Pilot Study on the Feasibility of High-energy Collimation With Optimized Geometry on a VERITON™ CZT Camera (HELIOS)
Functional imaging using scintigraphy plays a major role in the diagnosis and monitoring of many diseases, particularly thanks to its ability to perform whole-body examinations with high contrast. The indications and use of scintigraphy have increased in recent years, particularly in connection with the development of internal vectorized radiotherapy. This therapeutic approach is based on the administration of radiotracers that enable targeted irradiation of tumor cells, whose biodistribution throughout the body can be analyzed and quantified using scintigraphy, particularly with iodine-131 and lutetium-177.
The recent boom in scintigraphy is also linked to the development of new 360° geometry CZT-SPECT cameras, which enable rapid tomographic acquisitions of the entire body with significantly improved image quality compared to conventional cameras. These systems use mobile CZT semiconductor detectors that dynamically scan the anatomical regions of interest.
CZT detectors are combined with a collimation system consisting of tungsten septa, which are essential for the directional filtering of gamma photons. Unlike conventional scintigraphic cameras, where collimators can be changed or adjusted according to the energy of the detected photons, CZT-SPECT 360° cameras generally rely on fixed collimation, which cannot be changed.
Обзор исследования
Статус
Условия
Подробное описание
Functional imaging using scintigraphy plays a major role in the diagnosis and monitoring of many diseases, particularly thanks to its ability to perform whole-body examinations with high contrast. The indications and use of scintigraphy have increased in recent years, particularly in connection with the development of internal vectorized radiotherapy. This therapeutic approach is based on the administration of radiotracers that enable targeted irradiation of tumor cells, whose biodistribution throughout the body can be analyzed and quantified using scintigraphy, particularly with iodine-131 and lutetium-177.
The recent boom in scintigraphy is also linked to the development of new 360° geometry CZT-SPECT cameras, which enable rapid tomographic acquisitions of the entire body with significantly improved image quality compared to conventional cameras. These systems use mobile CZT semiconductor detectors that dynamically scan the anatomical regions of interest.
CZT detectors are combined with a collimation system consisting of tungsten septa, which are essential for the directional filtering of gamma photons. Unlike conventional scintigraphic cameras, where collimators can be changed or adjusted according to the energy of the detected photons, CZT-SPECT 360° cameras generally rely on fixed collimation, which cannot be changed.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Anne-Sophie Hue Project Manager, MSc
- Номер телефона: +33.3.83.15.34.75
- Электронная почта: a.hue@chru-nancy.fr
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- patients with multiple known lesions (≥ 2 metastases or lesions of other types) who, as part of their clinical management, require either (i) a 99mTc-HDP bone scan, or (ii) a post-therapeutic 177Lu-PSMA scan, or (iii) a post-therapeutic 131I scintigraphy.
- Person who has undergone a preliminary clinical examination appropriate for clinical research.
- Adult subject who has received complete information about the research and has signed the informed consent form.
- General condition, WHO ≤ 2, and ability to remain lying down without moving for nearly an hour.
Exclusion Criteria:
- Subjects with a contraindication, according to the target examination group, to injection of 99mTc-HDP (Technescan HDP, Curium Pharma), 177Lu-PSMA (Pluvicto®, Novartis), or 131I (131I sodium iodide for therapy, Curium Pharma) .
- Subjects covered by Articles L. 1121-5, L. 1121-7, and L1121-8 of the Public Health Code.
- Pregnant women, women in labor, or breastfeeding mothers.
- Subjects subject to legal protection measures (guardianship, curatorship, judicial protection).
- Subjects unable to give their consent.
- Subjects deprived of their liberty by a judicial or administrative decision, persons receiving psychiatric care pursuant to Articles L. 3212-1 and L.3213-1.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Диагностика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: VERITON-CT New
Optimized collimators for the CZT detectors of the VERITON™ 400 wide-field camera (Spectrum Dynamics Medical) enabling better selection of incident photons
|
- Whole-body 3D recording on the VERITON™ 400 camera equipped with conventional collimators for technetium-99m and lutetium-177.
|
|
Активный компаратор: Référence
|
Full-body 3D recording on the VERITON™ 400 camera
Whole-body 2D and cervicothoracic 3D recordings using an Anger camera (SYMBIA camera, Siemens Healthineers) for iodine-131 images.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Feasability of whole-body SPECT/CT imaging with iodine-131 using the optimized collimator
Временное ограничение: 1 month
|
Data analysis obtained with optimized collimator and with conventional collimator
|
1 month
|
|
Perform quantitative analysis of technetium-99m and lutetium-177 with feasability results
Временное ограничение: 1 month
|
Image sharpness improvment
|
1 month
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Overall quality of whole-body CZT acquisitions with iodine-131
Временное ограничение: 1 month
|
For iodine-131, the overall quality of images acquired using the CZT-SPECT camera with the new collimator will be described based on an ordinal score for stellar artifacts (absent, present but not interfering, present and interfering), assessed independently by two experienced readers.
The frequency and severity of artifacts will be reported, as well as their association with the interpretable or non-interpretable nature of the examinations defined in the primary endpoint.
Inter-reader agreement will also be described.
|
1 month
|
|
Quantify the detectability and contrast of lesions visualized on whole-body CZT imaging with iodine-131.
Временное ограничение: 1 month
|
Sharpness, defined as the maximum slope of the intensity profile at the edge of the lesions and the contrast-to-noise ratio
|
1 month
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2026-A00456-45
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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