Hypoxic Changes in Hepatocellular Carcinoma (HCC) Following Trans Arterial Chemo Embolization and Stereotactic Radiation: [18F]Fluoromisonidazole (FMISO) Imaging
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Quantitate HCC Tumor Hypoxia at Baseline Using FMISO Positron Emission Tomography (PET).
研究概览
简要总结
[18F] FMISO Positron Emission Tomography (PET) to determine hypoxia in patients with HCC treated with TACE.
详细描述
This Phase II study will investigate the utility of [18F] FMISO in patients with hepatocellular carcinoma (HCC). This trial is designed to test the hypothesis that PET determined [18F]FMISO uptake will indicate tumor hypoxia in patients with HCC treated with trans-arterial chemo-embolization (TACE). We anticipate that [18F] FMISO PET/CT will advance our understanding of the role of hypoxia in HCC prior to treatment and that this knowledge will help design newer combination therapeutic trials for better treatment outcomes. [18F] FMISO PET/CT provides three parameters, tissue hypoxic volume (HV), maximum tissue to blood uptake ratio (T:Bmax) and tumor blood flow. Both pre-and post-therapy images will be examined to investigate changes in these parameters during the course of TACE treatment.
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
- •Adult (> 18 years of age) patients with documented HCC tumor mass >3cm, who are scheduled to undergo TACE with additional selective internal radiation therapy (SIRT)
- •The appropriate criteria for inclusion for this patient population are:
- •Biopsy or radiological diagnosis of HCC (defined as Organ Procurement and Transplantation Network (OPTN*) Category 5 lesion either on CT or MRI)
- •Scheduled for TACE (using doxorubicin-eluting beads) + SBRT
- •Willingness to undergo PET/CT
- •Able to lie on the imaging table for up to 1 hour.
- •Able to provide signed informed consent.
- •Women with childbearing potential must have a negative urine Beta-Human Chorionic Gonadotropin (β-hCG) test day of procedure
排除标准
- •Estimated life expectancy <12 months or serious medical co-morbidities that would preclude definitive local therapy
- •Unable to lie on the imaging table
- •Age less than 18 years.
- •Pregnancy or lactation
- •Inability or unwillingness to provide informed consent.
- •Weight >500 lbs (the weight limit of the tomograph gantry table)
研究组 & 干预措施
FMISO PET imaging post TACE and Stereotactic body radiation therapy (SBRT)
FMISO imaging at baseline, post-TACE and post-SBRT
干预措施: FMISO (Drug)
结局指标
主要结局
Quantitate HCC Tumor Hypoxia at Baseline Using FMISO Positron Emission Tomography (PET).
时间窗: At baseline
Perform PET/CT imaging using FMISO at baseline to measure tumor hypoxia
Measure Changes in HCC Tumor Hypoxia and Blood Flow After Trans-arterial Chemoembolization (TACE), Prior to Radiotherapy.
时间窗: 1 month post-TACE procedures and prior to SBRT
Perform PET/CT imaging using FMISO post-TACE and prior to Stereotactic body radiation therapy (SBRT) to determine tumor hypoxia
Measure Changes in Treated HCC Tumor Hypoxia Following TACE and Radiotherapy
时间窗: 1 month post-SBRT
Perform PET/CT imaging using FMISO post-SBRT to determine tumor hypoxia
次要结局
未报告次要终点
研究者
Janis P. O'Malley, MD
Principal Investigator, Professor of Radiology
University of Alabama at Birmingham