NCT03998566已完成不适用
Early Feasibility Study For Evaluation Of The TraceIT® Tissue Spacer For Creating Space Between The Duodenum And Pancreas In Patients With Localized Pancreatic Cancer Undergoing Radiation Therapy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- Safety Endpoint
研究概览
简要总结
An early feasibility study to evaluate feasibility, radiotherapy benefits and safety when using TraceIT tissue spacer to create space between pancreas and duodenum in patients with localized Pancreatic Cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Age ≥18 years old
- •Biopsy-confirmed localized pancreatic cancer in the head or neck of the pancreas as defined by the NCCN guidelines
- •Tumor is clearly delineable from duodenum and no clear evidence of invasion of the duodenum is seen at time of EUS performed for either diagnosis or fiducial placement.
- •Subject is able to comply with motion management guidelines.
- •Radiotherapy or chemoradiotherapy for treatment of the disease is indicated.
- •In Investigator's opinion, medically fit to undergo endoscopy for fiducial marker implantation and TraceIT administration.
- •Subjects Screening/Baseline laboratory testing must meet the following laboratory value criteria:
- •White blood cell count: ≥ 3.0 x 109/L
- •Absolute neutrophil count (ANC): ≥ 1.5 x 109/L
- •Platelets: ≥ 100 x 109/L
- •Total bilirubin: ≤ 2.0 times upper limit of normal (ULN)
- •AST and ALT: ≤ 3.0 times institutional upper normal limit
- •Serum creatinine: < 1.5 times ULN e
- •INR: < 1.5
- •Serum pregnancy: Negative
- •Hemoglobin: ≥ 8.0 g/dl
- •Zubrod Performance Status 0-2
- •Subject or authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site.
- •Life expectancy of at least 9 months
排除标准
- •Patients for whom radiotherapy is contraindicated
- •Previous thoracic or abdominal radiotherapy
- •Any GI abnormality that would interfere with the ability to access the injection site
- •Presence of tumor invasion of the duodenum detected on EUS at time of biopsy
- •Previous Whipple procedure or other resection of pancreatic tumor prior to screening
- •Active gastroduodenal ulcer or uncontrolled watery diarrhea
- •History of Chronic Renal Failure.
- •Documented history of uncontrolled diabetes (i.e., symptomatic hyperglycemia that cannot be medically managed, fasting blood glucose level above 300 mg/dL, and/or frequent swings between hyperglycemia and hypoglycemia)
- •Currently enrolled in another investigational drug or device trial that clinically interferes with this study.
- •Unable to comply with the study requirements or follow-up schedule.
- •Any condition or comorbidity that the Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the subject.
- •Women who are pregnant or breast-feeding; women of child-bearing age must use contraceptives.
研究组 & 干预措施
TraceIT Tissue Spacer
Experimental
干预措施: TraceIT Tissue Spacer implantation (Device)
结局指标
主要结局
Safety Endpoint
时间窗: 2-6 week assessment post-procedure
Number of subjects with TraceIT procedure-related event which resulted in a delay in initiation for RT (radio-therapy).
次要结局
- Progression Free and Overall Survival(18 months post procedure)
- Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30)(Changes in baseline at the Final RT appointment, 3 month, 6 month, 12 month and 18 month)
- Radio-Therapy Benefits of TraceIT(2-6 week assessment)
- Feasibility of TraceIT(2-6 week assessment post-procedure)
- TraceIT Persistence (at 6-months Post-treatment)(2-6 weeks and 6 month post procedure)
- Theoretical Dose Escalation From Post-TraceIT Treatment Plan(2-6 week assessment Post-procedure)
- Incidence of Resection Following the Completion of Radiation Therapy (RT)(2-6 weeks post procedure)
- Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing(18 months post procedure)
研究者
研究点 (3)
Loading locations...
相似试验
招募中
不适用
MMA Embolization for Refractory Chronic MigraineMigraine DisordersNCT06735833Cerenovus, Part of DePuy Synthes Products, Inc.70
已完成
1 期
Radiotherapy to the Prostate and Dominant Intra-Prostatic Lesion (DIL)Prostate CancerNCT03269422Memorial Sloan Kettering Cancer Center35
已完成
1 期
Using Intensity-Modulated Radiation Therapy to Permit Sparing of Parotid Gland FunctionHead and Neck CancerNCT00137475AHS Cancer Control Alberta130
撤回
1 期
Feasibility and Safety Study Using Preoperative High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy at High-Risk for Extraprostatic CancerProstate CancerNCT01163448Memorial Sloan Kettering Cancer Center
招募中
1 期
A Study of an Alternative Treatment Approach (Preoperative Radiotherapy, Then Mastectomy, Then Immediate Reconstruction Surgery) in People With T4 Breast CancerInvasive Breast CancerBreast CancerNCT05412225Memorial Sloan Kettering Cancer Center60