[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
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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West Virginia
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Morgantown、West Virginia、アメリカ、26506
- WVU Medicine Department of Radiation Oncology
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:非ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の:Cohort 1
Patients who will receive definitive surgery for a primary malignancy of the skin.
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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.
他の名前:
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.
他の名前:
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他の:Cohort 2
Patients who will receive definitive radiation (+/- concurrent systemic therapy) for a primary malignancy of the skin
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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.
他の名前:
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.
他の名前:
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他の:Cohort 3
Patients who will receive palliative radiation (+/-concurrent systemic therapy) for any tumor involving the skin.
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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.
他の名前:
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.
他の名前:
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他の:Cohort 4
Patients who will receive systemic therapy alone (without radiation) for any tumor involving the skin.
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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.
他の名前:
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.
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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To assess change in oxygenation of cutaneous tumors from hyperoxygenation therapy
時間枠:Up to 1 year
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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.
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Up to 1 year
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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To characterize temporal variations in oxygenation of cutaneous tumors over a course of local radiation therapy and/or systemic chemotherapy or immunotherapy
時間枠:Up to 1 year
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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
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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To compare different methods of oxygenation measurement
時間枠:Up to 1 year
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EPR measurements of pO2 using India ink will be compared to cpO2easurements using SPOTChip.
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Up to 1 year
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Todd Tenenholz, MD, PhD、West Virginia University Cancer Institute
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- WVU011118
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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India Ink measurementの臨床試験
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Guangzhou Ruixin Biotechnological Co., LTDFifth Affiliated Hospital of Guangzhou Medical Universityまだ募集していません
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Guangzhou Ruixin Biotechnological Co., LTDWeifang People's Hospital招待による登録
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City of Hope Medical CenterNational Cancer Institute (NCI)積極的、募集していない再発小リンパ球性リンパ腫 | 難治性慢性リンパ性白血病 | 再発性慢性リンパ性白血病 | 難治性小リンパ球性リンパ腫アメリカ
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Narendranath Epperla引きこもった再発辺縁帯リンパ腫 | 再発濾胞性リンパ腫 | 難治性濾胞性リンパ腫 | 難治性辺縁帯リンパ腫 | 難治性節性辺縁帯リンパ腫 | 再発節性辺縁帯リンパ腫 | 再発脾辺縁帯リンパ腫 | 難治性脾辺縁帯リンパ腫 | 難治性緩徐進行性非ホジキンリンパ腫
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PATHUniversity College, London; FHI 360; Medical Research Council Unit, The Gambia; Serum Institute...完了
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Emory UniversityNational Cancer Institute (NCI); Novartis; Secura Bio, Inc.完了再発びまん性大細胞型B細胞リンパ腫 | 難治性びまん性大細胞型B細胞リンパ腫アメリカ
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David Bond, MD完了慢性リンパ性白血病 | 再発びまん性大細胞型B細胞リンパ腫 | 難治性びまん性大細胞型B細胞リンパ腫 | 小リンパ球性リンパ腫 | リヒター症候群 | 形質転換濾胞性リンパ腫からびまん性大細胞型B細胞リンパ腫へ | 慢性リンパ性白血病からびまん性大細胞型B細胞リンパ腫への転換 | 小リンパ球性リンパ腫からびまん性大細胞型B細胞リンパ腫への形質転換アメリカ