Characterizing Tumor Hypoxia With BOLD-MRI to Predict Y-90 Treatment Response (BOLDMRI)
Characterization of the Hypoxic Tumor Microenvironment With Blood Oxygen Level-Dependent Magnetic Resonance Imaging for the Prediction of Hepatocellular Carcinoma Response to Yttrium-90 Selective Internal Radiation Therapy
The purpose of this study is to find out whether a special type of magnetic resonance imaging ( MRI), called blood oxygen level-dependent (BOLD) MRI, can help measure how much oxygen is present in liver tumors. Tumors with low oxygen levels are described as being hypoxic.
Yttrium-90 (Y-90) is a type of radioactive material used to treat liver tumors, including hepatocellular carcinoma (HCC), a type of liver cancer. Y-90 is a form of radiation treatment delivered directly to liver tumors through tiny beads carried by blood vessels. These beads release radiation that damages and kills cancer cells while helping limit radiation exposure to surrounding healthy tissue. This treatment is also called Y-90 radioembolization or selective internal radiation therapy (SIRT).
調査の概要
状態
詳細な説明
The study will include 12 patients with liver tumors confirmed by biopsy to be hepatocellular carcinoma (HCC), a type of liver cancer, who are scheduled to receive Y-90 selective internal radiation therapy (SIRT), a treatment that delivers radiation directly to the tumor through blood vessels. Before treatment, participants will undergo a research MRI scan. A sample of their previously biopsied tumor tissue will also be examined in the laboratory to measure signs of low oxygen levels. The researchers will compare the MRI findings with the tissue results to determine whether BOLD MRI can reliably assess oxygen levels in liver tumors and may help predict how well the tumors respond to Y-90 treatment.
Standard-of-care Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE MRI) will be performed separately according to routine clinical practice before and after the Y90-SIRT procedure. BOLD MRI will be performed on a separate day after the pre-SIRT DCE MRI.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Markeela Lipscomb
- 電話番号：919-972-7440
- メール：markeela_lipscomb@med.unc.edu
研究連絡先のバックアップ
- 名前：Kaila Brustkern
- 電話番号：984-974-3226
- メール：kaila_brustkern@med.unc.edu
研究場所
-
-
North Carolina
-
Chapel Hill、North Carolina、アメリカ、27599
- UNC Lineberger Comprehensive Cancer Center
-
コンタクト：
- Markeela Lipscomb
- 電話番号：919-972-7440
- メール：markeela_lipscomb@med.unc.edu
-
コンタクト：
- Kaila Brustkern
- 電話番号：984-974-3226
- メール：kaila_brustkern@med.unc.edu
-
主任研究者：
- Alexander Villalobos, MD
-
主任研究者：
- Bryan Harris, MD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
Subjects must meet all the inclusion criteria to participate in this study.
- Adults ≥ 18 years
- Liver mass(es) suspected of being HCC by imaging and are amenable to undergo percutaneous liver mass biopsy to confirm the HCC diagnosis, as determined by the institutional multidisciplinary tumor board.
- At least 1 tumor ≥ 2 cm and deemed to benefit from Y90 radioembolization by the institutional multidisciplinary tumor board.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky Performance Status (KPS) ≥60%)
- Life expectancy ≥6 months, as determined by the investigator.
Exclusion Criteria:
All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation.
- Definite liver transplant candidate
- Concurrent secondary malignancy
- Distant metastasis
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
- 主な目的：診断
- 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 |
|---|---|
|
実験的：Hepatocellular carcinoma
Patients with hepatocellular carcinoma (HCC) who are scheduled to receive Y-90 selective internal radiation therapy (SIRT), |
BOLD MRI will include 2D and 3D multi-echo gradient-echo sequences covering the liver, using body phased-array coils and breath-hold techniques. Imaging parameters may be adjusted as needed to optimize tumor visualization while maintaining data quality. |
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 |
|---|---|---|
|
The number of successful novel blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI)
時間枠：Baseline
|
The number of successful novel blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI) method for evaluating the level of tumor tissue hypoxia in patients with liver tumors. |
Baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Hepatocellular carcinoma (HCC) hypoxia classification based on blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI)
時間枠：Baseline
|
Calculation of sensitivity, specificity, positive predictive value and negative predictive value of blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI) based hepatocellular carcinoma (HCC) hypoxia classification. |
Baseline
|
協力者と研究者
捜査官
- 主任研究者：Alexander Villalobos, MD、UNC Lineberger Comprehensive Cancer Center
- 主任研究者：Bryan Harris, MD、UNC Lineberger Comprehensive Cancer Center
出版物と役立つリンク
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
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- LCCC2446
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?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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