Japanese
Albanian
Arabic
Armenian
Azerbaijani
Belarusian
Bengali
Bosnian
Catalan
Czech
Danish
Deutsch
Dutch
English
Estonian
Finnish
Français
Greek
Haitian Creole
Hebrew
Hindi
Hungarian
Icelandic
Indonesian
Irish
Italian
Japanese
Korean
Latvian
Lithuanian
Macedonian
Mongolian
Norwegian
Persian
Polish
Portuguese
Romanian
Russian
Serbian
Slovak
Slovenian
Spanish
Swahili
Swedish
Turkish
Ukrainian
Vietnamese
Български
中文(简体)
中文(繁體)

Surefire Catheter Versus Standard End-hole Microcatheter: A Pilot Study

登録ユーザーのみが記事を翻訳できます
ログインサインアップ
リンクがクリップボードに保存されます
状態
スポンサー
Wright State University
共同編集者
Surefire Medical, Inc.

キーワード

概要

The Surefire Infusion System is a novel catheter initially developed to prevent reflux of embolic material into non-target vascular territories. Further research has demonstrated improved penetration and distribution of embolic material into treated arterial territories. The purpose of this study is to compare Y-90 glass microsphere distribution and penetration into cancerous tissue within the liver between a standard endhole catheter and the Surefire Infusion System.

説明

Yttrium-90 (Y-90) radioembolization is a minimally invasive trans-arterial treatment for primary and secondary hepatic malignancies that relies on tumor hypervascularity for concentration of radioactive microspheres. The Surefire® Infusion System (SIS) (Westminster, CO) was developed to reduce non-target embolization which can result in morbid complications, especially those involving radioembolic or drug eluting microspheres. Prior to its introduction, radioembolization and other trans-arterial therapies have been performed with standard end-hole catheters. In addition to providing protection against non-target embolization, studies have demonstrated improved penetration of embolic material (tantalum microspheres and Tc-99M labeled MAA) with the use of the SIS when compared to conventional end-hole catheters. To date, no study has demonstrated improved distribution and penetration of yttrium-90 glass microspheres with the use of the Surefire catheter versus a standard end-hole catheter. Y-90 distribution can be evaluated with the use of immediate post-delivery PET/CT imaging as it creates its own pair production and can be imaged in the immediate post delivery period. PET/CT will demonstrate distribution and the dose to tumors can be calculated. The investigators propose a pilot study comparing yttrium-90 tumor distribution and concentration in patients with hepatocellular carcinoma (HCC) with the use of the SIS versus a standard end-hole catheter.

日付

最終確認済み: 09/30/2018
最初に提出された: 05/06/2015
提出された推定登録数: 05/14/2015
最初の投稿: 05/17/2015
最終更新が送信されました: 10/08/2018
最終更新日: 10/11/2018
実際の研究開始日: 04/30/2015
一次完了予定日: 07/31/2018
研究完了予定日: 10/31/2018

状態または病気

Hepatocellular Carcinoma

介入/治療

Device: Surefire® Infusion System

Device: Standard End-hole catheter

段階

-

アームグループ

介入/治療
Experimental: Surefire® Infusion System
Patients randomized to the Surefire® Infusion System treatment arm will undergo Y-90 glass microsphere embolization with a Surefire catheter.
Device: Surefire® Infusion System
Utilization of Surefire® Infusion System for Y-90 glass microsphere embolization
Active Comparator: Standard End-hole catheter
Patients randomized to the standard end-hole catheter treatment arm will undergo Y-90 glass microsphere embolization with a standard end-hole catheter.
Device: Standard End-hole catheter
Utilization of Standard End-hole catheter for Y-90 glass microsphere embolization

適格基準

研究の対象となる年齢 18 Years に 18 Years
研究に適格な性別All
健康なボランティアを受け入れるはい
基準

Inclusion Criteria:

- Lobar-only treatments

- Patients with biopsy or radiographically proven hepatocellular carcinoma who are not candidates for transplant, surgical resection or ablative therapy

- Patients 18 years of age and older

- Patients who are able to provide written informed consent

Exclusion Criteria:

- Patients with Barcelona-Clinic Liver Cancer (BCLC) Stage C disease,

- Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3,

- Patients who are unable to tolerate Y-90,

- Patients with arterial anatomy unsuitable to place Surefire catheter,

- Patients with uncorrectable coagulopathy,

- Patients with platelets less than 50 (uncorrectable),

- Bilirubin >3 mg/dl,

- AST or ALT>5x upper limit of normal,

- Patients who are unable to tolerate angiography,

- Patients with < 3 months to live,

- Patients who meet the standard Y-90 exclusion criteria according to package insert

- Female patients who are pregnant

- Patients under the age of 18

- Patients who are unable to provide written informed consent

結果

主な結果の測定

1. Y-90 distribution and concentration as determined by post embolization PET-CT [Up to 12 months]

Y-90 distribution and concentration within targeted hepatocellular carcinoma as determined by post embolization PET-CT.

二次的な結果の測定

1. Secondary outcome (length of duration for arteriogram) [Up to 12 months]

length of duration for arteriogram

2. Secondary outcome (fluoro time duration) [Up to 12 months]

fluoro time duration

3. Secondary outcome (number of vessels requiring coiling) [Up to 12 months]

number of vessels requiring coiling

4. Secondary outcome (tumor response by Response Evaluation Criteria in Solid Tumors) [Up to 12 months]

tumor response by Response Evaluation Criteria in Solid Tumors (m-RECIST criteria)

5. Secondary outcome- toxicities (per standard labs: Total bilirubin; Aspartate aminotransferase (AST); Alanine aminotransferase (ALT); Albumin; International Normalized Ratio (INR); Creatinine; Alpha Fetoprotein (AFP)) [Up to 12 months]

toxicities (per standard labs: Total bilirubin; Aspartate aminotransferase (AST); Alanine aminotransferase (ALT); Albumin; International Normalized Ratio (INR); Creatinine; Alpha Fetoprotein (AFP))

6. Secondary outcome (time to progression of tumor) [Up to 12 months]

time to progression of tumor

7. Secondary outcome (vessel injury) [Up to 12 months]

vessel injury

8. Secondary outcome (MELD) [Up to 12 months]

Model for End-Stage Liver Disease (MELD)

9. Secondary outcome (CPS) [Up to 12 months]

Childs-Pugh Score (CPS)

10. Secondary outcome (non-target embolization) [Up to 12 months]

non-target embolization

11. Secondary outcome (time to death from first treatment) [Up to 12 months]

time to death from first treatment

Facebookページに参加する

科学に裏打ちされた最も完全な薬草データベース

  • 55の言語で動作します
  • 科学に裏打ちされたハーブ療法
  • 画像によるハーブの認識
  • インタラクティブGPSマップ-場所にハーブをタグ付け(近日公開)
  • 検索に関連する科学出版物を読む
  • それらの効果によって薬草を検索する
  • あなたの興味を整理し、ニュース研究、臨床試験、特許について最新情報を入手してください

症状や病気を入力し、役立つ可能性のあるハーブについて読み、ハーブを入力して、それが使用されている病気や症状を確認します。
*すべての情報は公開された科学的研究に基づいています

Google Play badgeApp Store badge