EUCTR2021-004389-37-DK进行中（未招募）1 期
An open-label, non-randomized, single dose, exploratory Phase II trial of FG001 (an imaging agent) for localization of biopsy-proven primary non-small cell lung cancer (NSCLC)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients are eligible to enter into this trial only if they meet all of the following criteria:
- •1. Biopsy-verified NSCLC (adenocarcinoma or squamous-cell carcinoma) and scheduled for surgery (VATS). Note that biopsy-verified NSCLC refers to the biopsy upon which the patient was diagnosed with NSCLC
- •2. Peripheral location of the tumor (based on CT/MRI/PET scan no later than 8 weeks old from screening date or a scan must be taken at baseline visit)
- •3. Tumor size = 1.5 cm
- •4. No suspicion of metastatic disease
- •5. Patients aged 18 years or older
- •6. Capable of understanding and giving written informed consent
- •7. Patient must not previously have received the trial drug (FG001)
- •8. Male patients 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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •Patients are eligible to enter into this trial only if they do NOT meet any of the following criteria:
- •1. Any known allergy or hypersensitivity to indocyanine green (ICG) or any other component of the drug product
- •2. Female patients who are pregnant or breast-feeding (pregnancy test positive prior to inclusion)
- •3. Overall performance status or co-morbidity deeming the patient unfitted for participation in the trial as judged by the Investigator
- •4. Pre-existing hepatic and/or renal insufficiency
- •- INR > 1,7
- •- Estimated GFR (eGFR) >45 ml/min/1,73m2
- •5. Unwilling or unable to follow the protocol requirements
研究者
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