Safety Assessment
stroke, headache, Cancer
ADVERSE EVENT, ADVERSE EVENTS, BRAIN METASTASES, STROKE, ADVERSE EVENT, CANCER
Safety was assessed in 7 subjects. Eight adverse events were documented (Supplemental Table 2). One adverse event (Common Terminology Criteria for Adverse Events grade 1; National Cancer Institute) was possibly related to the radiotracer. It was a transient increase in headache, occurring in a patient with known brain metastases that progressed at follow-up. In 1 patient, a severe adverse event was recorded (stroke, Common Terminology Criteria for Adverse Events grade 3) 56 d after injection and was considered unrelated. Clinical laboratory testing of blood, taken before and 360 min after injection, showed no significant changes that could be related. No increase in blood cytokine levels was observed after injection (Supplemental Fig. 1).