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|NCT02097875 : Safety Study of a Fluorescent Marker to Visualize Cancer Cells|
|Ages||Min: 18 Years Max: N/A|
- Male or female patients age ? 18 years.
- Non-melanotic skin cancer (e.g. non metastatic basal cell or squamous cell carcinomas
or amelanotic melanoma) ?10 mm longest diameter scheduled for excision, without
- Written Informed Consent.
- Agree to the use of effective contraceptive from Baseline and for 30 days after
treatment if either male or female of child bearing potential.
- Available for and able to comply with study requirements.
- Women who are lactating/breastfeeding
- Women with a positive pregnancy test or who are planning to become pregnant during
the duration of the study.
- Life expectancy <6 months.
- Karnofsky Performance Status of ?70%.
- The following laboratory abnormalities:
- Neutrophil count <1.5 x 109/L
- Platelets <75 x 109/L
- Haemoglobin <10 g/dL (may be determined following transfusion)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2x upper
limit of normal (ULN)
- Total bilirubin >2x upper limit of reference range (unless Gilbert's syndrome or
extrahepatic source as denoted by increased indirect bilirubin fraction)
- International Normalized Ratio (INR) >1.5
- Creatinine >1.5x ULN
- History of hypersensitivity or allergic reactions requiring corticosteroids,
epinephrine and/or hospitalization.
- Uncontrolled asthma or asthma requiring oral corticosteroids.
- Clinically significant chronic inflammatory skin conditions, including psoriasis,
atopic dermatitis and scleroderma, as determined by the investigator.
- Unstable angina, myocardial infarction, known or suspected transient ischemic events
or stroke within 24 weeks of Screening.
- Uncontrolled hypertension.
- QTc (corrected QT interval) prolongation >450 msec.
- Receipt of photosensitising drugs within 30 days of screening.
- Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV) or
hepatitis B virus (HBV).
- Any concurrent condition, including psychological and social situations, which, in
the opinion of the investigator, would impact adversely on the subject or the
interpretation of the study data.
- Known or suspected sensitivity to study product or excipients.
- Prior participation in this clinical trial (has received study product).
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02097875
| Link to official Clinicaltrials.gov listing