A Contiguous, Sequential Phase I/II Imaging Study of 18F-fluoro-3'-L-fluorothymidine (18F-FLT) in Patients With Known or Suspected Carcinoma of the Lung, Breast, Renal Cell, Pancreas, or Brain, and With Gastrointestinal Malignancies, Neuroendocrine Tumours or Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Phase II: To determine general biodistribution of 18F-FLT and correlate 18F-FLT uptake with hENT1 expression and Ki-67 scores.
研究概览
简要总结
The Radiotracer 18F-FLT can non-invasively assess excessive cell growth in PET scan images. Tumour growth rate is a useful indicator of tumour aggression and response to treatment. Imaging and measuring the cell growth with 18F-FLT may be useful in monitoring response to anticancer treatment.
详细描述
Clinical trial is a combined Phase I/II imaging, open label, single site study in patients with known or suspected carcinoma of the lung, breast, renal cell, pancreas or brain, and with gastrointestinal malignancies, neuroendocrine tumours, or lymphoma. One 18F-FLT PET scan will be performed in 10 Phase I patients, and pre-injection and post-imaging blood work and vital signs will be collected. Up to 5 18F-FLT PET scans will be performed in 170 Phase II patients.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female greater than or equal to 16 years of age. If female of child-bearing potential and outside of the window of 10 days since the first day of last menstrual period, a negative pregnancy test is required.
- •Patients with known primary or suspected primary, recurrent or metastatic carcinoma of the lung, breast, renal cell, pancreas or brain (including GGM, oligodendrogliomas, and brain metastases from any primary tumour) and with gastrointestinal malignancies, neuroendocrine tumours (including carcinoid and islet cell malignancies, or lymphoma, with at least one lesion >1 cm in diameter.
- •Biochemical parameters as measured are required to be within 5 times the normal limits for age.
- •Able and willing to follow instruction and comply with the protocol
- •Provide written informed consent prior to participation in the study
- •Karnofsky Performance Scale Score 50-100
排除标准
- •Previous removal of entire tumour
- •Biochemical parameters as measured outside 5 times the normal limits for age
- •Unable or unwilling to follow instructions and comply with the protocol
- •Unable or unwilling to provide written informed consent prior to participation in the study
- •Karnofsky Performance Scale Score < 50
- •Nursing or pregnant females
- •Age less than 16 years
研究组 & 干预措施
1
18F-FLT PET
干预措施: 18F-FLT (Biological)
结局指标
主要结局
Phase II: To determine general biodistribution of 18F-FLT and correlate 18F-FLT uptake with hENT1 expression and Ki-67 scores.
时间窗: 3 years
Phase I: to determine the safety of 18 F-FLT.
时间窗: 3 years
次要结局
- Phase I: To determine general biodistribution of 19F-FLT(3 years)
- Phase II: to confirm safety of 18F-FLT; to determine the relative uptake of 18F-FLT (SUV, RUS, T/N); and to correlate 18F-FLT uptake with patient outcomes.(3 years)
- Phase II: to correlate 18F-FLT uptake with patient outcomes (treatment response, progression-free survival, overall survival), over the first 12 months of follow-up after completion of tx, subsequently over the remainder of the disease course(3 years)