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
14 participants
Jan 6, 2005
Interventional
Conditions
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Subjects who have undergone a CTPA within the last 72 hours for the evaluation of PE that demonstrates at least one intraluminal filling defect in a segmental or more proximal pulmonary artery will be approached for the study. Following consent and screening procedures (Medical History confirmed, Blood test, ECG, Physical Exam), subjects will be injected with [99mTc] ThromboView and undergo nuclear medicine imaging scans both SPECT and planar acquisitions at 15 minutes, 2 and 4 hours post injection. 24 hour blood and urine sampling will be performed to assess the radiopharmacokinetic profile in the subject population. Subjects will return for safety assessment at Day 7, 30 and 90. Blood sampling for HAHA analysis will be performed at Baseline, Day 7, 30 and 90.
Locations(1)
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ACTRN12605000010695