A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning. (ADVANCE-MCD)
A Post Approval Single-arm Study Evaluating Transarterial Radioembolization Treatment for Hepatocellular Carcinoma Using Multicompartment Dosimetry Planning
The purpose of this study is to assess the safety and effectiveness of treating a tumor using a different planning method called MCD for the FDA-Approved device, TheraSphere.
TheraSphere Microspheres are microscopic radioactive glass spheres that deliver radiation therapy in the liver tissue where they are placed. This study investigates a procedure called multicompartment dosimetry (MCD). When using a multicompartment dosimetry approach, the doctor will look at images of the liver to see where there is tumor to determine where to treat. That area will be divided into "compartments" where the dose to tumor and the healthy liver are calculated separately. The goal of MCD is to give the tumor a higher radiation dose while protecting more of the healthy part of the liver.
Traditional planning for the TheraSphere Microspheres procedure uses single compartment dosimetry (SCD) which treats the tumor and the healthy liver as one area so the dose is more evenly distributed and the dose to the tumor may be lower than with the MCD approach. The single compartment approach is standard and is well established however this research study is to see if giving TheraSphere Microspheres with an MCD planning method is safe and effective by evaluating the effect of radiation on the liver as well as how the tumor responds to higher doses
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Natalie Lydon, MHA
- 電話番号：+1 (612) 240-6364
- メール：natalie.lydon@bsci.com
研究連絡先のバックアップ
- 名前：Krista Asmus, MPH
- 電話番号：+1 (952) 356-9553
- メール：krista.asmus@bsci.com
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- TheraSphere Microspheres treatment determined as the optimal therapy
- Have unresectable solitary HCC
- Treatment Naïve
- ECOG 0 or 1
- Adequate liver function
- Adequate renal and marrow function
- Negative pregnancy test and/or adequate contraception for the patient and his/her sexual partner
Exclusion Criteria:
- Macrovascular invasion
- Extrahepatic metastases
- Previous or current ascites/encephalopathy
- Previous liver radiation, TACE, or systemic therapy for the disease
- History of organ allograft including bone marrow
- Any significant comorbities or contraindications to TheraSphere
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Unresectable Hepatocellular Carcinoma
Patients with unresectable hepatocellular carcinoma (HCC) with tumor sizes 1-8cm.
Patients will be candidates for TheraSphere Microspheres and planning to undergo the procedure as part of their treatment plan.
|
Placement of TheraSphere Microspheres into the area of the primary tumor using multicompartment dosimetry instead of single compartment dosimetry
|
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 |
|---|---|---|
|
Primary Safety Endpoint
時間枠：4 months
|
The rate of Radioembolization Induced Liver Disease (REILD) Grade ≥3 occurring up to 4 months after any TheraSphere Microspheres treatment administration before progression.
|
4 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Secondary Safety Endpoint
時間枠：13 months
|
Number of device- and/or procedure-related adverse events (AEs) and serious adverse events (SAEs), measured by count (number of events).
|
13 months
|
|
Secondary Safety Endpoint
時間枠：13 months
|
Change from baseline in Albumin Bilirubin (ALBI) score, measured using the ALBI index.
|
13 months
|
|
Secondary Safety Endpoint
時間枠：13 months
|
Most severe grade of hepatotoxicity following radioembolization, assessed using CTCAE grading criteria.
|
13 months
|
|
Secondary Effectiveness Endpoint
時間枠：13 months
|
Objective Response Rate (ORR) as assessed by localized mRECIST criteria.
|
13 months
|
|
Secondary Effectiveness Endpoint
時間枠：13 months
|
Duration of Response (DoR) evaluated by localized mRECIST and mRECIST criteria.
|
13 months
|
|
Secondary Effectiveness Endpoint
時間枠：13 months
|
Number of patients who become eligible for liver transplantation or liver resection following treatment, measured by total count (number of patients).
|
13 months
|
|
Secondary Effectiveness Endpoint
時間枠：13 months
|
Histopathologic response assessment in patients who undergo surgical resection, collected through descriptive and categorial data points.
|
13 months
|
|
Secondary Effectiveness Endpoint
時間枠：13 months
|
Overall Survival (OS), defined as the time from treatment initiation to death from any cause, measured in months.
|
13 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
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。
肝細胞がん（HCC）の臨床試験
-
Guangzhou Virotech Pharmaceutical Co., Ltd.募集
-
University of PisaAzienda Ospedaliera Città della Salute e della Scienza di Torino; Fondazione Policlinico Universitario... と他の協力者募集
-
Huazhong University of Science and Technologyわからない
-
Leiden University Medical CenterMedtronic; ZonMw: The Netherlands Organisation for Health Research and Development; Maag Lever... と他の協力者完了
TheraSphereの臨床試験
-
Boston Scientific Corporation募集多形性膠芽腫 | 再発膠芽腫アメリカ
-
Northwestern UniversityBTG International Inc.終了しました
-
University of California, San Franciscoまだ募集していません
-
Boston Scientific Corporation積極的、募集していない
-
University of MiamiImmunocore Ltd募集
-
Southwestern Regional Medical Center完了