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Идёт набор NCT05705219

Development of 3D Multi-Parametric Ultrasound (MPUS) as a Decision Support Tool for Patients

— Наблюдательное Liver Cancer, Adult

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: 3D-MPUS.
Кому может быть актуально
Состояния в реестре: Liver Cancer, Adult. 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

Development of 3D Multi-Parametric Ultrasound (MPUS) as a Decision Support Tool for Patients With Abdominal and Pelvic Tumors Undergoing Therapy

Обзор

This clinical trial studies how well 3-dimensional multi-parametric ultrasound (3D MPUS) imaging works as a decision-support tool for patients with liver tumors undergoing therapy. Continuous and dynamic imaging of patients undergoing therapy is required to monitor early-phase treatment response.

Подробное описание

This clinical trial studies how well 3-dimensional multi-parametric ultrasound (3D MPUS) imaging works as a decision-support tool for patients with liver tumors undergoing therapy. Continuous and dynamic imaging of patients undergoing therapy is required to monitor early-phase treatment response. 3D-MPUS is an inexpensive and safe method, which may provide complementary quantitative functional (perfusion) and tissue characterization information to anatomical radiological assessment or blood biomarkers.

Вмешательства

  • Диагностический тест 3D-MPUS
    Participants will receive approximately \< 20 minutes ultrasound scan to locate the lesion followed by acquisition of 3D-MPUS acquisition.

Первичные конечные точки

  • Diagnostic yield of the 3D-MPUS data acquisition [Срок оценки: Baseline visit]

Критерии участия

Критерии включения

  • Participant has untreated liver metastases from colorectal low-grade adenocarcinoma (biopsy-proven and/or characteristic findings on CT, MRI, or FDG-PET) and has planned to undergo a new course of cancer therapy\*.
  • Participant is age >/=18 years.
  • Participant has at least one target lesion that measures ≥1cm in diameter (minimum size according to RECIST 1.1) with a maximum diameter of 14cm amenable to imaging with ultrasound
  • Participant is willing to comply with protocol requirements.
  • Participant has given written informed consent to participate in this study.
  • Any line of cancer therapy is allowed, including systemic and localized treatments, after any prior treatment. For systemic combination treatments, prior treatment with either drug is allowed at the discretion of the investigators, including rechallenges with the same drug combination, for example upon progression on imaging after a treatment break. For combination treatments where patients start treatment with different drugs at different times, the start date of treatment is determined at the discretion of the investigators and can be the start date of the first drug or of the combination treatment. Repeat participation in the study is allowed, if patients are eligible again per their treatment plan.

Критерии исключения

  • Participant has documented anaphylactic or other severe reaction to any ultrasound contrast media or polyethylene glycol (PEG).
  • Participant has any comorbid condition\*\* that, in the opinion of the treating provider or the Protocol Director, compromises the participant's ability to participate in the study.
  • Participant is pregnant (positive urine or serum beta-hCG) or lactating.
  • Presence of cardiac shunt or presence of pulmonary hypertension (contradiction for ultrasound contrast agent)
  • Renal insufficiency with a creatinine level >1.5mg/dl, per our institutional guidelines (contradiction for CT imaging).
  • Examples: any mental condition that compromises the ability to follow a consent discussion, or to make informed decisions (except if represented by a Legally Authorized Representative \[LAR\]); any condition that makes the participant not a good candidate to have ultrasound exams with contrast agent.

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 · 3 центра
  • Stanford University, School of Medicine — Palo Alto
  • University of California, San Diego — San Diego
  • Thomas Jefferson Hospital — Philadelphia

Идентификаторы

NCT: NCT05705219 · IRB-68310 · R01CA195443 · NCI-2024-03676

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗