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Идёт набор NCT06586892

Quantitative Imaging Biomarker Prospective Validation of Dynamic Contrast-enhanced MRI as a Metric of Orodental Injury After Radiotherapy (QI-ProVE-MRI)

— Наблюдательное Orodental Injury

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: Radiotherapy followed by chemotherapy.
Кому может быть актуально
Состояния в реестре: Orodental Injury. 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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Обзор

This research will focus on the prospective qualification and validation of dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) candidate biomarkers (i.e., Ktrans and Ve) to assess the natural history of osteoradionecrosis (ORN) and treatment for this devastating complication related to irradiation of head and neck cancers. The investigations will also include assessment of DCE-MRI candidate biomarkers for pre-qualification as quantitative imaging biomarkers of soft-tissue structures.

Подробное описание

This prospective observational study will acquire DCE-MRI data from 200 evaluable patients, specifically with an elevated dosimetric risk to assure an event rate of 20% by 36 months post-radiation, sufficient to demonstrate biomarker performance in the clinical cohort most reflective of relative ORN risk. The final study cohort will consist of individuals undergoing definitive radiotherapy for primary head and neck malignancy. The study subjects will include patients with primarily elevated risk of ORN based on clinical (e.g., pre-RT dental procedures) and dosimetric risk factors we established in prior work (e.g., D30\>50Gy, V44 ≥ 42%, or V58 ≥ 25%). All subjects will receive standard IMRT or IMPT as part of their standard clinical care, and treatment plans delivered will be in no way modified based on experimental imaging. Multi-parametric DCE-MRI imaging will be serially performed as per this study's manual of procedures. Clinical data regarding for evaluation of possible dental, mandibular, as well as other normal tissue organs-at-risk side effects will be collected prospectively from medical and dental records for correlation with the DCE-MRI imaging biomarkers. Functional outcomes and patient-reported outcomes questionnaires will be completed to detail outcomes of the continuum of treatment and survivorship.

Вмешательства

  • Поведенческое Radiotherapy followed by chemotherapy
    Researchers would like to test the accuracy of the MRI data being used for this study. If you agree, you will have 2 additional MRI scans within 2 weeks before Visit 1. The first 90 participants who agree will be selected to have the following scans: * 35 participants will be scanned 2 times on one MRI device (Device #1). * 35 participants will be scanned 2 times on another MRI device (Device #2). * 20 participants will be scanned 1 time on both MRI devices (Device #1 and #2). If you agree and

Первичные конечные точки

  • Overall Survival [Срок оценки: Up to 60 months]

Критерии участия

Критерии включения

Provide signed and dated informed consent form.

  • Aged 18 years or older.
  • Have histologic evidence of malignant neoplasm that may have been obtained from the primary tumor or metastatic lymph node.
  • Have a clinical decision made to receive external beam radiation therapy (EBRT) with curative intent, with or without concomitant chemotherapy.
  • Have a good performance status (ECOG score 0-2) evaluated during screening (4 weeks prior to baseline imaging).
  • Be willing to comply with all study procedures.
  • Be willing to participate for the duration of the study.
  • Have elevated dosimetric risk mainly characterized by any of the following criteria:
  • D30>50Gy: 30% of the whole-mandible volume received a dose greater than 50 Gy
  • V44 ≥ 42%: at least 42% of the volume received a dose of 44 Gy or more or
  • V58 ≥ 25%: at least 25% of the volume received a dose of 58 Gy or more.

Критерии исключения

Unable to tolerate DW-MRI or DCE-MRI;

  • Having an estimated GFR < 30 ml/min/1.73 m2;
  • Contraindication to MRI (e.g., non-MRI compatible metallic implants)
  • Pregnant females
  • Unable or unwilling to give written, informed consent to undergo MRI imaging.
  • Claustrophobia
  • Unable to obtain imaging studies of adequate quality to assess imaging-based biomarkers.

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
  • The University of Texas M. D. Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT06586892 · 2024-0406 · NCI-2024-06902

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗