A Pilot Study Assessing the Feasibility and Safety of Measuring Interstitial Fluid Pressure (IFP) in Patients With Advanced Malignant Melanoma Before Starting Systemic Treatment
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Feasibility measured by proportion of patients in whom interstitial fluid pressure (IFP) can be measured
研究概览
简要总结
The goal of this clinical research study is to learn about the side effects of measuring the tumor pressure in patients who have advanced melanoma and have not received chemotherapy. Researchers also want to learn if patients with a lower tumor pressure may respond better to chemotherapy.
详细描述
Tumor Pressure Testing:
If you are found to be eligible to take part in this study, the pressure in up to three tumors will be measured. Medical photography will also be used for documentation if needed.
This will be done in the melanoma outpatient clinic. You will be asked to lie down and the skin over the lesion will be cleaned with betadine (iodine) or a different cleaning agent if you are allergic to iodine. The skin over the lesion will then be numbed with anesthetic. A topical anesthetic is a local anesthetic that is used to numb the surface of a body part. Thirty minutes before the IFP measurement, an EMLA patch (Lidocaine 2.5% and Prilocaine 2.5%) will be applied on the surface of study. Your treating doctor may prescribe a pain drug to help with any discomfort the measurement may cause.
For the tumor measurement, the tip of a needle will be inserted in a skin lesion (similar to a biopsy needle). The needle is connected to a machine that reads the pressure inside the tumor. The measurement itself will take a few seconds. The whole process, including cleaning and numbing the lesion, will take about 3-4 minutes.
You will stay in the clinic and be monitored for side effects for about 1 hour following the tumor measurement.
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
- •Patients with histologic confirmation of malignant melanoma and skin lesion, and/or subcutaneous metastases.
- •Males and Females >/= 18 years of age.
- •Subject is willing and able to comply with scheduled visits and other trial procedures.
- •Patients must be chemo-naive for malignant melanoma. Prior immunotherapy is allowed.
- •Must be scheduled for systemic chemotherapy within 3 weeks of measurements
- •Patient must have at least a one intact tumor or satellite lesion measuring >/= 10 mm in longest diameter.
- •Patients must sign and date an informed consent.
排除标准
- •Major surgery or radiation therapy close to the area where tumor IPF will be measured, within 4 weeks of starting the study treatment.
- •Patients with the only melanoma skin lesions being localized in the area of the head and neck.
- •High risk of bleeding with platelets </= 50,000 microliter, Partial thromboplastin time (PTT)/prothrombin time (PT) > 2 times upper limit of normal or patients on any type of anticoagulation.
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation, or may interfere with the interpretation of study results, and in the judgment of the investigator or his designee would make the subject inappropriate for entry into this study.
- •Patients will be excluded if they are receiving biological agents only.
- •Pregnant or lactating females.
结局指标
主要结局
Feasibility measured by proportion of patients in whom interstitial fluid pressure (IFP) can be measured
时间窗: Baseline only + follow up 3 days after measurement
次要结局
未报告次要终点