An Exploratory, Open Label, Multi-Center, Non-Randomized Study of [F-18]VM4-037
Status:
Completed
Trial end date:
2010-03-01
Target enrollment:
Participant gender:
Summary
Phase: Exploratory Study
Objectives: To collect drug bio-distribution data, begin collection of baseline and
tumor/background imaging data, acquire experience to improve study design and the conduct of
future studies
Design: Exploratory, open label, nonrandomized, multi-center study
Duration: Three visits - one screening, one imaging, and one follow-up visit at 24 hours
post-dose
Procedures: Informed consent, collection of demographic information and medical history,
physical examinations, vital signs, 12-lead ECGs, routine blood tests to assess major organ
functions, complete blood counts and clinical chemistries for safety, blood sample for CA-IX
assay, pre-dose and post-dose blood samples for metabolite analysis, dosing with
[F-18]VM4-037, PET imaging scan, dosimetry estimation (normals), urine collections (normals),
tumor immunohistochemistry with CA-IX biomarker, follow up to imaging to collect adverse
events
Subjects: Approximately sixteen (16) adult subjects including four (4) healthy volunteers and
twelve (12) cancer subjects who have confirmed or highly suspected diagnosis of head & neck,
lung, large solitary hepatic and renal cell cancer, as defined by protocol criteria