Идёт набор NCT06546592

Locally Optimised Contouring With AI Technology for Radiotherapy

Без фазы С лечением Contouring Segmentation Radiation Therapy Artificial Intelligence

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: В протоколе указаны: AI assisted contouring.
Кому может быть актуально: Состояния в реестре: Contouring, Segmentation, Radiation Therapy, Artificial Intelligence. 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: Австралия
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

LOCATOR - Locally Optimised Contouring With AI Technology for Radiotherapy

Обзор

LOCATOR is a multicentre phase II randomised clinical trial that is looking at the process of contouring in radiation treatment for breast cancer patients. This study looks at whether contouring aided by artificial intelligence (AI) is comparable in quality to that of contouring done completely manually by a radiation oncologist. We are also looking at whether AI assisted contouring saves radiation oncologists time when compared to fully manual contouring. LOCATOR uses the LOCATOR software which is an in-house software developed locally and trained on local data.

Подробное описание

LOCATOR is a multicentre phase II non-inferiority randomised controlled trial looking at comparing AI assisted contours (with in-house LOCATOR software) against fully manual contouring in breast cancer patients. The primary endpoint is to show non inferiority in grade of AI assisted contouring when compared to fully manual contouring with a poor contour (score \<= 2) as per the MD Anderson Contouring Grade Scale. Secondary endpoints include geometric assessments of contour accuracy, dosimetric differences based on contours, performance (geometric) when compared to commercially available tools as well as economic cost-benefit analysis if in-house AI contouring tools.

The study will randomise patients 3:1 to the intervention arm of LOCATOR assisted contours to manual contours. An initial AI contouring model for each tumor type will be trained on contours from 45 previous breast cases using a nnUNetv2 framework. The model will then be iteratively updated every 20-50 patients.

Вмешательства

Устройство AI assisted contouring
Initial are generated automatically using software powered by artificial intelligence

Первичные конечные точки

Assessment of differences in Contour Quality [Срок оценки: 18 months]

Вторичные конечные точки (12)

Assessment of quality of AI assisted contours with and without manual edits [Срок оценки: 18 months]
Time Savings [Срок оценки: 18 months]
To assess the differences in acute clinician reported toxicity between patients treated with contours assisted by AI contouring versus manual contouring. [Срок оценки: 18 months]
To assess the differences in late clinician reported toxicity between patients treated with contours assisted by AI contouring versus manual contouring. [Срок оценки: 5 years]
To assess the differences in patient reported general acute quality of life outcomes between patients treated with contours assisted by AI contouring versus manual contouring. [Срок оценки: 18 months]
To assess the differences in patient reported general late quality of life outcomes between patients treated with contours assisted by AI contouring versus manual contouring. [Срок оценки: 5 years]
To assess the differences in patient reported breast specific acute quality of life outcomes between patients treated with contours assisted by AI contouring versus manual contouring. [Срок оценки: 18 months]
To assess the differences in patient reported breast specific late quality of life outcomes between patients treated with contours assisted by AI contouring versus manual contouring. [Срок оценки: 5 years]
Assessment of accuracy of AI assisted contours before and after manual edits using surface dice similarity coefficient (sDSC). [Срок оценки: 18 months]
Assessment of accuracy of AI assisted contours before and after manual edits using dice similarity coefficient (DSC). [Срок оценки: 18 months]
Assessment of accuracy of AI assisted contours before and after manual edits using added path length (APL) [Срок оценки: 18 months]
Assessment of accuracy of AI assisted contours before and after manual edits using mean slice-wise Hausdorff distance (MSHD). [Срок оценки: 18 months]

Критерии участия

Критерии включения

18 years and older who are planned for primary breast malignancy
ECOG performance 0-2
Ability to understand and willingness to sign a written informed consent document
The target volume must be able to be objectively reviewed by current published national or international clinical guidelines