Hypersight and Ethos In Pediatric Radiotherapy

Официальное название

Hypersight and Ethos In Pediatric Radiotherapy (Peds Ethos)

Обзор

This is a single-center, prospective pilot study evaluating the utility of HyperSight CBCT imaging and Ethos adaptive radiation planning in pediatric patients receiving radiation therapy for non-cranial tumors. Twenty patients aged 18 or under will be enrolled. Participants will receive standard-of-care radiation therapy, with the addition of twice-weekly HyperSight CBCT scans. These scans will be used to assess anatomical changes and generate adapted radiation plans using the Ethos platform. Radiation oncologists and radiation therapists will independently evaluate the need for adaptation, and adapted vs. scheduled plans will be compared using dosimetric and anatomical similarity metrics. An optional sub-study will allow anonymized imaging and planning data to be shared with Varian Medical Systems. The study duration will match the patient's treatment course, typically 1-6 weeks, with no additional follow-up beyond standard care.

Вмешательства

• Устройство HyperSight CBCT scans
  During the standard of care pediatric radiation treatment, a Cone Beam Computed Tomography (CBCT) image is taken after the patient is positioned on the radiation treatment table. This image, captured using equipment built into the treatment machine, helps ensure accurate alignment and allows assessment of tumor or tissue changes.

Первичные конечные точки

• Dice Similarity Coefficient [Срок оценки: From baseline (start of radiation treatment) to end of treatment, approximately 6 to 8 weeks.]
• Hausdorff distance [Срок оценки: From baseline (start of radiation treatment) to end of treatment, approximately 6 to 8 weeks.]
• Volume differences [Срок оценки: Time Frame: From baseline (start of radiation treatment) to end of treatment, approximately 6 to 8 weeks.]

Вторичные конечные точки (8)

• Quality of cone beam CT [Срок оценки: From baseline to end of treatment (approximately 6 to 8 weeks)]
• Organ motion [Срок оценки: From baseline to end of treatment (approximately 6 to 8 weeks)]
• Feasibility of Conformal Planning in Traditionally Field-Based Diseases [Срок оценки: From baseline to end of treatment (approximately 6 to 8 weeks)]
• Feasibility of Conformal Planning in Traditionally Field-Based Diseases [Срок оценки: From baseline to end of treatment (approximately 6 to 8 weeks)]
• Feasibility of Conformal Planning in Traditionally Field-Based Diseases [Срок оценки: From baseline to end of treatment (approximately 6 to 8 weeks)]
• Dosimetric Impact of Adaptive Radiation Therapy [Срок оценки: From baseline to end of treatment (approximately 6 to 8 weeks)]
• Safety of Minimized Target Expansion Volumes [Срок оценки: From baseline to end of treatment (approximately 6 to 8 weeks)]
• Integration of Radiation Therapy Proficiencies in Adaptive Planning [Срок оценки: From baseline to end of treatment (approximately 6 to 8 weeks)]

Критерии участия

Критерии включения

• Patient (paediatric or adolescent) age 18 or under receiving at least 5 days of radiation therapy
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3

Критерии исключения

\- Patients with primary cranial tumours will be excluded due to the low expected utility of non-contrast CT scans in the delineation of brain edema and brain substructures.

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

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Princess Margaret Cancer Centre — Toronto

Идентификаторы

NCT: NCT07528547 · 25-5372

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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