Comparison of I-124 PET/CT for the Diagnosis of Thyroid Cancer
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: Iodine-124, Positron Emission Tomography (PET)/Computerized tomography (CT).
- Кому может быть актуально
- Состояния в реестре: Thyroid Cancer. Базовые параметры: от 13 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
- США
- 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
Comparison of I-124 PET/CT to I-123 Whole Body Imaging for the Diagnosis of Thyroid
Обзор
Persons diagnosed with thyroid cancer are often treated initially with a thyroidectomy, which is followed by ablation using Iodine-131, a therapy which has been shown to be effective and safe. Imaging of metastatic thyroid cancer has been performed with whole body I-131 and Iodine 123 (I-123) imaging for many decades and use I-123 for staging studies. Iodine 124 (I-124) is a radioisotope of iodine which emits a positron and is imaged using PET (positron emission tomography). This is a single arm prospective trial that evaluates the ability of Iodine-124 (I-124) to detect metastatic thyroid cancer compared to non-interventional, usual care I-123 and I-131 images.
Подробное описание
PRIMARY OBJECTIVES:
1\) Agreement between 1-124 PET and 1-123/1-131 SPECT.
SECONDARY OBJECTIVES:
1. Sensitivity and specificity of I-124 PET to detect metastatic thyroid cancer compared to composite standard. 2. Reclassification rate of I-124 PET compared to I-123 SPECT. 3. Inter-reader variability for I-124 PET and I-123 SPECT. 4. Safety of I-124 PET. 5. Participant level detection rate for I-124 in the overall population. 6. Participant level detection rate for I-124 in participants who have negative I-123 SPECT. 7. Comparison of lesion detection between I-124 PET and 24 hour I-123 SPECT. 8. Comparison of lesion detection between I-124 PET and post-treatment I-131 SPECT.
EXPLORATORY OBJECTIVES:
1\. Ability to predict lesion absorbed dose using I-124 PET/CT.
OUTLINE:
All participants will have a single PET/CT scan after administration of I-124 and will be followed for up to 3-5 days by phone for evaluation of adverse events. A subset of participants being evaluated for dosimetry will be imaged up to two additional times over five days after administration. Data from other scans for comparison will be obtained from the participant's medical record.
Вмешательства
- Препарат Iodine-124
Given Orally - Процедура Positron Emission Tomography (PET)/Computerized tomography (CT)
Combination of PET and CT imaging
Первичные конечные точки
- Proportion of agreement between I-124 PET and I-123/I-131 SPECT (participant) [Срок оценки: 1 day]
- Number of agreement between 1-124 PET and 1-123/1-131 SPECT (region) [Срок оценки: 1 day]
Вторичные конечные точки (12)
- Overall specificity of I-124 PET for detection of metastatic thyroid cancer (participant) [Срок оценки: 1 day]
- Overall specificity of I-124 PET for detection of metastatic thyroid cancer (region) [Срок оценки: 1 day]
- Overall sensitivity of I-124 PET for detection of metastatic thyroid cancer (participant) [Срок оценки: 1 day]
- Overall sensitivity of I-124 PET for detection of metastatic thyroid cancer (region) [Срок оценки: 1 day]
- Reclassification Rate [Срок оценки: 1 day]
- Proportion of participants with treatment-related adverse events [Срок оценки: Up to 5 days]
- Proportion of participants with positive I-124 PET in the overall population [Срок оценки: 1 day]
- Proportion of participants with positive I-124 PET in participants who have negative I-123 SPECT [Срок оценки: 1 day]
- Mean of total number of lesions characterized as positive on I-124 PET and 24 hour I-123 SPECT [Срок оценки: 1 day]
- Mean of total number of lesions characterized as positive on both I-124 PET and 7-day post I-131 [Срок оценки: 1 day]
- Inter-reader reliability (IRR) for I-124 PET (region) [Срок оценки: 1 day]
- Inter-reader reliability (IRR) for I-124 PET (participant) [Срок оценки: 1 day]
Критерии участия
Критерии включения
- Age >= 13 years.
- Histopathologically confirmed differentiated or poorly differentiated thyroid cancer.
- Meeting criteria for one of the following two populations:
- American Thyroid Association (ATA) intermediate or high-risk thyroid cancer and planning on treatment using I-131.
- Metastatic disease on imaging (CT, MRI, ultrasound or FDG PET), and considering localized therapy such as surgery and radiation therapy.
- Undergone total thyroidectomy.
- Planned I-123 imaging within 45 days after enrollment.
- Ability to understand a written informed consent document, and the willingness to sign it.
Критерии исключения
- Unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
- Known pregnancy.
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
- Диагностика
Центры проведения
США · 1 центр
- University of California, San Francisco — San Francisco
Идентификаторы
NCT: NCT06961084 · 249212 · NCI-2025-03041