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Идёт набор NCT04668872

Biopsy After Radioembolization to Identify Changes in Tumor Cells From the Radiation

— Наблюдательное Colon Cancer Liver Metastasis Colon Cancer Adenocarcinoma of the Colon Adenocarcinoma of the Rectum

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: Y90 TARE, PET/CT, PET/MRI.
Кому может быть актуально
Состояния в реестре: Colon Cancer Liver Metastasis, Colon Cancer, Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum. 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

Correlation of Histopathological Findings With Radiation Exposure Levels After Y90 Transarterial Radioembolization (TARE) of Hepatic Metastases: A Feasibility Study

Обзор

The purpose of this study is to study the way radioembolization works by collecting biopsy samples of participants' tumors after the procedure. This research may improve the way that radioembolization is performed, which could help people whose cancer has spread to the liver. The research may also provide information about how tumors respond to radioembolization.

Вмешательства

  • Лучевая терапия Y90 TARE
    Y90 TARE will be performed as standard of care (SOC)/clinically indicated: 1) in a lobar or sub-lobar fashion (depending on tumor involvement and location; also targeting the tumor as selective as possible and sparing as much as possible of non-involved liver parenchyma), for participants with extensive bilobar disease or 2) in a radiation segmentectomy approach, intending to deliver 190 Gy radiation dose to target tumor: for patients with limited liver metastatic disease, not amenable for surge
  • Диагностический тест PET/CT
    Following 90Y TARE, participants will receive a PET/CT or PET/MRI scan to measure the dose administered to the target tumor(s) and uninvolved hepatic parenchyma.
  • Диагностический тест PET/MRI
    Following 90Y TARE, participants will receive a PET/CT or PET/MRI scan to measure the dose administered to the target tumor(s) and uninvolved hepatic parenchyma.

Первичные конечные точки

  • Correlation of tissue necrosis and radiation-induced cell injury levels with delivered dose at 72 hours [Срок оценки: 72 hours after treatment]
  • Correlation of tissue necrosis and radiation-induced cell injury levels with delivered dose at 14-21 days [Срок оценки: Between 14-21 days after treatment]

Критерии участия

Критерии включения

  • age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • histologically confirmed primary adenocarcinoma of the colon or rectum
  • CLM considered unresectable or not amenable to percutaneous ablation
  • existent tissue samples from a standard of care biopsy of the target tumor within 42 days prior to treatment OR clinical indication for biopsy at the time of the treatment under the institutional guidelines for progression of disease.
  • adequate blood cell counts (WBC > 1.5 x 109/L, platelet count > 50 x 109/L)
  • adequate renal function (creatinine < 1.5 mg/dL)
  • total bilirubin level ≤ 1.5 mg/dL

Additional inclusion criteria for patients, undergoing 90Y radiation segmentectomy:

A. patients not amenable to surgery or thermal ablation

Критерии исключения

Study exclusion criteria will be similar to general TARE exclusion criteria, which are as follows:

  • prior hepatic radiotherapy (The lesion / lobe being treated cannot have had prior treatment with radiotherapy - untreated lesions / lobes in the liver may be evaluated under the protocol)
  • severe cirrhosis
  • severe portal hypertension
  • uncorrectable flow to the gastrointestinal tract and/or >30 Gy (or >50 Gy in multiple sessions) radiation absorbed dose to the lungs

All patients with liver-dominant disease will be considered candidates for TARE even in the face of oligometastatic (up to 5 sites) extrahepatic disease, that is stable or controlled by chemotherapy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Memorial Sloan Kettering Cancer Center — New York

Идентификаторы

NCT: NCT04668872 · 20-355

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗