A Pilot Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide (99mTc-GP) in Patients With Breast Cancer
试验速览
- 阶段
- 1 期
- 发起方
- SeeCure LLC
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- To determine the best dose of 99mTc-GP in imaging based upon safety data and tumor-to background (T/B) count density ratios.
研究概览
简要总结
The purpose of this study is to evaluate the biodistribution and dosimetry of single dose of 99mTc-glycopeptide (99mTc-GP, 20-25 mCi) in 3 different doses of GP (5, 10and 20 mg)in patients with breast cancer at pre-chemotherapy.
详细描述
Cohorts of 3 will be treated each at different dose levels and images will be taken at 4 time points. For dosimetry estimates, there will be a 20-24 hr time point post-administration of 99mTc-GP for the first 3 patients. If the biodistribution and dosimetry can be adequately quantified without the 20-24 hr scan in 3 patients, then we will eliminate that 4th scan for all other patients. Urine and blood samples will be collected at 5 time points, and an additional blood and urine sample will be collected for dosimetry analysis at 30~60 min.
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
- •Patients with newly diagnosed stage I-IV breast cancer (tumor size
- •2cm in imaging examinations) who are scheduled to start systemic therapy.
- •Patients must have histological diagnosis of invasive breast cancer.
- •Extent of disease will be determined by physical examination and conventional radiological studies.
- •Must be age 18 or older.
- •ECOG performance status 0-
- •Patients with history of prior malignancies must be disease-free for at least 5 years of study entry.
- •Normal hematological function: WBC > 3000/ul, absolute neutrophil count > 1500/ul, platelets > 100,000/ul, and Hgb > 10 gms (transfusion to achieve Hgb > 10 gms is acceptable).
- •Serum total bilirubin < 1.5 mg/dl and SGPT < 1.5 X normal.
- •Adequate kidney function (creatinine < 1.5 mg/dL).
排除标准
- •Patients who received previous chemotherapy for the newly diagnosed breast cancer.
- •No evidence of primary breast lesion (e.g. T0, Tx).
- •Pregnant women or sexually active women of childbearing potential who are not practicing adequate contraception are excluded.
- •Patients with myocardial infarction within 6 months of study entry; unstable angina pectoris; uncontrolled congestive heart failure; uncontrolled arrhythmia are excluded.
- •Patients with history of hypersensitivity/allergy to Chitosan/Chitin related shellfish foods.
结局指标
主要结局
To determine the best dose of 99mTc-GP in imaging based upon safety data and tumor-to background (T/B) count density ratios.
时间窗: from 99mTc-GP injection through 30 days
次要结局
- To determine the optimal time to imaging after injection of 99mTc-GP based upon tumor to-background (T/B) count density ratios at various times.(from 99mTc-GP injection through 30 days)