NL-OMON48830已完成不适用
A phase I study assessing the safety and performance of VB5-845D-800CW, an anti-Epcam fluorescent agent, for the intraoperative detection of gastrointestinal cancer - Intra-operative imaging of gastrointestinal cancer using VB5-845D-800CW
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Part A (healthy volunteers)
- •A maximum of sixteen (16) healthy volunteers will take part in this study.
- •Inclusion criteria
- •1) The subject is 18-65 years old at screening.
- •2) The subject is able and willing to comply with study procedures, and signed
- •and dated informed consent is obtained before any study-related procedure is
- •3) Female subjects need to be surgically sterile, post-menopausal or
- •pre-menopausal with a negative urine pregnancy test at screening and just
- •before administration of VB5-845D-800CW. Pre-menopausal female subjects have to
- •agree to use an effective method of contraception for 90 days after
- •administration. Male subjects have to agree to use an effective method of
- •contraception for 90 days after administration.
- •4) The subject has a normal or clinically acceptable medical history, physical
- •examination, and vital signs findings at screening.
- •5) The subject*s screening ECG and clinical laboratory test results are within
- •normal limits, or if any are outside of normal limits they are considered to be
- •clinically insignificant.
- •6) The subject has negative screening test results for hepatitis B, hepatitis
- •C, and human immunodeficiency virus.
- •7) The subject has negative test results for drug and alcohol screening.
- •8) Absence of any psychological, familial, sociological or geographical
- •condition potentially hampering compliance with the study protocol and
- •follow-up schedule; those conditions should be discussed with the patient
- •before registration in the trial.
- •Part B (patients)
- •The study will be performed in maximum 18 patients. At each dose level 6
- •patients will be studied. An additional 6 patients will be included in the
- •cohort with the most optimum dose level.
- •Inclusion criteria
- •1) Patients > 18 years;
- •2) Patients capable and willing to give informed consent before study specific
- •procedures;
- •3) Patients with suspected esophageal/gastric- or colorectal cancer, planned
- •for an open or laparoscopic esophageal/gastric resection or colorectal
- •resection respectively or transanal colorectal resection;
- •4) Normal and clinically acceptable medical history, medical physical
- •examination and vital signs at screening;
- •5) The subject*s clinical laboratory tests are within normal limits, or if any
- •are outside of normal limits they are considered to be clinically insignificant;
- •6) Absence of any physiological, familial, sociological or geographical
- •condition potentially hampering compliance with the study protocol and
- •follow-up schedule; those conditions should be discussed with the patient
- •before registration in the trial.
排除标准
- •Part A (healthy volunteers)
- •A maximum of sixteen (16) healthy volunteers will take part in this study. ,
- •Exclusion criteria
- •1) Female subjects that are lactating or pregnant.
- •2) Unacceptable known diagnoses or diseases at baseline, e.g., known
- •cardiovascular or pulmonary disease, renal or liver dysfunction, ECG or
- •laboratory abnormalities, etc.
- •3) Use of prescription drugs, with the exception of contraceptive drugs.
- •4) Participation in a clinical trial within 90 days of screening or more than 4
- •times in the previous year.
- •5) History of significant allergies or anaphylactic reactions.
- •Part B (patients)
- •The study will be performed in maximum 18 patients. At each dose level 6
- •patients will be studied. An additional 6 patients will be included in the
- •cohort with the most optimum dose level.
- •Exclusion criteria
- •Patients will be excluded if any of the criteria below apply:
- •1) History of a clinically significant allergy or anaphylactic reactions;
- •2) Patients pregnant or breastfeeding;
- •3) Any condition that the investigator considers to be potentially jeopardizing
- •the patients well-being or the study objectives
研究者
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