Surefire Catheter Versus Standard End-hole Microcatheter: A Pilot Study
キーワード
概要
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
介入/治療
Device: Surefire® Infusion System
Device: Standard End-hole catheter
段階
アームグループ
| 腕 | 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]
二次的な結果の測定
1. Secondary outcome (length of duration for arteriogram) [Up to 12 months]
2. Secondary outcome (fluoro time duration) [Up to 12 months]
3. Secondary outcome (number of vessels requiring coiling) [Up to 12 months]
4. Secondary outcome (tumor response by Response Evaluation Criteria in Solid Tumors) [Up to 12 months]
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]
6. Secondary outcome (time to progression of tumor) [Up to 12 months]
7. Secondary outcome (vessel injury) [Up to 12 months]
8. Secondary outcome (MELD) [Up to 12 months]
9. Secondary outcome (CPS) [Up to 12 months]
10. Secondary outcome (non-target embolization) [Up to 12 months]
11. Secondary outcome (time to death from first treatment) [Up to 12 months]
