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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. září 2022 aktualizováno: 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).

Přehled studie

Detailní popis

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.

Typ studie

Intervenční

Zápis (Očekávaný)

40

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • West Virginia
      • Morgantown, West Virginia, Spojené státy, 26506
        • WVU Medicine Department of Radiation Oncology

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 90 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Jiný: 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.
Ostatní jména:
  • 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.
Ostatní jména:
  • Superficial Perfusion Oxygen Tension Chip (SPOTchip) measurement
Jiný: 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.
Ostatní jména:
  • 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.
Ostatní jména:
  • Superficial Perfusion Oxygen Tension Chip (SPOTchip) measurement
Jiný: 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.
Ostatní jména:
  • 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.
Ostatní jména:
  • Superficial Perfusion Oxygen Tension Chip (SPOTchip) measurement
Jiný: 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.
Ostatní jména:
  • 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.
Ostatní jména:
  • Superficial Perfusion Oxygen Tension Chip (SPOTchip) measurement

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
To assess change in oxygenation of cutaneous tumors from hyperoxygenation therapy
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
To characterize temporal variations in oxygenation of cutaneous tumors over a course of local radiation therapy and/or systemic chemotherapy or immunotherapy
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
To compare different methods of oxygenation measurement
Časové okno: Up to 1 year
EPR measurements of pO2 using India ink will be compared to cpO2easurements using SPOTChip.
Up to 1 year

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Todd Tenenholz, MD, PhD, West Virginia University Cancer Institute

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

13. června 2018

Primární dokončení (Očekávaný)

1. prosince 2022

Dokončení studie (Očekávaný)

1. prosince 2022

Termíny zápisu do studia

První předloženo

15. července 2019

První předloženo, které splnilo kritéria kontroly kvality

30. září 2019

První zveřejněno (Aktuální)

2. října 2019

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

27. září 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

23. září 2022

Naposledy ověřeno

1. února 2022

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • WVU011118

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ano

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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