Feasibility of ExAblate MRI Guided High Intensity Focused Ultrasound Tx of Soft Tissue Tumors
2018年4月28日 更新者：Pejman Ghanouni
A Feasibility Study to Evaluate the Safety and Effectiveness of ExAblate Magnetic Resonance Imaging Guided High Intensity Focused Ultrasound Treatment of Soft Tissue Tumors of the Extremities
The goal of this project is to evaluate the safety and preliminary efficacy of ExAblate magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) surgery in the treatment of soft tissue tumors of the extremities.
調査の概要
詳細な説明
Given that the incidence of cancer increases with age, the number of elderly patients diagnosed and treated for soft tissue sarcomas (STS) will increase.
The dilemma is that surgeons and medical oncologists may be hesitant to treat elderly patients in a comparably intensive manner as is used in the treatment of younger patients; factors such as decreased performance status, significant comorbidities, and disease natural history may erode enthusiasm for aggressive STS resection.
To this end, a less invasive way of treating soft tissue tumors would be helpful in younger patients to minimize morbidity and in the elderly to provide less aggressive treatment options.
The InSightec ExAblate 2000 magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system is a non-invasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue (5-10).
The ExAblate combines a focused ultrasound surgery (FUS) delivery system and a conventional diagnostic 1.5 T or 3 T MRI scanner.
It provides a real-time therapy planning algorithm, thermal dosimetry, and closed-loop therapy control.
研究の種類
介入
入学 (実際)
5
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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Stanford、California、アメリカ、94305
- Stanford University School of Medicine
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
10年歳以上 (子、大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
INCLUSION CRITERIA
- ≥ 10 years of age.
- Benign or malignant soft tissue tumors of the extremities, flanks, pelvis, or shoulders requiring surgical intervention.
- Tumor must not have been treated previously with radiation.
- Targeted tumor(s) are accessible to the ExAblate device
- Targeted volume within the tumor is located deeper than 1 cm from the skin
- Targeted tumor is clearly visible by non-contrast magnetic resonance imaging (MRI)
- Karnofsky Performance Status > 60
- Normal platelet count and coagulation profile
- Glomerular filtration rate > 60 mL/min
- Able to safely undergo MRI exam and receive mild sedation for the treatment.
- Able to tolerate being in the MRI scanner for the duration of the study.
- Able and willing to give consent (or consent + assent where applicable), and able to attend all study visits.
EXCLUSION CRITERIA
- Previous radiation treatment to the tumor.
- Currently receiving dialysis.
- Acute medical condition (eg, pneumonia, sepsis) expected to hinder completion of the study
Unstable cardiac status including:
- Unstable angina pectoris on medication
- Patients with documented myocardial infarction within six months of protocol entry
- Congestive heart failure requiring medication (other than diuretic)
- Patients on anti-arrhythmic drugs
- Severe hypertension (diastolic BP > 100 on medication)
- Contraindication for MR imaging such as implanted metallic devices that are not MRI-safe, size limitations, etc
- Severe hematologic, neurologic, or other uncontrolled disease
- Known intolerance or allergy to medications used for sedation (midazolam), analgesia (fentanyl), and local and regional anesthesia (lidocaine, bupivacaine, and ropivacaine)
- Known intolerance or allergy to MR contrast agent (gadolinium chelates) including advanced kidney disease
- Pregnant and nursing
- Karnofsky Performance Score < 60
- Severe cerebrovascular disease [cardiovascular accident (CVA) within 6 months]
- Not able or not willing to tolerate the required prolonged stationary position during treatment (up to 5 hrs of total table time)
- Target volume in tumor is less than 1 cm from neurovascular bundles, major blood vessels, bowel, or bladder.
Targeted tumors:
- NOT visible by non-contrast MRI, OR
- NOT accessible to ExAblate device
- Not a candidate for either regional anesthesia or mild sedation
- Not be participating in another trial testing other investigational agents or devices
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：なし
- 介入モデル：単一グループの割り当て
- 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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実験的：MRgHIFU
The InSightec ExAblate 2000 magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system is a non-invasive device that is fully integrated with an MR imaging system and used for the ablation of soft tissue.
The treatment process begins with the physician acquiring a set of MR images, identifying 1+ target volume(s) of fibroid tissue to be ablated, and drawing the treatment contours.
The therapy planning software computes the type and number of sonications required to treat the defined volume while minimizing total treatment time.
MR images taken during the sonication provide a diagnostic quality image of the target tissue and a quantitative, real-time temperature map overlay to confirm the therapeutic effect of the treatment.
The transducer is then automatically moved to the succeeding treatment point and the process is repeated until the entire volume has been treated.
About 100 individual sonications can be delivered over a 3-hour period to complete a treatment.
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The InSightec ExAblate 2000 magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system is a non-invasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue
他の名前：
325 mg PO for deep venous thrombosis (DVT) prophylaxis initiated 2 hours prior to magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) treatment
他の名前：
40 mg by subcutaneous (SC) administration, for deep venous thrombosis (DVT) prophylaxis initiated 2 hours prior to magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) treatment
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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Overall Safety - Incidence of Any Device-related Adverse Events
時間枠：1 week
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Safety determined by evaluating for the incidence of any device-related adverse events.
Patients will be assessed for pain and limb function, and by clinical examination before and after treatment to collect adverse events related to the treatment.
Safety is reported as the total incidence of device-related adverse events.
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1 week
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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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Adverse Event Severity
時間枠：6 months
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Safety is further assessed by an evaluation of severity for the treatment-related adverse events, reported as the number of adverse events for each of the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grades. CTCAE Severity:
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6 months
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Percent Successful Tumor Ablation
時間枠：Up to 1 week
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In the resected tumor specimen, the volume of the ablated area will be determined by obtaining a digital photograph of each pathology slice.
The region of interest corresponding to the ablated area will be traced, and the ablated area will be calculated for each slice and summed.
Accuracy is assessed as the percent ablated volume relative to pre-treatment tumor volume.
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Up to 1 week
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Pejman Ghanouni, MD, PhD、Stanford University
- 主任研究者：Raffi Avedian, MD、Stanford University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2014年5月1日
一次修了 (実際)
2015年3月24日
研究の完了 (実際)
2015年3月24日
試験登録日
最初に提出
2013年10月15日
QC基準を満たした最初の提出物
2013年10月15日
最初の投稿 (見積もり)
2013年10月17日
学習記録の更新
投稿された最後の更新 (実際)
2018年5月23日
QC基準を満たした最後の更新が送信されました
2018年4月28日
最終確認日
2018年4月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IRB-26667
- VAR0095 (その他の識別子：OnCore)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制機器製品の研究
はい
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
MRgHIFUの臨床試験
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Chin-Jung WangNational Health Research Institutes, Taiwanわからない