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Идёт набор NCT05747625

(89Zr Panitumumab) With PET/CT for Diagnosing Metastases in Patients With Head and Neck Squamous Cell Carcinoma

Фаза I С лечением Head and Neck Squamous Cell Carcinoma Metastatic Head and Neck Squamous Cell Carcinoma Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck

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: Panitumumab, Zirconium Zr 89 Panitumumab, Positron Emission Tomography, Computed Tomography.
Кому может быть актуально
Состояния в реестре: Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma, Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck. Базовые параметры: от 19 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

Study Evaluating 89Zr Panitumumab for Assessment of Indeterminate Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma

Обзор

The goal of this phase I clinical trial is to evaluate the usefulness of an imaging test (zirconium Zr89 panitumumab \[89Zr panitumumab\]) with positron emission tomography (PET)/computed tomography (CT) for diagnosing the spread of disease from where it first started (primary site) to other places in the body (metastasis) in patients with head and neck squamous cell carcinoma. Traditional PET/CT has a low positive predictive value for diagnosing metastatic disease in head and neck cancer. 89Zr panitumumab is an investigational imaging agent that contains radiolabeled anti-EGFR antibody which is overexpressed in head and neck cancer. The main question this study aims to answer is the sensitivity and specificity of 89Zr panitumumab for the detection of indeterminate metastatic lesions in head and neck cancer. Participants will receive 89Zr panitumumab infusion and undergo 89Zr panitumumab PET/CT 1 to 5 days after infusion. Participants will otherwise receive standard of care evaluation and treatment for their indeterminate lesions. Researchers will compare the 89Zr panitumumab to standard of care imaging modalities (magnetic resonance imaging (MRI), CT, and/or PET/CT).

Подробное описание

PRIMARY OBJECTIVE:

\- Determine the sensitivity and specificity of zirconium Zr 89 panitumumab (89Zrpanitumumab) for the detection of indeterminate metastatic lesions in head and neck squamous cell carcinoma.

SECONDARY OBJECTIVE:

\- Compare sensitivity and specificity of standard of care imaging modalities (magnetic resonance imaging \[MRI\], CT and/or fludeoxyglucose F-18 \[18F\]-PET/CT) to 89Zr-panitumumab-PET/CT for detection of indeterminate metastatic lesions in head and neck squamous cell carcinoma.

EXPLORATORY OBJECTIVE:

\- Determine rate of intervention (e.g., biopsy or other invasive procedures) versus (vs) non-intervention (e.g., serial imaging, observation) by treatment team in subjects with indeterminate metastatic lesions on standard of care imaging.

OUTLINE:

Patients receive panitumumab intravenously (IV), 89Zr panitumumab IV, and undergo PET/CT on study.

Вмешательства

  • Биопрепарат Panitumumab
    Given IV
  • Препарат Zirconium Zr 89 Panitumumab
    Given IV
  • Процедура Positron Emission Tomography
    Undergo PET/CT
  • Процедура Computed Tomography
    Undergo PET/CT
  • Другое Electronic Health Record Review
    Ancillary studies

Первичные конечные точки

  • Sensitivity of zirconium Zr 89 panitumumab (89Zr-panitumumab [Срок оценки: Up to 7 years]
  • Specificity of 89Zr-panitumumab [Срок оценки: Up to 7 years]
Вторичные конечные точки (2)
  • Sensitivity of 89Zr-panitumumab [Срок оценки: Up to 7 years]
  • Specificity of 89Zr-panitumumab [Срок оценки: Up to 7 years]

Критерии участия

Критерии включения

  • Age >= 19 years
  • Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck
  • Subjects diagnosed with any T stage, any subsite within the head and neck. Subjects with recurrent disease or a new primary will be allowed
  • Must have evidence of indeterminate metastatic squamous cell carcinoma (SCC) based on 18F-fluorodeoxyglucose (FDG)-PET/CT or Primary SCC with suspicious Lymph Nodes on CT prior to surgical removal
  • Hemoglobin >= 9gm/dL
  • White blood cell count > 3000/mm\^3
  • Platelet count >= 100,000/mm\^3
  • Serum creatinine =< 1.5 times upper reference range

Критерии исключения

  • Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
  • History of infusion reactions to other monoclonal antibody therapies
  • Pregnant (based on screening serum pregnancy test and day 0 urine pregnancy test administered before unlabeled panitumumab), or breastfeeding
  • Magnesium or potassium lower than the normal institutional values
  • Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
  • Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
  • Severe renal disease or anuria
  • Known hypersensitivity to deferoxamine or any of its components

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/Ingram Cancer Center — Nashville

Идентификаторы

NCT: NCT05747625 · VICCHN2279 · NCI-2023-01365

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗