Utilize Imaging to Assess Changes in Hepatocellular Carcinoma Perfusion as Potentiated by Intra-Arterial Nitroglycerin
Utilizing Parenchymal Blood Volume Imaging to Assess Changes in Hepatocellular Carcinoma Perfusion as Potentiated by Intra-Arterial Nitroglycerin
調査の概要
状態
条件
詳細な説明
PRIMARY OBJECTIVES:
I. Evaluate in vivo, parenchymal blood volume imaging's ability to dynamically assess blood flow to hepatocellular carcinoma.
SECONDARY OBJECTIVES:
1. Quantitative measurement of tumor perfusion after intra-arterial injection of nitroglycerin using parenchymal blood volume imaging.
OUTLINE:
Participants will undergo parenchymal blood volume (PBV) imaging before and after intra-arterial nitroglycerin injection during their standard transarterial chemoembolization (TACE) treatment. Participants will be followed on days 3, 7, 30, and 90 after the procedure.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前:Diana Flores
- 電話番号:415-514-6221
- メール:diana.flores@ucsf.edu
研究場所
-
-
California
-
San Francisco、California、アメリカ、94143
- University of California, San Francisco
-
コンタクト:
- 電話番号:877-827-3222
- メール:cancertrials@ucsf.edu
-
コンタクト:
- Diana Flores
- 電話番号:415-514-6221
- メール:diana.flores@ucsf.edu
-
主任研究者:
- Christopher Brunson, MD
-
San Francisco、California、アメリカ、94110
- Zuckerberg San Francisco General Hospital (ZSFG)
-
コンタクト:
- 電話番号:877-827-3222
- メール:cancertrials@ucsf.edu
-
コンタクト:
- Diana Flores
- 電話番号:415-514-6221
- メール:diana.flores@ucsf.edu
-
主任研究者:
- Christopher Brunson, MD
-
-
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
説明
Inclusion Criteria:
- Participants must have radiographically documented, previously untreated LIRADS V liver lesions or biopsy-confirmed hepatocellular carcinoma (HCC), as determined by the ZSFG Liver Tumor Board.
- Lesions must be determined to be suitable for conventional trans-arterial chemoembolization (cTACE) based on multidisciplinary tumor board review.
- No prior locoregional therapy (e.g., TACE, Y-90) to the index lesion(s).
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Karnofsky >70%)
Demonstrates adequate organ function as defined below:
- Absolute neutrophil count >=1,500/microliter (mcL).
- Platelets ≥100,000/microliter (mcL).
- Total bilirubin ≤ 3.0 milligrams per deciliter (mg/dL), unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits.
- Aspartate aminotransferase (AST) / serum glutamic-oxaloacetic transaminase (SGOT) ≤3 X institutional upper limit of normal.
- Alanine aminotransferase (ALT) / serum glutamic-oxaloacetic transaminase (SGPT) ≤3 X institutional upper limit of normal
- Creatinine ≤ 1.5 x within institutional upper limit of normal or
- Creatinine clearance Glomerular filtration rate (GFR) >= 60 milliliters per minute (mL/min)/1.73 m2, calculated using the Cockcroft-Gault equation, unless data exists supporting safe use at lower kidney function values, no lower than 30 milliliters per minute (mL/min)/1.73 m2.
- Liver function: Child-Pugh score must be no higher than B5.
- Ability to understand and the willingness to sign a written informed consent document.
- Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- The female participants of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception during the study and for 30 days after study intervention.
Exclusion Criteria:
- Multifocal disease (i.e., presence of more than one HCC lesion).
- Has received systemic anticancer therapies within 3 weeks of first dose, radiation within 2 weeks, antibody therapy within 4 weeks. Concomitant administration of LHRH analogues for prostate cancer and somatostatin analogues for neuroendocrine tumors are allowed as per standard of care.
- Has not recovered from adverse events due to prior anti-cancer therapy to ≤ grade 1 or baseline (other than alopecia).
- Is currently receiving any other therapeutic/investigational agents.
- Has participated in a study of an investigational product and received study treatment or used an investigational device within 3 weeks of the first use of an investigational product.
- Co-morbid disease or concurrent illness (e.g., cardiovascular disease, portal vein thrombosis).
- Hypersensitivity to nitroglycerine or any of its excipients.
Concomitant medications (contraindicated):
- Concurrent use of prescription phosphodiesterase inhibitors (e.g., sildenafil)
- Concurrent use of nitrate-containing medications.
- Concurrent use of vasoactive chemotherapeutic agents, such as bevacizumab (Avastin).
Recent anti-cancer therapies:
- Systemic anticancer therapies within 3 weeks of the procedure.
- Radiation therapy within 2 weeks.
- Antibody-based therapy within 4 weeks.
- Use of investigational agents or devices within 3 weeks of the index procedure.
- Unresolved toxicities from prior cancer therapy, unless ≤ Grade 1 (excluding alopecia).
- Currently receiving any other therapeutic or investigational agents during the study period.
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:Nitroglycerin Injection
Participants with confirmed hepatocellular carcinoma (HCC) will undergo parenchymal blood volume (PBV) imaging before and after intra-arterial nitroglycerin injection during standard transarterial chemoembolization (TACE) treatment.
Nitroglycerin doses ranging from 200-300 micrograms will be administered based on patient body mass index (BMI) and interventional radiology standards.
Participants will be followed either in person or via telehealth on days 3, 7, 30, and 90 for safety and post-procedural assessment, until withdrawal from the study or death, whichever occurs first.
|
Undergo imaging
他の名前:
Given Intra-Arterially
Data will be collected from the participant medical records.
他の名前:
|
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 |
|---|---|---|
|
Proportion of Participants with >= 30% increase in Tumoral Blood Volume
時間枠:Day 1
|
Proportion of participants who demonstrate an increase in tumoral blood volume of at least 30% following intra-arterial nitroglycerin administration compared with pre-nitroglycerin baseline along with Bonferroni-corrected confidence intervals will be reported.
|
Day 1
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of Participants with >= 50% increase in Tumor-to-Normal Ratio
時間枠:Day 1
|
Proportion of participants demonstrating at least a 50% increase in the tumor-to-normal ratio on parenchymal blood volume imaging following intra-arterial nitroglycerin administration compared with pre-nitroglycerin baseline along with Bonferroni-corrected confidence intervals will be reported.
|
Day 1
|
協力者と研究者
捜査官
- 主任研究者:Christopher Brunson, MD、University of California, San Francisco
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
追加の関連 MeSH 用語
その他の研究ID番号
- 26323
- NCI-2026-04001 (レジストリ識別子:NCI Clinical Trials Reporting Program (CTRP))
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
米国で製造され、米国から輸出された製品。
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