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Идёт набор NCT06915454

High-Resolution PET-CT Imaging for Surgical Margin Visualization

Без фазы С лечением Cancer Solid Malignant Tumors SCC - Squamous Cell Carcinoma HNSCC

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: Intra-op PET/CT Specimen Scanner.
Кому может быть актуально
Состояния в реестре: Cancer, Solid Malignant Tumors, SCC - Squamous Cell Carcinoma, HNSCC. 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

High-resolution Specimen PET-CT Imaging for the Intraoperative Visualization of Resection Margins: an Exploratory Study

Обзор

Imaging will be exploratory and be used intraoperatively. There have been no discovered risks associated with the device to be used in this study, and none are anticipated given the diagnostic and non-invasive, 'ex vivo' nature of device use. Of note, the surgical resection will proceed as per standard of care and will not be affected by the research protocol. Potential Benefit: Imaging intra-operatively will ensure surgeons to identify at risk resection margins. Time Commitment: There are no additional visits that will be asked of you to partake in this study. Drug is FDA approved and Exposure to Radiation is minimal.

Подробное описание

This pilot study explores the use of high-resolution PET imaging to identify surgical margins in solid tumors after removal. It evaluates the feasibility and potential of using PET-CT to assess tumor specimens and ensures radiation safety with a low-dose 18-FDG injection (20% of the standard dose). Previous studies have shown good tumor visualization in breast, pancreatic, prostate, and head and neck tumors, supporting the method's proof-of-concept. This research aims to gather insights into its clinical usefulness across different cases

Вмешательства

  • Устройство Intra-op PET/CT Specimen Scanner
    Once the tumor or cancer is resected, it will then be imaged with the XEOS Aura 10 PET/CT Imaging Device. Imaging will be obtained utilizing a XEOS AURA 10 scanner in real time while in the operating room with the surgery team still present.

Первичные конечные точки

  • The study will determine the feasibility of intraoperative high-resolution specimen PET-CT imaging in solid tumors. [Срок оценки: Day of Surgery.]
Вторичные конечные точки (3)
  • Correlate the margin status based on high-resolution specimen PET-CT images with the actual margin status based on gold standard microscopic histopathological analysis; [Срок оценки: Day of Surgery to Pathology]
  • Correlate lymph node status based on high-resolution specimen PET-CT images with the actual lymph node status based on gold standard microscopic histopathological analysis [Срок оценки: Day of Surgery to Pathology]
  • Compare the visualization of the target lesion between intraoperative high-resolution specimen PET-CT imaging and pre-operative whole-body PET-CT imaging (when performed per standard of care oncologic work-up). [Срок оценки: Day of Surgery to 10 days.]

Критерии участия

Критерии включения

  • Biopsy confirmed diagnosis of any solid malignancy
  • Diagnosis of any T stage, any subsite that are scheduled to undergo definitive en bloc surgical resection. Patients with recurrent disease or a new primary will be allowed.
  • Planned standard of care oncologic surgery with curative intent
  • Male or female patients age ≥ 18 years
  • Have life expectancy of more than 12 weeks
  • Karnofsky performance status of at least 70% or ECOG/Zubrod level 1
  • Have acceptable glucose status (<200 mg/dL) at Day of Surgery prior to 18F-FDG injection

Критерии исключения

  • General or local contraindications for resective surgery
  • Women who are pregnant or breast-feeding
  • Blood glucose level over 200 mg/dL prior to 18F-FDG infusion
  • Any participation in other clinical trials or research study that involved a radiation exposure of more than 1 mSv in the past year. If the participant had radiation exposure greater than 1 mSv as SOC, they would not be excluded unless the Principal Investigator determines that patient could be at risk.

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
Поддерживающая терапия

Центры проведения

США · 1 центр
  • Vanderbilt University Medical Center — Nashville

Публикации

  • Radevic A, Austerlitz J, McAdoo A, Golliday K, Takahashi T, Mehrad M, Rosenberg AJ, Murphy BA, Rosenthal E, Topf MC. Visualization of Scattered Tumor Regression Following Neoadjuvant Chemoimmunotherapy With a Novel Intraoperative PET/CT Scanner. Head Neck. 2026 May 25. doi: 10.1002/hed.70333. Online ahead of print. PMID 42185750

Идентификаторы

NCT: NCT06915454 · VICCHNP24616

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗