EUCTR2022-001361-12-DK进行中（未招募）1 期
An open-label, non-randomized, single center, single dose, exploratory phase II trial of FG001 (an imaging agent) for localization of oral and oropharyngeal squamous cell carcinoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Naive subjects with primary biopsy-proven squamous cell carcinoma (with or without metastaseis) of the oral cavity or oropharynx eligible for resection of the primary tumor at the trial site
- •2. The subjects can be scheduled for sentinel node biopsy (SNB) without ICG
- •3. Subjects with a sub side oral or oropharyngeal cancer i.e., cancer re occurrence is in a new area
- •4. Location of tumor suitable for imaging i.e., isolated/detached cancer where the subject can open the mouth for the tumor to be accessible
- •5. Subjects aged 18 years or older
- •6. Capable of understanding and giving written informed consent
- •7. Subject must not previously have received the trial drug (FG001)
- •8. Male subjects must commit to use barrier contraception (e.g., condom) during the trial and for 30 days after the end-of-trial visit and avoid sperm donation during this period
- •9. Women of childbearing potential must agree to use an adequate method of contraception during the trial and for 30 days after the end-of-trial visit. Adequate methods of contraception include intrauterine device or hormonal contraception (oral contraceptive pill, depot injections or implant, transdermal depot patch or vaginal ring). To be considered sterilised or infertile, females must have undergone surgical sterilisation (bilateral tubectomy, hysterectomy or bilateral ovariectomy) or be post-menopausal (defined as at least 12 months amenorrhoea; may be confirmed with follicle-stimulating hormone [FSH] test if there is doubt)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 17
排除标准
- •1. Scheduled sentinel node biopsy (SNB) with ICG-based optical tracer
- •2. Previous surgery, chemotherapy or radiotherapy to the oral cavity
- •3. Any known allergy or hypersensitivity to indocyanine green (ICG) or any other component of the drug product
- •4. Female subjects who are pregnant or breast-feeding (pregnancy test positive prior to inclusion)
- •5. Overall performance status or co-morbidity deeming the subject unfitted for participation in the trial as judged by the Investigator
- •6. Pre-existing hepatic and/or renal insufficiency
- •o Estimated GFR (eGFR) < 45 ml/min/1.73m2
- •o INR > 1.7
- •If a subject is being treated with anticoagulants and the INR is borderline (1.8) and the PI judges the subject to be eligible with no safety concerns AND the CMO at FluoGuide agrees, such subject may be deemed eligible for the trial. This must be clearly documented in the medical journal and at FluoGuide.
研究者
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