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[Duplicate Record to NCT03716193] Measurement of the Partial Pressure of Oxygen in Cutaneous Tumors Using Electron Paramagnetic Resonance (EPR) Oximetry

23 сентября 2022 г. обновлено: West Virginia University

Measurement of the Partial Pressure of Oxygen in Cutaneous Tumors Using Electron Paramagnetic Resonance (EPR) Oximetry

Oxygen has a critical role in the metabolism of tumors and normal tissues and is a key determinant of sensitivity of tissues to ionizing radiation. Knowledge of the relationship between the partial pressure of oxygen (pO2) and radiation sensitivity has been exploited in strategies to enhance oxygenation or to sensitize hypoxic cells to radiation. This study involves taking at least one measurement of the oxygen level in the patient's tumor before, during, and after breathing oxygen through a facemask. The goal of the measurements is to learn more about changes in tumor oxygen levels in response to breathing extra oxygen and standard treatments like chemotherapy and radiation therapy, so that in the future we have a better understanding of how to best use these treatments to improve their ability to fight cancer. By taking measurements of a variety of tumor types undergoing a variety of treatments, we will gain valuable information towards assessing our underlying hypothesis that repeated measurements of tissue oxygen levels can be used to optimize cancer therapy, especially radiation therapy, so that the therapy is applied in a way that maximizes the therapeutic ratio. All patients in this study will receive standard of care therapy for their cancer at the discretion of their treating physician(s).

Обзор исследования

Статус

Приостановленный

Подробное описание

This protocol is designed to demonstrate the clinical feasibility of using in vivo EPR oximetry to obtain clinically useful measurements of tumor oximetry from cancer patients. By taking measurements of a variety of tumor types undergoing a variety of treatments, we will gain valuable information towards assessing our underlying hypothesis that repeated measurements of tissue oxygen levels can be used to optimize cancer therapy, especially radiation therapy, so that the therapy is applied in a way that maximizes the therapeutic ratio. All patients in this study will receive standard of care therapy for their cancer at the discretion of their treating physician(s). All subjects will be assigned to one of the four cohorts below for which they qualify;there is no randomization and no stratification within the cohorts. All measurements will be carried out before, during and after hyperoxygenation therapy * Not all tumor's may be amenable to the SPOTChip or India ink measurements. Similarly, some patients may refuse one or the other. In either of these cases, measurements may still be made with only one of the two probes.

  • For patients in whom measurements are being made while on systemic therapy, the goal of the systemic therapy may be neoadjuvant in curative patients or palliative in metastatic patients.
  • If patients receive chemotherapy at intervals of less than q3 weeks, oximetry measurements should still only be taken at 3-4 week intervals with every other cycle. Patients on systemic therapy for prolonged. The duration of the EPR oximetry measurements will vary t depending on the type of therapy a given patient receives (which determines the cohort they are in). Patients who undergo pre-operative EPR oximetry measurements will not have any follow-up measurements after surgery since the tumor has been excised. Patients who undergo radiation or systemic therapy will have EPR oximetry measurements during treatment, 1 month after completing radiation or systemic therapy and none thereafter. Adverse events specifically related to the India ink injection and EPR oximetry measurements will be followed until resolution, stabilization, or until it has been determined that study participation is not the cause. Adverse events related to cancer-directed therapies (e.g. radiation or systemic therapy) will not be monitored on this study.

Тип исследования

Интервенционный

Регистрация (Ожидаемый)

40

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 90 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  • Man or woman age 18-90
  • Pathology-proven (histology or cytology) malignancy of any histology and site of origin
  • Visible tumor (primary or metastasis) involving the skin of at least 6 mm in diameter.
  • Negative serum or urine pregnancy test within 72 hours prior to registration for women of childbearing potential
  • Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

The presence of any of the following will exclude a subject from study enrollment.

  • Implanted electric, magnetic or mechanically activated devices like a pacemaker, defibrillator, nerve stimulator, cochlear implant or portable infusion pump. Also individuals who have any non-MRI compatible implants.
  • Individuals who have a ferromagnetic foreign body located in their body.
  • Prior adverse reaction to a charcoal product (e.g., a local hypersensitive response from a black tattoo or from ingestion of activated charcoal)
  • Prior adverse reaction to gum Arabic, which is an ingredient in the India ink.
  • Prior allergic reaction to medical adhesives.
  • Psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant or lactating women. There is no known harm to the woman or her fetus from participating; this is precautionary only.
  • Most recent systolic blood pressure < 90 mmHg, or diastolic blood pressure < 60 mmHg, or heart rate < 50 beats per minute, or heart rate > 100 beats per minute.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Нерандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Другой: Cohort 1
Patients who will receive definitive surgery for a primary malignancy of the skin.
The India ink we propose to use in this study consists of 20-50 μL of Carlo Erba India ink injected in subcutaneous or submucosal tissue. This ink (referred to herein as Carlo Erba ink or CE ink or India ink) is based on a paramagnetic black pigment: purified and depyrogenated charcoal manufactured by Carlo Erba that is prepared as a sterile ink using the protocol developed at the lab of Bernard Gallez. The India ink will be injected subdermally into the tumor.
Другие имена:
  • Carlo Erba Ink or CE Ink measurement
The SPOTChip is made in the form of a thin, circular in shape, disc/film having a diameter of 6-mm. After placing the SPOTChip on the tumor, it is covered with an oxygen barrier material secured to the skin by an FDA approved medical transfer adhesive.
Другие имена:
  • Superficial Perfusion Oxygen Tension Chip (SPOTchip) measurement
Другой: Cohort 2
Patients who will receive definitive radiation (+/- concurrent systemic therapy) for a primary malignancy of the skin
The India ink we propose to use in this study consists of 20-50 μL of Carlo Erba India ink injected in subcutaneous or submucosal tissue. This ink (referred to herein as Carlo Erba ink or CE ink or India ink) is based on a paramagnetic black pigment: purified and depyrogenated charcoal manufactured by Carlo Erba that is prepared as a sterile ink using the protocol developed at the lab of Bernard Gallez. The India ink will be injected subdermally into the tumor.
Другие имена:
  • Carlo Erba Ink or CE Ink measurement
The SPOTChip is made in the form of a thin, circular in shape, disc/film having a diameter of 6-mm. After placing the SPOTChip on the tumor, it is covered with an oxygen barrier material secured to the skin by an FDA approved medical transfer adhesive.
Другие имена:
  • Superficial Perfusion Oxygen Tension Chip (SPOTchip) measurement
Другой: Cohort 3
Patients who will receive palliative radiation (+/-concurrent systemic therapy) for any tumor involving the skin.
The India ink we propose to use in this study consists of 20-50 μL of Carlo Erba India ink injected in subcutaneous or submucosal tissue. This ink (referred to herein as Carlo Erba ink or CE ink or India ink) is based on a paramagnetic black pigment: purified and depyrogenated charcoal manufactured by Carlo Erba that is prepared as a sterile ink using the protocol developed at the lab of Bernard Gallez. The India ink will be injected subdermally into the tumor.
Другие имена:
  • Carlo Erba Ink or CE Ink measurement
The SPOTChip is made in the form of a thin, circular in shape, disc/film having a diameter of 6-mm. After placing the SPOTChip on the tumor, it is covered with an oxygen barrier material secured to the skin by an FDA approved medical transfer adhesive.
Другие имена:
  • Superficial Perfusion Oxygen Tension Chip (SPOTchip) measurement
Другой: Cohort 4
Patients who will receive systemic therapy alone (without radiation) for any tumor involving the skin.
The India ink we propose to use in this study consists of 20-50 μL of Carlo Erba India ink injected in subcutaneous or submucosal tissue. This ink (referred to herein as Carlo Erba ink or CE ink or India ink) is based on a paramagnetic black pigment: purified and depyrogenated charcoal manufactured by Carlo Erba that is prepared as a sterile ink using the protocol developed at the lab of Bernard Gallez. The India ink will be injected subdermally into the tumor.
Другие имена:
  • Carlo Erba Ink or CE Ink measurement
The SPOTChip is made in the form of a thin, circular in shape, disc/film having a diameter of 6-mm. After placing the SPOTChip on the tumor, it is covered with an oxygen barrier material secured to the skin by an FDA approved medical transfer adhesive.
Другие имена:
  • Superficial Perfusion Oxygen Tension Chip (SPOTchip) measurement

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
To assess change in oxygenation of cutaneous tumors from hyperoxygenation therapy
Временное ограничение: Up to 1 year
Tumor oxygen kinetics will be measured by EPR oximetry under ambient conditions, during hyperoxygenation therapy (100% O2 administered via a non-rebreather face mask), and immediately after hyperoxygenation therapy.
Up to 1 year

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
To characterize temporal variations in oxygenation of cutaneous tumors over a course of local radiation therapy and/or systemic chemotherapy or immunotherapy
Временное ограничение: Up to 1 year
Patients will undergo weekly tumor oxygen measurements by EPR during a radiation therapy course and every 3-4 week measurements during cycles of systemic therapy. Changes in tumor oxygen will be correlated with standard measures of response to therapy using RECIST criteria.
Up to 1 year

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
To compare different methods of oxygenation measurement
Временное ограничение: Up to 1 year
EPR measurements of pO2 using India ink will be compared to cpO2easurements using SPOTChip.
Up to 1 year

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Следователи

  • Главный следователь: Todd Tenenholz, MD, PhD, West Virginia University Cancer Institute

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

13 июня 2018 г.

Первичное завершение (Ожидаемый)

1 декабря 2022 г.

Завершение исследования (Ожидаемый)

1 декабря 2022 г.

Даты регистрации исследования

Первый отправленный

15 июля 2019 г.

Впервые представлено, что соответствует критериям контроля качества

30 сентября 2019 г.

Первый опубликованный (Действительный)

2 октября 2019 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

27 сентября 2022 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

23 сентября 2022 г.

Последняя проверка

1 февраля 2022 г.

Дополнительная информация

Термины, связанные с этим исследованием

Другие идентификационные номера исследования

  • WVU011118

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Да

продукт, произведенный в США и экспортированный из США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования India Ink measurement

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