Меню
Идёт набор NCT07225114

Translation of Acoustic Angiography: Contrast Enhanced Super Resolution (CESR) Imaging

Фаза II С лечением Breast Cancer Kidney Neoplasms Liver Neoplasms

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: contrast agent perflutren lipid, Ultrasound Imaging.
Кому может быть актуально
Состояния в реестре: Breast Cancer, Kidney Neoplasms, Liver Neoplasms. 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Academic-Industrial Partnership for Translation of Acoustic Angiography: Contrast Enhanced Super Resolution (CESR) Imaging

Обзор

This is a 4-arm, single-center study involving 40 participants. Ten healthy volunteers will be enrolled for system imaging optimization, and thirty (30) patients with previously identified lesions in the breast, liver, or kidney-based on prior ultrasound or cross-sectional imaging-will be imaged. Recruitment will be conducted such that ten patients are included from each anatomic region. The fourth arm will consist of 10 healthy volunteers who will be imaged to allow optimization of imaging parameters. Optimization is is required again due to the use of a different ultrasound system employing a new imaging technique. Parameters such as frame rate, power, depth of imaging, and linear translation rate will be adjusted during this process. The primary objectives of the study are to assess the sensitivity and specificity of Contrast Enhanced Super-Resolution (CESR) imaging in evaluating known lesions in the breast, liver, and kidney. These results will be compared with pathological findings. The secondary objectives are to compare the sensitivity and specificity of CESR imaging with those of traditional B-mode ultrasound in differentiating malignant from benign lesions in these same organs.

Вмешательства

  • Препарат contrast agent perflutren lipid
    At the time of imaging, the contrast agent perflutren lipid will be administered, intravenous (IV). All patients will be visually monitored for signs or symptoms of a contrast administration reaction once the drug is administered for a 15-minute period.
  • Устройство Ultrasound Imaging
    Contrast Enhanced Super Resolution (CESR) imaging involves a research ultrasound scanner as well as conventional b-mode ultrasound to guide the location of the imaging. The conventional ultrasound will be conducted just prior to CESR imaging for localization.

Первичные конечные точки

  • Sensitivity of Contrast Enhanced Super-Resolution (CESR) breast imaging [Срок оценки: Biopsy date (Up to 2 months)]
  • Specificity of Contrast Enhanced Super-Resolution (CESR) breast imaging [Срок оценки: Biopsy date (Up to 2 months)]
  • Sensitivity of Contrast Enhanced Super-Resolution (CESR) kidney imaging [Срок оценки: Biopsy date (Up to 2 months)]
  • Specificity of Contrast Enhanced Super-Resolution (CESR) kidney imaging [Срок оценки: Biopsy date (Up to 2 months)]
  • Sensitivity of Contrast Enhanced Super-Resolution (CESR) liver imaging [Срок оценки: Biopsy date (Up to 2 months)]
  • Specificity of Contrast Enhanced Super-Resolution (CESR) liver imaging [Срок оценки: Biopsy date (Up to 2 months)]
Вторичные конечные точки (3)
  • Comparison of Contrast Enhanced Super-Resolution (CESR) imaging with traditional b-mode ultrasound- breast [Срок оценки: Biopsy date (Up to 2 months)]
  • Comparison of Contrast Enhanced Super-Resolution (CESR) imaging with traditional b-mode ultrasound- kidney [Срок оценки: Biopsy date (Up to 2 months)]
  • Comparison of Contrast Enhanced Super-Resolution (CESR) imaging with traditional b-mode ultrasound- liver [Срок оценки: Biopsy date (Up to 2 months)]

Критерии участия

Критерии включения

  • Adults ≥18 years old
  • Patient had a diagnostic ultrasound study performed at University of North Carolina
  • Scheduled for a biopsy
  • Lesion visualized on ultrasound
  • Able to provide informed consent
  • Negative urine pregnancy test in women of child-bearing potential

Критерии исключения

  • Institutionalized subject (prisoner or nursing home patient)
  • Critically ill or medically unstable and whose critical course during the observation period would be unpredictable (e.g., chronic obstructive pulmonary disease (COPD)
  • Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®)
  • Active cardiac disease including any of the following
  • Severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association)
  • Unstable angina.
  • Severe arrhythmia (i.e., ventricular tachycardia, flutter fibrillation; ventricular premature complexes occurring close to the preceding T-wave, multifocal complexes).
  • Myocardial infarction within 14 days prior to the date of proposed Definity® administration.
  • Pulmonary hypertension
  • Cardiac shunts

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

США · 1 центр
  • The University of North Carolina — Chapel Hill

Идентификаторы

NCT: NCT07225114 · LCCC2451 · R01CA220681

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗