Not Yet RecruitingPhase 2ACTRN12606000048583

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


Sponsor

AGEN Biomedical Ltd

Enrollment

6 participants

Start Date

Feb 13, 2006

Study Type

Interventional

Conditions


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying: ThromboView Phase Ib PE Extension Study. It may be open to adults aged 18 and older. Participation typically involves medical assessments, possible treatment with the study intervention, and follow-up visits to track your health.

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

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 pulmon

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)

Australia

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ACTRN12606000048583