Feasibility of the LUM Imaging System for Detection of Peritoneal Surface Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Initial efficacy of LUM015 in labeling peritoneal surface malignancies by molecular imaging by comparing imaging results with pathology
研究概览
简要总结
The objective of this feasibility study is to assess the initial safety and efficacy of the LUM Imaging System for in vivo imaging of metastases to the peritoneum from primary gastrointestinal cancer, ovarian cancer and mesothelioma. This feasibility study consists of a dose escalation phase to select the optimal dose.
详细描述
Subjects will be recruited and screened at a single institution, Massachusetts General Hospital. All subjects will have an established diagnosis of metastases to the peritoneum from primary colonic, appendiceal, or ovarian cancer or mesothelioma and are scheduled for surgical debulking. This study consists of a dose escalation and imaging timepoint evaluation.
18 patients will be enrolled into this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Device Feasibility
- 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
- •Subjects must have histologically or cytologically confirmed metastases to the peritoneum from gastrointestinal cancer, ovarian cancer or mesothelioma prior to surgery.
- •Subjects must be scheduled for surgical resection.
- •Age of 18 years or older.
- •Subjects must be able and willing to follow study procedures and instructions.
- •Subjects must have received and signed an informed consent form.
- •Subjects must be otherwise healthy except for the diagnosis of cancer, as per the criteria listed below.
- •Subjects must have normal organ and marrow function as defined as:
- •Leukocytes > 3,000/mcL
- •Absolute neutrophil count > 1,500/mcL
- •Platelets > 100,000/mcL
- •total bilirubin within normal institutional limits
- •AST (SGOT)/ALT (SGPT) < 2.5 X institutional upper limit of normal
- •Creatinine within normal institutional limits or creatinine clearance > 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal.
- •Subjects with ECOG performance status of 0 or 1.
排除标准
- •Subjects who are pregnant or nursing at the time of diagnosis.
- •Subjects who are sexually active and not willing/able to use medically acceptable forms of contraception (hormonal or barrier method of birth control, abstinence) upon entering the study and for 60 days after injection of LUM
- •Subjects who have taken an investigational drug within 30 days of enrollment.
- •Subjects who have not recovered from adverse events due to other pharmaceutical or diagnostic agents.
- •Subjects with uncontrolled hypertension defined as persistent systolic blood pressure > 180 mm Hg, or diastolic blood pressure > 100 mm Hg; those subjects with known HTN should be under these values while under pharmaceutical therapy.
- •History of allergic reaction attributed to drugs containing polyethylene glycol (PEG).
- •History of allergic reaction to any oral or intravenous contrast agents.
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, COPD or asthma requiring hospitalization within the past 12 months, or psychiatric illness/social situations that would limit compliance with study requirements.
- •HIV-positive individuals on combination antiretroviral therapy are ineligible.
- •Any subject for whom the investigator feels participation is not in the best interest of the subject.
研究组 & 干预措施
1st Tier Dose Level- LUM Imaging System
3 patients will be administered a single dose of LUM015 at 1.0 mg/kg. Imaging with the LUM imaging device will be performed in vivo on surgical tissue.
干预措施: LUM Imaging System (Combination Product)
2nd Tier Dose Level- LUM Imaging System
9 patients will be administered a single dose of LUM015 at 1.5 mg/kg. Imaging with the LUM imaging device will be performed in vivo on surgical tissue. Some patients may be imaged with an additional imaging device.
干预措施: LUM Imaging System (Combination Product)
3rd Tier Dose Level- LUM Imaging System
6 patients will be administered a single dose of LUM015 at 2.0 mg/kg. Imaging with the LUM imaging device will be performed in vivo on surgical tissue. Some patients may be imaged with an additional imaging device.
干预措施: LUM Imaging System (Combination Product)
结局指标
主要结局
Initial efficacy of LUM015 in labeling peritoneal surface malignancies by molecular imaging by comparing imaging results with pathology
时间窗: 1 Day
Correlate the fluorescence levels in tumor tissue imaging to the dose of LUM015 injected.
次要结局
- Number of patients with reported adverse events(up to 5 weeks post surgery)