None listed
Conditions
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 injec
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.
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
Ability to sign informed consent; Onset of most recent episode of symptoms of PE occurring within 7 days of enrolment; Positive diagnosis of PE by CTPA performed in last 72 hours; Women of child-bearing potential to have negative serum pregnancy test at time of enrolment. Both male and female participants agree to use effective contraception for first thirty (30) days of study participation.
Exclusion criteria
Previously documented PE; Unable to undergo required imaging protocol; Prior exposure to murine/ chimeric/ humanized antibodies; Therapeutic anticoagulation for more than 72 hours prior to ThromboView administration; Thrombolytic therapy during current presentation; Renal dysfunction (serum creatinine >1.5 x ULN), renal transplant; Hepatic Dysfunction (serum transaminases > 3 x ULN); Primary or metastatic malignancies lungs/ pleura; Diffuse active inflammatory/ infectious pulmonary conditions involving > 2 lung segments; Life expectancy < 90 days; Geographic inaccessibility precluding follow up visits; Prior nuclear medicine imaging studies with radiolabelled isotopes (within relative time decay windows); Current pregnancy or lactation or conception intended within 3 months of enrolment and likely inability to gain IV Access.
Outcome results
None listed