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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 de setembro de 2022 atualizado por: 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).

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Antecipado)

40

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • West Virginia
      • Morgantown, West Virginia, Estados Unidos, 26506
        • WVU Medicine Department of Radiation Oncology

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 90 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Outro: 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.
Outros nomes:
  • 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.
Outros nomes:
  • Superficial Perfusion Oxygen Tension Chip (SPOTchip) measurement
Outro: 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.
Outros nomes:
  • 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.
Outros nomes:
  • Superficial Perfusion Oxygen Tension Chip (SPOTchip) measurement
Outro: 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.
Outros nomes:
  • 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.
Outros nomes:
  • Superficial Perfusion Oxygen Tension Chip (SPOTchip) measurement
Outro: 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.
Outros nomes:
  • 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.
Outros nomes:
  • Superficial Perfusion Oxygen Tension Chip (SPOTchip) measurement

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
To assess change in oxygenation of cutaneous tumors from hyperoxygenation therapy
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
To characterize temporal variations in oxygenation of cutaneous tumors over a course of local radiation therapy and/or systemic chemotherapy or immunotherapy
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
To compare different methods of oxygenation measurement
Prazo: Up to 1 year
EPR measurements of pO2 using India ink will be compared to cpO2easurements using SPOTChip.
Up to 1 year

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Todd Tenenholz, MD, PhD, West Virginia University Cancer Institute

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

13 de junho de 2018

Conclusão Primária (Antecipado)

1 de dezembro de 2022

Conclusão do estudo (Antecipado)

1 de dezembro de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

15 de julho de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ

30 de setembro de 2019

Primeira postagem (Real)

2 de outubro de 2019

Atualizações de registro de estudo

Última Atualização Postada (Real)

27 de setembro de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

23 de setembro de 2022

Última verificação

1 de fevereiro de 2022

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • WVU011118

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Sim

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em Tumores Cutâneos

Ensaios clínicos em India Ink measurement

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