Идёт набор NCT04090034

Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine Tumors

— Наблюдательное Neuroendocrine Tumors Gastroenteropancreatic Neuroendocrine Tumor

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: Peptide Receptor Radionuclide Therapy.
Кому может быть актуально: Состояния в реестре: Neuroendocrine Tumors, Gastroenteropancreatic Neuroendocrine Tumor. Базовые параметры: от 18 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

Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine

Обзор

The specific aim is of this study is to gain a better understanding of the patient characteristics, treatment responses, survival outcomes, and adverse events associated with PRRT in patients with gastroenteropancreatic primary NETs.

Подробное описание

Neuroendocrine tumors (NETs) make up a large range of malignancies that arise from neuroendocrine cells in multiple organs of the body. Hallet et al conducted a large population-based study that demonstrated that 21% of NET patients presented with metastatic disease and another 38% developed metastases after resection of the primary tumor (Hallet et al., 2015). This burden demonstrates the need for effective systemic therapy for advanced NETs. Options for systemic therapy include peptide receptor radionuclide therapy (PRRT).

A need for more prospective series are needed on treatment responses and survival outcomes related to gastroenteropancreatic primary NETs treated with PRRT was identified. Thus the purpose of this study is to collect clinical data related to treatment of gastroenteropancreatic primary NETs s with PRRT. Clinical data related to patient characteristics, treatment responses and survival outcomes related to the treatment of gastroenteropancreatic primary NETs with PRRT and on adverse events and complications related to PRRT treatment will be collected.

Вмешательства

Процедура Peptide Receptor Radionuclide Therapy
a molecular therapy (also called radioisotope therapy) used to treat a specific type of cancer called neuroendocrine tumors or NETs

Первичные конечные точки

Demographics and other patient data [Срок оценки: 7 years from date of procedure]
Tumor specific data [Срок оценки: 7 years from date of procedure]
Use of somatostatin analogs [Срок оценки: 7 years from date of procedure]
Biomarker data (chromogranin A and pancreastatin) [Срок оценки: 7 years from date of procedure]
Diagnostic imaging findings [Срок оценки: 7 years from date of procedure]
Overall survival (OS) [Срок оценки: 7 years from date of procedure]
Time to progression (TTP) [Срок оценки: 7 years from date of procedure]
Treatment responses and progression [Срок оценки: 7 years from date of procedure]
Response [Срок оценки: 7 years from date of procedure]
Disease progression [Срок оценки: 7 years from date of procedure]

Критерии участия

Критерии включения

> 18 years of age
Diagnosed with gastroenteropancreatic primary NET and has consented to undergo PRRT per the treating physician. Specifically:

Will consider other primaries on a case by case basis if dotatate scan (+) and meet all other criteria.
Metastatic or Locally Advanced AND Inoperable
Clear disease progression on Octreotide over less than 3 years (RECIST 1.1)
Presence of disease within 24 weeks as identified by PET/CT scans with Ga-68 DOTATATE reporting the Krenning score for low-grade NET and/or PET/CT scans with FDG for transformation to high-grade NET
Well differentiated on path - Ki67 < 20%
Octreotide positive on pathology (if not documented, acceptable if PET/CT imaging shows lesions with Ga-68 DOTATATE uptakeLabs: