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Идёт набор NCT03582124

Panitumumab-IRDye800 in Detecting Cancer in Participants With Lung Cancer During Surgery

Фаза I / Фаза II С лечением Lung Carcinoma Metastatic Malignant Neoplasm in the Lung Stage IV Lung Cancer AJCC v8 Stage IVA Lung Cancer AJCC v8

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: Near-Infrared Fluorescence Imaging, Panitumumab-IRDye800, Pharmacokinetic Study, Therapeutic Conventional Surgery.
Кому может быть актуально
Состояния в реестре: Lung Carcinoma, Metastatic Malignant Neoplasm in the Lung, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8. 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

A Phase I/II Study Evaluating the Safety and Pharmacokinetics of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Lung Cancer During Surgical Procedures

Обзор

This phase I/II trial studies the best dose and timing of panitumumab-IRDye800 in detecting cancer in participants with lung cancer during the surgery. Panitumumab-IRDye800 is a combination of the antibody drug panitumumab and IRDye800CW, an investigational dye that can be seen using a special camera. Panitumumab-IRDye800 may attach to tumor cells and make them more visible during surgery in patients with lung cancer.

Подробное описание

PRIMARY OBJECTIVES:

I. To determine the optimal dose and timing of panitumumab IRDye800 infusion for identifying lung cancer compared to surrounding normal tissue in the ex vivo setting as measured by tumor to background ratio.

SECONDARY OBJECTIVES:

I. Determine the safety and tolerability of the panitumumab IRDye800 as an imaging agent in subjects undergoing resection of lung cancer.

II. Determine whether the primary lung tumor or positive lymph nodes can be detected by near-infrared (NIR) fluorescence imaging with panitumumab IRDye800 but not by white light imaging.

OUTLINE: This is a phase I, dose-escalation study of panitumumab-IRDye800 followed by a phase II study.

Participants receive panitumumab- IRDye800 intravenously (IV) over 60 minutes on day 0, and then undergo NIR and surgery within 1-5 days.

After completion of study treatment, participants are followed up for up to 30 days.

Вмешательства

  • Процедура Near-Infrared Fluorescence Imaging
    Undergo imaging
  • Препарат Panitumumab-IRDye800
    Given IV
  • Другое Pharmacokinetic Study
    Correlative studies
  • Процедура Therapeutic Conventional Surgery
    Undergo surgery

Первичные конечные точки

  • Tumor to background ratio (TBR), measured in ex vivo tissues [Срок оценки: Up to 1 year]
Вторичные конечные точки (4)
  • Number of Grade 2 or higher AEs determined to be clinically significant and definitely, probably or possibly related to study drug [Срок оценки: Up to 30 days]
  • Metastatic lesion detection by Panitumumab-IRDye800 versus standard assessments [Срок оценки: Up to 1 year]
  • Tumor-positive lymph node detection by Panitumumab-IRDye800 versus standard assessments [Срок оценки: Up to 1 year]
  • Residual disease detection by Panitumumab-IRDye800 versus standard assessments [Срок оценки: Up to 1 year]

Критерии участия

Критерии включения

  • Patients with lung nodule or mass concerning for malignancy, either primary lung cancer or lung metastases, whether or not it is biopsy-proven
  • Patients scheduled to undergo planned standard of care surgical resection for a lung nodule or mass with diagnostic and/or curative intent for lung cancer
  • Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 0-2
  • Hemoglobin ≥ 9 gm/dL
  • White blood cell count > 3000/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Serum creatinine ≤ 1.5 times upper reference range

Критерии исключения

  • Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800
  • 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 monoclonal antibody therapies
  • Pregnant or breastfeeding
  • Magnesium or potassium lower than the normal institutional values
  • Subjects receiving class IA (quinidine, procanamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
  • Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
  • Prisoners, institutionalized individuals, and patients unable to consent for themselves

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
Диагностика

Центры проведения

США · 1 центр
  • Stanford University, School of Medicine — Palo Alto

Идентификаторы

NCT: NCT03582124 · IRB-41302 · NCI-2018-00494 · LUN0099

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗