PET/CT Molecular Imaging of Angiogenesis in Pulmonary or Head and Neck Cancers Prior to or During Chemotherapy Including Agent With Antiangiogenic Effect. A Prospective Multicentric Study of Efficacy and Tolerability.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Response to treatment based on RECIST criterion
研究概览
简要总结
The primary objective of this Phase II study is to evaluate the use of labelled RGD ligand in PET/CT to predict and/or to early assess the efficacy of chemotherapy including an agent with antiangiogenic effect.
The predictive value of this approach will be determined by independent assessors on basis of data at the end of the treatment: RECIST 1.1 criteria for CT or MRI, PERCIST criteria for FDG PET/CT, clinical, endoscopic and histological findings.
详细描述
Prospective, multicentre, open label, phase II clinical trial with diagnostic radiopharmaceutical on efficacy and tolerability of 18F or 68Ga labelled RGD peptide for detection of malignant tissues expressing integrins, to predict the therapeutic response of lesions of advanced head and neck cancer or advanced non-small cells lung cancer to treatment including an agent with antiangiogenic effect.
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
- •1A. Male or female > 18year old with non-small cell lung carcinoma (NSCLC) meeting the following criteria :
- •advanced NSCLC proven by histology or cytology, treatment including an agent with antiangiogenic effect scheduled
- •Measurable lesions > 1 cm in short axis.
- •Pretherapeutic contrast-enhanced CT of thorax and upper abdomen available for masked reading on appropriate medium
- •FDG PET/CT available for masked reading on appropriate medium
- •1B. Male or female > 18year old with head and neck (H&N) cancer meeting the following criteria:
- •advanced H&N cancer proven by histology or cytology, treatment including an agent with antiangiogenic effect scheduled
- •Measurable lesions > 1 cm in short axis.
- •Pretherapeutic native and contrast enhanced CT or MRI of the head and neck available for masked reading on appropriate medium
- •FDG PET/CT available for masked reading on appropriate medium
- •Oto-rhino-laryngologic (ORL) examination including ORL fibroscopy and/or optionally panendoscopy.
- •Capacity to remain without movement during the PET/CT examination
- •ECOG performance status ≤ 2 at inclusion
- •Patient with life expectancy ≥ 24 weeks after inclusion.
- •In fertile females, at inclusion the pregnancy must be ruled out
- •Volunteer and capable to follow necessary instructions during the trial
- •Informed consent signed by the patient
- •Affiliation to a social security system
排除标准
- •In patients with lung cancer: lung cancer with predominance of small-cell or pure bronchioloalveolar cancer.
- •Scheduled treatment which does not include an antiangiogenic agent
- •Patient´s physical condition not permitting participation it clinical trial according to opinion of investigator responsible of the centre
- •Pregnancy or breastfeeding.
研究组 & 干预措施
radiopharmaceutical
PET/CT after intravenous administration of 2-4MBq/kg of body weight of Flotegatide (18F) or RGD (68Ga) performed prior and after 2 cycles of chemotherapy including an agent with antiangiogenic effect (two examinations in each patient)
干预措施: radiopharmaceutical (Flotegatide (18F) or RGD (68Ga) (Drug)
结局指标
主要结局
Response to treatment based on RECIST criterion
时间窗: Pretherapeutic Day-14, Interim Day21
The value of pretherapeutic and interim RGD PET/CT (Pretherapeutic: D -14 to -1 before the initiation of chemotherapy with antiangiogenic agent. Interim : 21 to 1 day before the third cycle of chemotherapy with antiangiogenic agent) to early predict the therapeutic response of head and neck cancer or non-small cell lung cancer to chemotherapy with antiangiogenic agent. Final therapeutic response will be assessed at the end of the treatment, up to 24 weeks after first examination, according to criteria RECIST 1.1. Potential risk for the patient: two intravenous administrations of investigational product (Pretherapeutic : D -14 to -1 before the initiation of chemotherapy with antiangiogenic agent. Interim : 21 to 1 day before the third cycle of chemotherapy with antiangiogenic agent) each of them followed by PET/CT acquisition
次要结局
未报告次要终点