Clinical Trial Details
Braintumor Website

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NCT02097875 : Safety Study of a Fluorescent Marker to Visualize Cancer Cells
PhasePhase 1
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- 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
advanced disease.

- 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.

Exclusion Criteria:

- 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).
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