RecruitingPhase 2ACTRN12605000010695

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


Sponsor

AGEN Biomedical Ltd

Enrollment

14 participants

Start Date

Jan 6, 2005

Study Type

Interventional

Conditions


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests a special imaging agent called ThromboView that may help doctors detect blood clots in the lungs (called pulmonary emboli or PE) more accurately. ThromboView is attached to a small amount of a radioactive substance and injected into the body so that doctors can use a scanner to find where blood clots are located. The study is checking how safe this new imaging method is. You may be eligible if: - You are 18 years of age or older - You have recently been diagnosed with a blood clot in the lungs (pulmonary embolism) confirmed by a CT scan in the last 72 hours - Your symptoms started within the last 7 days - If you are a woman who could become pregnant, you have had a negative pregnancy test - You agree to use contraception for the first 30 days of the study You may NOT be eligible if: - You have had a previous blood clot in the lungs - You have been on blood thinning medication for more than 72 hours - You have received clot-dissolving (thrombolytic) therapy - You have kidney or liver problems - You have lung or chest cancer - You are currently pregnant or breastfeeding - You have had previous exposure to mouse- or human-derived antibodies as a treatment - Your life expectancy is less than 90 days Talk to your doctor about whether this trial might be right for you.

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

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)

Australia

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ACTRN12605000010695