NCT06083896招募中1 期
Minimally-invasive Stabilization of Pelvic Metastases With Photodynamic Nails: A Multi-center Prospective Study of Functional Outcome
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
研究概览
简要总结
Determine whether patients exhibit early functional improvement after minimally-invasive placement of Illuminoss photodynamic nails for peri-acetabular pelvic metastasis at 3 months following procedure
详细描述
Primary Objectives
1. Evaluate whether patients exhibit early functional improvement after minimally-invasive placement of Illuminoss photodynamic nails for peri-acetabular pelvic metastasis at 3 months following procedure
Secondary Objectives
- Evaluate whether the procedure relieves pain
- Evaluate radiographic stability of the implant
- Evaluate functional outcome at earlier time points (2 weeks or 6 weeks) and at 6 months and possibly later time points
- Evaluate reoperation rate and complications
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Patients must have a histologically confirmed malignancy from prior biopsy of the primary tumor or a metastatic site. Patients with carcinoma, myeloma, and lymphoma may be included in the study. Patients should have metastatic involvement of the periacetabular region that is visible radiographically. Biopsy of acetabular disease is not required for this study.
- •Age ≥18 years (Illuminoss is approved only for skeletally mature patients)
- •Suitable candidate for general anesthesia
- •Ability to understand and the willingness to sign a written informed consent document.
- •Able and willing to fill out pre-operative and post-operative functional outcome surveys
- •Absolute neutrophil count ≥ 1,500/mcL
- •Platelets ≥ 50,000/mcL
排除标准
- •Patients with uncontrolled intercurrent illness (e.g., recent pneumonia or myocardial infarction that would significantly increase risk of general anesthesia)
- •Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- •Patients with psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant women are excluded from this study because of the risk of general anesthesia and radiation exposure (fluoroscopy) to the fetus
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to dental resins or PET.
结局指标
主要结局
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
时间窗: Through study completion, up to one year
次要结局
未报告次要终点
研究者
研究点 (1)
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