NCT00894101撤回2 期
A Phase II/III, Open Label, Non-Randomized, Multi-Center Study of Positron Emission Tomography Imaging With [F-18] FLT Compared to [F-18] FDG in Cancer Patients for Treatment Evaluation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The basic safety data of [F-18] FLT tracer will be collected. The treatment response evaluated based on the [F-18] FLT results will be compared to the response evaluated based on the standard PET trace [F-18] FDG.
研究概览
简要总结
The purpose of this study is to investigate the clinical value of serial quantitative [F-18] FLT as a PET imaging tool in head and neck cancer patients clinically scheduled with radiation or radiation-chemotherapy combination in terms of safety and efficacy. Standard [F-18] FDG PET will be the active comparator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patient provides written Informed Consent and is willing to comply with protocol requirements
- •Patient is at least 18 years of age on the day of dosing (male or female of any race or ethnicity)
- •Patient is capable of lying still in the PET scanner for the protocol required time frame(s)
- •Patient has a diagnosis of one of the following malignancies (TNM Staging System):
- •Lung cancer (T3 grade up, node positive, but no metastatic disease)
- •Head and neck cancer (T3 grade up, node positive, but no metastatic disease)
- •Patient has undergone a comparative, diagnostic procedure with lesion(s) visible, other than ultrasound, that includes, but is not limited to computed tomography (CT), magnetic resonance imaging (MRI), nuclear medicine imaging, endoscopy, laparoscopy, standard abdominal x-ray, biopsy and/or surgery for one of the above mentioned areas
- •Patient is scheduled to start radiotherapy or a chemoradiotherapy regimen for curative intent
- •As a part of his/her standard radiotherapy or chemoradiotherapy regimen, patient is scheduled to have clinical [F-18] FDG PET scans pre treatment and post treatment (at about 4 weeks (±1 week) after the start of therapy)
- •Patient is scheduled to have the investigational, pre treatment [F-18] FLT PET scan recommended to be within ± 2 days of the clinical, pre treatment [F-18] FDG PET scan
- •Patient has not received or intends to receive 5-fluorouracil (5-FU-chemotherapeutic agent)
- •Patient has a score of greater than or equal to (≥) 60% on the Karnofsky Performance Status Scale
排除标准
- •Exclude a patient from this study if the patient does not fulfill the inclusion criteria, or if any of the following conditions are observed:
- •Patient is a pregnant or lactating female. These methods will be used to exclude the possibility of pregnancy:
- •by testing on site at the institution (serum or urine βHCG) within 48 hours prior to the start of each investigational product administration,
- •by surgical history (eg, tubal ligation or hysterectomy),
- •by patient's history of being post menopausal with a minimum 1 year without menses.
- •Patient is undergoing treatment with palliative intent
- •Patient has received an investigational compound and/or medical device within 14 days before admission into this study
- •Patient has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations
- •Patient is determined by the Investigator that he/she is clinically unsuitable for the study.
研究组 & 干预措施
[F-18] FLT and FDG
Experimental
干预措施: [F-18] FLT (Drug)
结局指标
主要结局
The basic safety data of [F-18] FLT tracer will be collected. The treatment response evaluated based on the [F-18] FLT results will be compared to the response evaluated based on the standard PET trace [F-18] FDG.
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
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