CT-guided Percutaneous Radionuclide Therapy With 32P Microparticles in Patients With Non-progressive Locally Advanced Pancreatic Cancer (PANCOSIL)
Safety and Feasibility of CT-guided Percutaneous Radionuclide Therapy With 32P Microparticles in Patients With Non-progressive Locally Advanced Pancreatic Cancer (PANCOSIL): an Open-label, Single-arm Phase 1-2 Feasibility Study
Pancreatic ductal adenocarcinoma is a highly lethal cancer, and approximately 40% of patients present with non-metastatic locally advanced pancreatic cancer (LAPC) that is not suitable for surgical resection. To improve outcomes in this patient group, local ablative treatments are being explored. Radionuclide therapy (RNT) is a promising option that delivers high-dose internal radiation directly into the tumor, potentially achieving better local tumor control while sparing surrounding tissues compared with external-beam radiation therapy. The OncoSil™ device is a type of RNT containing Phosphorus-32-radiolabeled microparticles. The ³²P microparticles have been designed to deliver a localized distribution of beta-radiation within the target tumor up to 100 Gy, which causes direct damage to cancer cell DNA and renders them incapable of further cell division and proliferation. Favorable results have been reported by implanting ³²P microparticles intra-tumorally, which is typically administered via endoscopic ultrasound guidance. A percutaneous approach may allow for more precise and reproducible delivery, but prospective data on its safety and feasibility are lacking.
This prospective, single-arm phase 1-2 feasibility study aims to evaluate the safety and feasibility of percutaneous CT- guided RNT using ³²P microparticles in patients with non-progressive LAPC following induction chemotherapy. Twenty adult patients with pathology-confirmed LAPC, showing non-progressive disease according to RECIST, will be included after multidisciplinary tumor board review. Patients will undergo percutaneous, CT-guided implantation of ³²P microparticles under general anesthesia, sedation, or local analgesia depending on study phase and clinical judgment, followed by continuation of standard systemic chemotherapy and routine follow-up.
The primary endpoint is the rate of adverse events (CTCAE grade ≥3) occurring during the procedure and within 90 days afterward. Secondary endpoints include technical success, all adverse events, best overall respons, overall and progression-free survival, and changes in tumor markers.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 2
- Фаза 1
Контакты и местонахождение
Контакты исследования
- Имя: Danielle J.W. Vos
- Номер телефона: +31204444571
- Электронная почта: d.vos@amsterdamumc.nl
Места учебы
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North Holland
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Amsterdam, North Holland, Нидерланды, 1081 HV
- Рекрутинг
- Amsterdam UMC - location VUmc
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Контакт:
- Danielle J.W. Vos
- Номер телефона: +3120-4444571
- Электронная почта: interventieradiologie@amsterdamumc.nl
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Age ≥18 years
- Locally advanced pancreatic cancer, defined by the DPCG consensus criteria as: arterial involvement >90 degrees or venous involvement >270 degrees.
- At least RECIST stable disease after a minimum two months of chemotherapy according to current clinical practice*
- Capable of providing written and oral informed consent
- Candidate for RNT, judged by a multidisciplinary tumor board
- WHO 0-2
Exclusion Criteria:
- Eligibility for resection
- Participation in other trials focussing on different ablative treatment modalities such as radiofrequency ablation or irreversible electroporation for LAPC
- Known hypersensitivity to silicon or phosphor
- Bleeding disorders which cannot be corrected with medication
- Inability/unwillingness to interrupt anticoagulation therapy
- Pregnancy
- Metastatic pancreatic cancer
- Epilepsy episode(s) in the past six months
- Longest tumor diameter >70 mm or total target tumor volume >110 ml
- Presence of multiple collateral vessels surrounding or adjacent to the target tumor on radiologic imagining, prohibiting safe injection of the OncosilTM device
- Presence (or significant risk) of varices near the target tumor on radiologic imaging
- Recent clinically significant pancreatitis
- Previous administration of radiotherapy to the pancreas
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: CT-guided percutaneous intratumoural implantation of ³²P microparticles for LAPC
CT-guided percutaneous intratumoural implantation of the OncoSil™ device, containing ³²P microparticles as a form of radionucleide therapy for 20 patients diagnosed with RECIST-stable LAPC after 2 months of systemic therapy.
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CT-guided percutaneous intratumoural implantation of the OncoSil™ device, containing ³²P microparticles as a form of radionucleide therapy for 20 patients diagnosed with RECIST-stable LAPC after 2 months of systemic therapy.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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Safety defined as the rate of procedure- or device-related CTCAE grade ≥3 adverse events (AEs) within 90 days after implantion.
Временное ограничение: From implantation to 90 days after implantation
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From implantation to 90 days after implantation
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Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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Technical succes defined a the rate of adequate punctures and subsequent complete intratumoral delivery of the planned dose.
Временное ограничение: Periprocedural.
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Periprocedural.
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Overall safety defined as the rate of adverse events.
Временное ограничение: From implantation until 90 days after implantation.
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From implantation until 90 days after implantation.
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Duration of implantation procedure defined as the total time of punction.
Временное ограничение: Periprocedural.
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Periprocedural.
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Duration of overall procedure defined as the total time in the radiology suite.
Временное ограничение: Periprocedural.
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Periprocedural.
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Overall survival
Временное ограничение: Defined from diagnosis and from implantion untill death by any cause, assessed up to end of study or up to 1 year after implantation.
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Defined from diagnosis and from implantion untill death by any cause, assessed up to end of study or up to 1 year after implantation.
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Local, distant and overall progression free survival
Временное ограничение: Defined from diagnosis and from implantation until local and/or distant progression, or death, assessed up to end of study or up to 1 year after implantation.
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Defined from diagnosis and from implantation until local and/or distant progression, or death, assessed up to end of study or up to 1 year after implantation.
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Changes in serum CA19.9 during the first three months after implantation.
Временное ограничение: From implantation until three months after implantation.
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From implantation until three months after implantation.
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Visual confirmation of intra-tumoral delivery of ³²P microparticles or other off-target deposition.
Временное ограничение: SPECT-imaging at +4 hours and +7 days after implantation.
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SPECT-imaging at +4 hours and +7 days after implantation.
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
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
- NL78596.000.22
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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