A Phase II/III, Open Label, Non-Randomized, Multi - Center Study Of Positron Emission Tomography (PET) Imaging With [F-18] FLT Compared to [F-18] FDG in Cancer Patients for Treatment Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- [F-18]FLT PET Scan for Early Assessment of Tumor Response to Radiation or Chemoradiotherapy Compared to [F-18] FDG PET Scan
研究概览
简要总结
Approximately 60 patients will be enrolled with highly suspected lung cancer, or head and neck cancer. The patients must also be starting radiotherapy or a chemoradiotherapy regimen (except with 5-fluorouracil). The patients will undergo 3 visits. One screening, one pre therapy PET/CT imaging visit, and one (3-5 weeks after the start of therapy) post PET/CT imaging visit. This study will evaluate the FLT and FDG images for tumor proliferation rates for early assessment of tumor response to radiation or chemo-radiation combo.
详细描述
PHASE: II/III
OBJECTIVES:
Primary: To investigate the clinical value of serial quantitative [F-18] FLT positron image assessment of tumor proliferation rates for early assessment of tumor response to radiation or chemoradiotherapy regimens (except with 5-fluorouracil) in comparison to serial quantitative [F-18] FDG images
Secondary: To gain additional clinical information and experience with [F-18]FLT to guide the design of a future, pivotal, Phase III trial where changes in tumor proliferation from pre-treatment baseline values can be used as a early indicator of response to therapy regimens.
DESIGN: Open label, nonrandomized, uncontrolled, single group assignment
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
- •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 using the 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 (chemotherapeutic agent)
- •Patient has a score of greater than or equal to (>/=) 60% on the Karnofsky Performance Status Scale
排除标准
- •Patient is a pregnant or lactating female. 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
FLT PET scan
Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate [F-18] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard [F-18] FDG PET will be the active comparator.
干预措施: [F-18]FLT (Drug)
结局指标
主要结局
[F-18]FLT PET Scan for Early Assessment of Tumor Response to Radiation or Chemoradiotherapy Compared to [F-18] FDG PET Scan
时间窗: 3-5 weeks after the start of radiation or chemo radio therapy
The sponsor decided not to further develop \[F-18\]FLT. Therefore, no further analysis was performed.
次要结局
未报告次要终点