An Investigational Scan (hpMRI) for Monitoring Treatment Response in Patients With Thyroid Cancer and Other Malignancies of the Head and Neck Undergoing Radiation Therapy and/or Systemic Therapy

Официальное название

Pilot Study of Metabolic Guidance for Therapy in Patients With Thyroid Cancer and Other Malignancies of the Head and Neck

Обзор

This trial investigates whether hyperpolarized magnetic resonance imaging (hpMRI) can predict treatment response in patients with thyroid cancer and other malignancies of the head and neck undergoing radiation therapy and/or receiving systemic therapy before surgery. An hpMRI is like a standard MRI but involves the use of an imaging contrast agent called hyperpolarized 13-C-pyruvate. Diagnostic procedures, such as hpMRI, may predict a patient's response to treatment and may help plan the best treatment.

Подробное описание

PRIMARY OBJECTIVE:

I. To obtain pilot metabolic imaging data from hyperpolarized magnetic resonance imaging (hpMRI) methods in patients with thyroid tumors or other malignancies of the head and neck receiving radiation therapy (XRT) and/or systemic therapy (e.g., target therapy, checkpoint inhibitors).

SECONDARY OBJECTIVE:

I. To assess early metabolic changes in response to nonsurgical therapy, including standard-of-care fractionated XRT and/or systemic therapy.

OUTLINE: Participants are assigned to 1 of 2 arms.

ARM I: Healthy volunteers undergo MRI over 30 minutes.

ARM II: Patients with thyroid cancer and other malignancies of the head and neck undergo hpMRI over 30 minutes at baseline, and at 1 week after the initiation of treatment. During the scan, patients also receive hyperpolarized 13-C-pyruvate intravenously (IV) over 30 seconds and may receive a standard MRI contrast agent at the discretion of the treating physician.

After completion of study intervention, thyroid cancer and other malignancies of the head and neck patients are followed up at 1 day.

Вмешательства

• Препарат Hyperpolarized Carbon C 13 Pyruvate
  Given IV
• Процедура Magnetic Resonance Imaging
  Undergo MRI
• Процедура Magnetic Resonance Imaging
  Undergo hpMRI

Первичные конечные точки

• Metabolic imaging data from hyperpolarized magnetic resonance imaging (hpMRI) methods [Срок оценки: 1 year]

Вторичные конечные точки (1)

• Early metabolic changes [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Be willing and able to provide informed consent
• Be informed of the investigational nature of this study
• Be diagnosed with thyroid cancer and other malignancies of the head and neck with intent for treatment

Критерии исключения

• Have a history of severe claustrophobia
• Have electrically, magnetically or mechanically activated implants that would preclude magnetic resonance imaging (MRI)
• Have a history of cardiac arrhythmia
• Have an allergy to Gadavist intravenous contrast
• Estimated glomerular filtration rate (eGFR) < 30
• If female, be pregnant or breast feeding at time of consent

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

• M D Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT04589624 · 2020-0482 · NCI-2020-05843 · 2020-0482

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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