The Safety and Feasibility of Radiofrequency Ablation to Treat Low-risk 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: Radiofrequency ablation.
- Кому может быть актуально
- Состояния в реестре: Thyroid Nodule, Thyroid Cancer. Базовые параметры: 18 лет — 100 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
- Канада
- 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
Thermo-Ablation With Radiofrequency Medical Technologies to Treat Thyroid Cancers
Обзор
The goal of this clinical trial is to test radiofrequency ablation (RFA) in thyroid cancers ≤2 cm in diameter. The main question it aims to answer is: • What is the feasibility of RFA use for low-risk thyroid cancers (≤2 cm)? Participants will undergo a set of pre-procedural scans of the target thyroid nodule and undergo the RFA procedure/intervention. Then, participants will partake in three follow-up appointments at 4 weeks, 6 months, and 12 months post-procedure as per standard of care.
Подробное описание
This is a single center, prospective case series designed to assess the feasibility of RFA therapy (using an investigational RFA device) in a small cohort of participants at University Health Network Toronto. We hypothesize that it will be safe and feasible to use RFA therapy at the University Health Network, Toronto. Further, we believe participants will maintain a good quality of life in the postoperative period, including most avoiding hypothyroidism.
Patients will follow the standard clinical work-up to undergo surgery (e.g. lab parameters and preoperative scans). Patients will - after written informed consent - undergo the RFA procedure.
Within the first year there will be three follow-ups with the participants at:
* 4 weeks * 6 months * 12 months post-procedure. After the 12-month follow-up, participants will have follow-up appointments every 6 months until the end of the study.
During these follow-up appointments, the clinician will note any complications or adverse events, and participants will undergo blood sample draws to evaluate serum thyroid stimulating hormone (TSH) concentration. Thyroid nodule size is captured at each follow-up post-procedure via ultrasound, and a re-biopsy may be performed after 12 months to determine if there is material change in the cellular type of the thyroid nodule.
Cost of RFA treatment (probes, human resources, clinic time, complications) compared to traditional thyroidectomy (instruments, human resources, operating room time, hospital stay, complications) will also be compared to historical controls for thyroidectomy costs based on past literature to evaluate the feasibility of RFA as an intervention in this population.
Patients will be given a questionnaire at baseline and post-RFA (\~7-9 months) which includes the following components:
* thyroid cancer treatment status; * the Decision Regret Scale (0 to 100) where 100 represents maximal regret (only post-RFA); * the Fear of Progression Questionnaire- Short Form questionnaire (focused on thyroid cancer disease progression); * the Hospital Anxiety and Depression Scale (HADS); * the MD Anderson Symptom Inventory for thyroid cancer (MDASI-Thy), a disease-specific quality of life questionnaire; and * the Body Image Scale (BIS), a questionnaire on body image perception for cancer patients.
Вмешательства
- Процедура Radiofrequency ablation
Radiofrequency energy is delivered to the thyroid nodule via the medical device. This device is a system consisting of 3 main components: 1. VIVA combo RF system (generator and pump) 2. single foot switch 3. electrode (5mm, 7mm, 10mm, or adjustable).
Первичные конечные точки
- Complications [Срок оценки: Immediately after the procedure, and 4 weeks/6 months/12 months post-procedure.]
Вторичные конечные точки (7)
- Effectiveness [Срок оценки: 4 weeks/6 months/12 months post-procedure.]
- Effectiveness [Срок оценки: 4 weeks/6 months/12 months post-procedure.]
- Effectiveness [Срок оценки: 4 weeks/6 months/12 months post-procedure.]
- Quality of life [Срок оценки: 7-9 months post-procedure.]
- Quality of life [Срок оценки: 7-9 months post-procedure.]
- Quality of life [Срок оценки: 7-9 months post-procedure.]
- Quality of life [Срок оценки: 7-9 months post-procedure.]
Критерии участия
Критерии включения
1\. Patients with:
- Nodule less than or equal to 2cm in size
a. Specifically: Bethesda 5/6
- Their age is ≥18 years and ≤100 years
- Able to provide written consent
- Able to attend required follow-ups as per the protocol
Критерии исключения
- Patients <18 years old
- Pregnant women
- Any concern for invasive or metastatic thyroid cancer
- Previously treated for thyroid cancer
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Канада · 1 центр
- University Health Network — Toronto
Идентификаторы
NCT: NCT06929650 · 21-5788