hospital with a clinical suspicion of prostate cancer.
Вмешательства
- Диагностический тест AI (Lucida Pi) interpretation
AI algorithm that will interpretate the prostate MRI - Диагностический тест Radiologist interpretation
Radiologist will interpret the prostate MRI (as per standard of care)
Первичные конечные точки
- Proportion of men with clinically significant cancer [Срок оценки: When biopsy results available, at an expected average of 30 days post-biopsy]
Вторичные конечные точки (12)
- Proportion of men with clinically insignificant cancer [Срок оценки: When biopsy results available, at an expected average of 30 days post-biopsy]
- Proportion of men with non-suspicious MRIs [Срок оценки: When MRI results available, at an expected average of 30 days post-MRI]
- Proportion of MRIs with indeterminate scores. [Срок оценки: When MRI results available, at an expected average of 30 days post-MRI]
- Agreement between AI and Radiologist in score of suspicion [Срок оценки: When MRI results available, at an expected average of 30 days post-MRI]
- Diagnostic test performance characteristics (AI versus Radiologist) [Срок оценки: When biopsy results available, at an expected average of 30 days post-biopsy]
- Diagnostic test performance characteristics (AI plus Radiologist) [Срок оценки: When biopsy results available, at an expected average of 30 days post-biopsy]
- Diagnostic test performance characteristics (AI-assisted Radiologist) [Срок оценки: When biopsy results available, at an expected average of 30 days post-biopsy]
- Significant cancer detected by peri-lesional biopsies [Срок оценки: When biopsy results available, at an expected average of 30 days post-biopsy]
- Significant cancer detected by systematic biopsies [Срок оценки: When biopsy results available, at an expected average of 30 days post-biopsy]
- Frequency of AI failures [Срок оценки: When MRI results available, at an expected average of 30 days post-MRI]
- Treatment eligibility decisions [Срок оценки: When biopsy results available, at an expected average of 30 days post-biopsy]
- Cost-efffectiveness [Срок оценки: At an expected average of 30 days post-intervention]
Критерии участия
Критерии включения
- Men at least 18 years of age referred with clinical suspicion of prostate cancer
- Serum PSA ≤ 20 ng/mL
- Fit to undergo all procedures listed in the protocol
- Able to provide written informed consent
Критерии исключения
- Prior prostate biopsy
- Prior prostate MRI on a previous encounter\*
- Prior treatment for prostate cancer
- Contraindication to MRI (e.g. claustrophobia, pacemaker)
- Metalwork that would give rise to artefact on MRI (e.g. hip prosthesis, pelvic/spinal metalwork)
- Contraindication to prostate biopsy
- Unfit to undergo any procedures listed in protocol
- An MRI on a previous encounter means a previous prostate MRI which has been seen by a doctor and has been used to inform patient management at the time of the original MRI.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Простое слепое
- Основная цель
- Диагностика
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07647445 · 338739