None listed
Conditions
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 deter
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.
Sponsors
AGEN Biomedical Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Ability to provide signed informed consent.2.Onset of most recent episode of symptoms of PE within 7 days prior to enrolment.3.Positive diagnosis of PE (as above) by CTPA performed in the last 72 hours. 4.Women of child-bearing potential must have a negative serum pregnancy test result at time of enrolment. Both male and female participants must agree to use effective contraception for the first 30 days of their involvement in the study.
Exclusion criteria
1. Subject is unwilling/unable to consent.2.Prior parenteral exposure to murine, chimeric, or humanized antibodies. 3.Inability to undergo the required imaging protocol, due to either subject factors or equipment limitations.4.Therapeutic anticoagulation for more than 72 hours prior to the planned time of ThromboView administration.5.Thrombolytic therapy during the current presentation.6.Prior imaging studies or treatment with radiolabelled isotopes (within relative time decay windows). 7.Prior non-imaging, non-therapeutic study with 131-I within last 2 weeks.8.Life expectancy less than 90 days.9.Previous participation in the present study or in any previous ThromboView studies. Current enrolment in a clinical trial for another investigational agent.10.Geographic inaccessibility that precludes follow-up visits.11.Renal dysfunction: serum creatinine > 1.5 x upper limit of normal range.12.Hepatic dysfunction: serum transaminases > 3 x upper limit of normal range.13. Current pregnancy or lactation, or conception intended within 3 months of enrolment.14.Subjects with previously documented PE.15.Any primary or metastatic malignancies involving the lungs or pleura.16.Diffuse active inflammatory or infectious pulmonary conditions (involving >2 segments of a lung).17.Any other medical condition which in the opinion of the investigator would prevent successful completion of the trial.18.Likely inability to gain IV access as per protocol.
Outcome results
None listed