Utilizing Parenchymal Blood Volume Imaging to Assess Changes in Hepatocellular Carcinoma Perfusion as Potentiated by Intra-Arterial Nitroglycerin
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Proportion of Participants with >= 30% increase in Tumoral Blood Volume
研究概览
简要总结
This is a single-arm, open-label, single-center, first-in-human feasibility study evaluating parenchymal blood volume (PBV) imaging as a tool to dynamically assess perfusional changes in hepatocellular carcinoma (HCC) potentiated by intra-arterial administration of nitroglycerin.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 m
- •Liver function: Child-Pugh score must be no higher than B
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Nitroglycerin (Drug)
结局指标
主要结局
Proportion of Participants with >= 30% increase in Tumoral Blood Volume
时间窗: 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.
次要结局
- Proportion of Participants with >= 50% increase in Tumor-to-Normal Ratio(Day 1)