NCT02960724Unknown2 期
Phase II Trial: uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- The number of lymph node metastases that can be identified by means of uPAR PET / CT compared with the histological findings.
研究概览
简要总结
uPAR PET/CT for Staging Advanced and Localised oral and oropharyngeal cancer
详细描述
To compare the diagnostic value of uPAR-PET/CT for prognostication compared to the current imaging options (CT, MRI and ultrasound) by observer-blinded readings. The reference that will be used as "gold standard" is the pathological examination of the surgically removed tissues.
The new imaging modality (uPAR-PET/CT) will be used in two separate groups of patients with head and neck cancer:
Study I:
Patients with oral cancer without clinical evidence of spread (OSCC in stage cN0)
Study II:
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand patient information and to give informed consent
- •Not previously irradiated or operated on neck
- •Operable disease
- •Study I OSCC cN0 verified histologically by pathologic examination of biopsy
- •Study II OSCC or OPSCC N + verified histologically by pathologic examination of biopsy
排除标准
- •Pregnancy
- •Patients who are candidates for curative intentional radiation
- •Patients who have had surgery or radiation therapy to the neck as this may alter the lymph drainage.
- •Other diseases assessed by the investigator as basis for exclusion.
- •Age under 18 or over 85 years
- •Obesity> 140 kg
- •Allergy to 68Ga-NOTA-AE105
结局指标
主要结局
The number of lymph node metastases that can be identified by means of uPAR PET / CT compared with the histological findings.
时间窗: Through study completion, an average of 1.5 year
次要结局
- Evaluation of the correlation between tumor burden (assessed v.h.a. TNM staging) uPAR-PET signal (assessed as SUVmax) and the amount of uPAR metabolites in plasma.(Through study completion, an average of 1.5 year)
- Determination of the lower detection limit of the amount of tumor tissue for uPAR-PET correlated with the histological H-score x tumor size (where tumor size is evaluated on the pathological preparation of pathologist)(Through study completion, an average of 1.5 year)
- Evaluation of the correlation between uPAR PET signal (quantified as SUVmax) and the immunohistochemical expression of uPAR evaluated by an H-score (intensity x the percentage of stained tumor tissues throughout the tumor margin).(Through study completion, an average of 1.5 year)
研究者
Kirstine Karnov
MD, PhD-student
Rigshospitalet, Denmark
研究点 (2)
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