- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04112342
[Duplicate Record to NCT03716193] Measurement of the Partial Pressure of Oxygen in Cutaneous Tumors Using Electron Paramagnetic Resonance (EPR) Oximetry
Measurement of the Partial Pressure of Oxygen in Cutaneous Tumors Using Electron Paramagnetic Resonance (EPR) Oximetry
Přehled studie
Postavení
Podmínky
Intervence / Léčba
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
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
West Virginia
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Morgantown, West Virginia, Spojené státy, 26506
- WVU Medicine Department of Radiation Oncology
-
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
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
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:
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:
|
|
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:
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:
|
|
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:
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:
|
|
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:
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:
|
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.
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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
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Todd Tenenholz, MD, PhD, West Virginia University Cancer Institute
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- WVU011118
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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