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Идёт набор NCT06593106

Cryodevitalization for the Treatment of Early Stage Lung Cancer, CRYSTAL Trial

Без фазы С лечением Stage I Lung Cancer Stage II Lung 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: Cryosurgery, Robotic Bronchoscopy, Bronchoscopy with Biopsy, Resection.
Кому может быть актуально
Состояния в реестре: Stage I Lung Cancer, Stage II Lung Cancer. 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

The CRYSTAL Study: Cryodevitalization Study for the Treatment of Early-Stage Lung Cancer

Обзор

This clinical trial studies side effects and best treatment time of cryodevitalization in treating patients with early stage (stage I or stage II) lung cancer. Cryodevitalization is a type of cryosurgery that uses a flexible probe (cryoprobe) to kill tumor cells by freezing them. It is delivered at the time of standard diagnostic robotic bronchoscopy. Using cryodevitalization may be safe, tolerable and/or effective in treating patients with early stage lung cancer.

Подробное описание

PRIMARY OBJECTIVE:

I. To identify the maximum tolerated dose (MTD) for cryodevitalization cycle duration.

OUTLINE: This is a dose-escalation study.

Patients undergo 3 freeze-thaw cycles of cryodevitalization over 30 seconds or 3, 5, or 7 minutes each during standard of care robotic bronchoscopy with biopsy on study. Patients then undergo standard of care surgical resection on study. Patients also undergo a chest radiography (x-ray) on study as well as computed tomography (CT) and tissue sample collection throughout the study.

After completion of study treatment, patients are followed up at 3 and 7 days and are then followed as clinically required per standard of care for 24 months.

Вмешательства

  • Процедура Cryosurgery
    Undergo cryodevitalization
  • Процедура Robotic Bronchoscopy
    Undergo standard of care robotic bronchoscopy with biopsy
  • Процедура Bronchoscopy with Biopsy
    Undergo standard of care robotic bronchoscopy with biopsy
  • Процедура Resection
    Undergo standard of care surgical resection
  • Процедура Chest Radiography
    Undergo chest x-ray
  • Процедура Computed Tomography
    Undergo Computed Tomography
  • Процедура Biospecimen Collection
    Undergo tissue sample collection
  • Другое Electronic Health Record Review
    Ancillary studies

Первичные конечные точки

  • Maximum tolerated dose for cryodevitalization cycle duration [Срок оценки: At time of surgery]
  • Feasibility of bronchoscopically delivered cryodevitalization [Срок оценки: At time of surgery]
  • Incidence of adverse events [Срок оценки: Up to 7 days post-cryosurgery]
Вторичные конечные точки (2)
  • Pathologic response [Срок оценки: At time of surgical resection]
  • Incidence of adverse events [Срок оценки: From day 8 post-cryosurgery to surgical resection]

Критерии участия

Критерии включения

  • Patients with a single pulmonary nodule with a size less than or equal to three centimeters (average long and short axis) confirmed as malignant intraprocedurally (rapid on-site evaluation with pathology assessment showing lung cancer or oligometastatic disease) without evidence of mediastinal involvement who require nodule biopsy prior to proceeding with surgical resection
  • Nodules must be located in the outer 2/3 of the periphery of the lung, greater than 10 mm from the pleura and from large blood vessels or mediastinal structures to avoid injury to other visceral organs
  • Patients deemed to have a surgical resection treatment option based on preoperative staging computed tomographic (CT), postoperative predicted forced expiratory volume in 1 second (FEV1) > 40% and evaluation of medical comorbidities after discussion at multidisciplinary tumor board
  • Age > 18 years old

Критерии исключения

  • Target nodule is within the International Association for the Study of Lung Cancer (IASLC) "central zone" (including bronchial tree, major vessels, heart, esophagus, spinal cord and phrenic \& laryngeal nerves), or are < 10 mm from the pleura
  • Patients with an expected survival less than 6 months
  • Patients with endobronchial lesions, concerning for malignancy, visualized during the initial bronchoscopic evaluation of the airways
  • Patients with medically uncorrectable coagulopathy: abnormal platelet count < 100 × 10\^9/L or an international normalized ratio > 1.5
  • Patients with known pulmonary hypertension (PASP \[pulmonary artery systolic pressure\] > 50mmHg)
  • Patients who are currently prescribed anticoagulants, clopidogrel, or other platelet aggregation inhibitors
  • Patients with medical comorbidities deemed high-risk for surgical resection
  • Pregnant women
  • Inability to provide informed consent

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
Лечение

Центры проведения

США · 1 центр
  • Vanderbilt University/Ingram Cancer Center — Nashville

Идентификаторы

NCT: NCT06593106 · VICC-VCTHO24099 · NCI-2024-07299 · P30CA068485

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗