NL-OMON48830
Completed
Not Applicable
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
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 34
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Investigators
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