Defining the Ablative Dose for Y-90 TARE (MARGIN)
2026年9月10日 更新者：Andrew Gordon、Northwestern University
A Prospective Dose-Escalation Study to Define an Ablative Dose of Yttrium-90 Transarterial Radioembolization Using Advanced Dosimetry and Functional MRI (MARGIN Study)
This study is being done to help doctors improve how they treat liver tumors that cannot be removed by surgery or treated with standard ablation techniques.
The researchers want to find out the best amount of radiation that needs to be delivered to completely destroy (or ablate) parts of the liver that have cancer.
調査の概要
詳細な説明
Currently, doctors use Yttrium-90 (Y90) radiation segmentectomy, a treatment that delivers tiny radioactive beads into the blood vessels feeding the liver tumor. These beads give off radiation that helps kill the cancer cells from the inside, right where the tumor is located. This approach allows doctors to target the tumor very precisely, while keeping the rest of the liver as healthy as possible. However, the exact dose needed to fully ablate a tumor without damaging healthy liver tissue is not well established.
To answer this, the study team will use specialized imaging before and after treatment to evaluate how the radiation is distributed in the liver and how the liver responds over time. These imaging procedures include PET/CT or PET/MRI scans, which are standard medical imaging tests that are not considered experimental. During these scans, a small amount of a safe radioactive substance is injected into a participant's vein. This helps show where the Y90 beads are located in the participant's liver.
In a PET/CT scan, two types of imaging are performed during the same session. The PET scan detects signals from the radioactive substance and shows how the participant's liver is functioning at a molecular level. The CT scan, which uses x-rays to create detailed cross-sectional images of the body, provides a precise anatomical map that helps localize these functional signals. Together, they give a clear picture of both the structure and activity within the liver.
PET/MRI works similarly but uses magnetic fields and radio waves instead of x-rays. It combines the functional information from the PET scan with the highly detailed soft-tissue images from MRI, which can be especially useful in evaluating the liver. Both imaging techniques are done during a single visit, with the PET component typically performed at the same time as the CT or MRI, depending on which machine is used. Participants will also undergo a liver MRI with dual contrast using Eovist and extracellular gadolinium, another standard imaging procedure. MRI uses magnets and radio waves to take detailed pictures of the liver. Eovist is a special dye injected into a participant's vein during the scan that helps highlight liver tissue and shows how well different parts of the liver are functioning. Extracellular gadolinium is a more general contrast agent that enhances blood vessels and tissues, providing complementary information. This imaging helps the doctors confirm whether the tumor area was completely treated.
The goal is to determine the safest and most effective dose of radiation to fully treat cancer while preserving healthy liver tissue. This information may help doctors treat future patients more precisely and safely.
Yttrium-90 and the imaging methods used in this study, including PET/CT, PET/MRI, and dual contrast MRI, are FDA-approved.
研究の種類
介入
入学 (推定)
30
段階
- フェーズ2
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。
研究連絡先
- 名前：Andrew C Gordon, MD, PhD
- 電話番号：(561)703-0134
- メール：andrew.gordon@nm.org
研究連絡先のバックアップ
- 名前：Saad Abu Zahra, MD
- 電話番号：646-996-2817
- メール：saad.abuzahra@northwestern.edu
研究場所
-
-
Illinois
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Chicago、Illinois、アメリカ、60611
- 募集
- Northwestern University
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コンタクト：
- Andrew C Gordon, MD, PhD
- 電話番号：(561)703-0134
- メール：andrew.gordon@nm.org
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主任研究者：
- Andrew C Gordon, MD, PhD
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副調査官：
- Robert J Lewandowski, MD, FSIR
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副調査官：
- Amir A Borhani, MD
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副調査官：
- Saad E Abu Zahra, MD
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コンタクト：
- Saad Abu Zahra, MD
- 電話番号：646-996-2817
- メール：saad.abuzahra@northwestern.edu
-
-
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
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Diagnosis of hepatocellular carcinoma (HCC), cholangiocarcinoma, or liver-dominant metastatic disease not amenable to surgical resection or ablation.
- Age ≥18 years.
- Child-Pugh class A or B liver function
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Adequate organ and bone marrow function as defined below:
- Leukocytes (WBC) ≥ 3,000/mcL
- Absolute neutrophil count (ANC) ≥ 1,500/mcL
- Hemoglobin ≥ 9 g/dL
- Platelets ≥ 50,000/mcL
- Total bilirubin ≤ 3.0 mg/dL
- AST ≤ 100 U/L, ALT ≤ 120 U/L
- Creatinine ≤ 2.0 mg/dL or estimated GFR ≥ 40 mL/min/1.73 m²
- Ability to undergo imaging and laboratory evaluations required by the study.
- Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
- Extrahepatic metastases.
- Pregnant or breastfeeding individuals.
- Tumors requiring treatment of more than two Couinaud segments.
- Known hypersensitivity to gadolinium-based contrast agents.
- Contraindications to MRI (e.g., incompatible pacemakers, claustrophobia unresponsive to sedation).
- Coagulopathy or clinical instability precluding angiographic intervention.
- Prisoners or individuals under legal custody.
- Adults unable to consent.
- Individuals under 18 years of age.
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：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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アクティブコンパレータ：Cirrhotic
Cirrhotic patients will begin at 300 Gy.
Dose escalation will proceed in 100 Gy increments within each arm, with safety continuously evaluated by the Data Safety Monitoring Committee
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The objective of this study is to define an optimal "ablative dose" range for Y90 Radiation Segmentectomy that achieves complete sectoral ablation detectable on dual contrast MRI and to determine whether this dose-response relationship differs between cirrhotic and non-cirrhotic patients.
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アクティブコンパレータ：Non-cirrhotic
Non-cirrhotic patients will begin at a dose of 200 Gy.
Dose escalation will proceed in 100 Gy increments within each arm, with safety continuously evaluated by the Data Safety Monitoring Committee.
|
The objective of this study is to define an optimal "ablative dose" range for Y90 Radiation Segmentectomy that achieves complete sectoral ablation detectable on dual contrast MRI and to determine whether this dose-response relationship differs between cirrhotic and non-cirrhotic patients.
|
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 |
|---|---|---|
|
Ablative Dose Threshold for Y90 Radiation Segmentectomy
時間枠：From enrollment to the end of post-treatment Y90 12 month follow up visit
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To prospectively define the "ablative dose" threshold for Y90 Radiation Segmentectomy (RS) using post-treatment PET dosimetry and hepatobiliary phase MRI
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From enrollment to the end of post-treatment Y90 12 month follow up visit
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Impact of Cirrhosis on Ablative Dose Requirements
時間枠：From enrollment to enrollment to post-treatment Y-90 12 month follow-up visit
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To determine whether cirrhotic patients require a higher threshold dose for ablation compared to non- cirrhotic patients
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From enrollment to enrollment to post-treatment Y-90 12 month follow-up visit
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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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Correlation of Y90 Dose with Imaging Biomarkers
時間枠：Assessed at 1, 4-9, and 12 month follow up visits
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To evaluate the correlation between delivered Y90 dose and imaging biomarkers, including signal loss on hepatobiliary phase MRI, ablative margins, extracellular volume fraction, and perfusion changes
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Assessed at 1, 4-9, and 12 month follow up visits
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Tumor Response and Time-to-Progression Assessment
時間枠：From enrollment to end of post-treatment Y-90 12 month follow up visit
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To assess tumor response by mRECIST and determine time to progression (TTP)
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From enrollment to end of post-treatment Y-90 12 month follow up visit
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Safety and Tolerability of Escalating Y90 Doses
時間枠：From enrollment to end of post-treatment Y90 12 month follow up visit
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To assess the safety and tolerability of escalating segmental Y90 doses (200- 500 Gy) using Bayesian optimal interval (BOIN) dose-escalation design under Data and Safety Monitoring Committee (DSMC) oversight
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From enrollment to end of post-treatment Y90 12 month follow up visit
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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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Pathologic Necrosis in Explanted Tumors
時間枠：From enrollment to end of post-treatment Y90 12 month follow-up visit
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To evaluate complete pathological necrosis in explanted tumors from patients who undergo liver resection or transplantation
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From enrollment to end of post-treatment Y90 12 month follow-up visit
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Early Imaging Biomarkers for Ablation Success
時間枠：From enrollment to post-treatment Y90 12 month follow-up visit
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To identify novel early imaging biomarkers (Eovist hepatobiliary phase defects, extracellular volume mapping, perfusion changes) that may serve as surrogates for ablation success
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From enrollment to post-treatment Y90 12 month follow-up visit
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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。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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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 (実際)
2026年5月15日
一次修了 (推定)
2029年2月1日
研究の完了 (推定)
2029年5月1日
試験登録日
最初に提出
2026年5月7日
QC基準を満たした最初の提出物
2026年5月7日
最初の投稿 (実際)
2026年5月14日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月15日
QC基準を満たした最後の更新が送信されました
2026年9月10日
最終確認日
2026年5月1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。