ThromboView Phase Ib PE Extension Study
Extension to Multi Centre, Phase Ib Safety Study of anti-fibrin humanised monoclonal antibody (DI-DD3B6/22-80B3) Fab’ Protein Fragment (ThromboView®) conjugated with Technetium-99m in the Detection of Pulmonary Emboli
AGEN Biomedical Ltd
6 participants
Feb 13, 2006
Interventional
Conditions
Eligibility
Plain Language Summary
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Interventions
Extension to Phase Ib, multi centre, prospective image acquisition trial of [99mTc]ThromboView, at a dose of 0.5 mg labelled with 685-785 MBq 99mTc, in subjects with a diagnosis of at least one pulmonary embolus at a segmental or more proximal pulmonary artery level by CTPA. Eligible and consenting study subjects will receive a single dose of [99mTc]ThromboView prepared using a two-vial formulation and administered by intravenous injection within 72 hours of having undergone a CTPA scan to determine eligibility. Nuclear Medicine imaging scans (both SPECT and Planar) will be performed at 15 minutes, 2 & 4 hours post injection. 24 hour blood and urine sampling performed to assess Radiopharmacokinetc profile. Subjects return for safety assessments at Days 7, 30 and 90 post-injection.
Locations(1)
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ACTRN12606000048583