Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000048583
Ethics application status
Approved
Date submitted
27/01/2006
Date registered
1/02/2006
Date last updated
1/02/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
ThromboView Phase Ib PE Extension Study
Scientific title
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
Secondary ID [1] 236 0
AUS-002-I-PE
Universal Trial Number (UTN)
Trial acronym
Not Applicable
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diagnosis of Pulmonary Emboli (PE) 1010 0
Condition category
Condition code
Cardiovascular 1086 1086 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 868 0
Diagnosis / Prognosis
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1451 0
Confirm the safety and tolerability of [99mTc]ThromboView prepared using a two-vial formulation in patients with PE.
Timepoint [1] 1451 0
Safety will be measured from the time of consent to completion of the safety followup period (Day 90).
Secondary outcome [1] 2595 0
1. Further explore optimum parameters for acquisition and processing of [99mTc] ThromboView thoracic SPECT and planar images for detection of PE.
Timepoint [1] 2595 0
Image analysis and independent review will be performed at the completion of recruitment phase of the study.
Secondary outcome [2] 2596 0
2. Explore the pharmacokinetic profile of [99mTc] ThromboView two-vial formulation in subjects with PE.
Timepoint [2] 2596 0
Pharmacokinetic analysis will be performed at the completion of monitoring of the Day 7 followup visit of the last subject enrolled and confirmed evaluable.
Secondary outcome [3] 2597 0
3. Continue to develop preliminary guidelines for the interpretation of thoracic Single Photon Emission Computed Tomography (SPECT) and planar images acquired following injection of [99mTc] ThromboView.
Timepoint [3] 2597 0
This outcome will be measured at the final Study Steering Committee meeting where results of all Image interpretation is performed.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1190 0
Commercial sector/Industry
Name [1] 1190 0
AGEN Biomedical Ltd
Country [1] 1190 0
Primary sponsor type
Commercial sector/Industry
Name
AGEN Biomedical Ltd
Address
Country
Australia
Secondary sponsor category [1] 1048 0
None
Name [1] 1048 0
Nil
Address [1] 1048 0
Country [1] 1048 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2505 0
Westmead Hospital
Ethics committee address [1] 2505 0
Ethics committee country [1] 2505 0
Australia
Date submitted for ethics approval [1] 2505 0
Approval date [1] 2505 0
Ethics approval number [1] 2505 0
Ethics committee name [2] 2506 0
St. George Hospital
Ethics committee address [2] 2506 0
Ethics committee country [2] 2506 0
Australia
Date submitted for ethics approval [2] 2506 0
Approval date [2] 2506 0
Ethics approval number [2] 2506 0
Ethics committee name [3] 2507 0
Flinders Medical Centre
Ethics committee address [3] 2507 0
Ethics committee country [3] 2507 0
Australia
Date submitted for ethics approval [3] 2507 0
Approval date [3] 2507 0
Ethics approval number [3] 2507 0
Ethics committee name [4] 2508 0
St. Vincent's Hospital (Melbourne)
Ethics committee address [4] 2508 0
Ethics committee country [4] 2508 0
Australia
Date submitted for ethics approval [4] 2508 0
Approval date [4] 2508 0
Ethics approval number [4] 2508 0
Ethics committee name [5] 2509 0
The Queen Elizabeth Hospital
Ethics committee address [5] 2509 0
Ethics committee country [5] 2509 0
Australia
Date submitted for ethics approval [5] 2509 0
Approval date [5] 2509 0
Ethics approval number [5] 2509 0
Ethics committee name [6] 2510 0
Royal Perth Hospital
Ethics committee address [6] 2510 0
Ethics committee country [6] 2510 0
Australia
Date submitted for ethics approval [6] 2510 0
Approval date [6] 2510 0
Ethics approval number [6] 2510 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35761 0
Address 35761 0
Country 35761 0
Phone 35761 0
Fax 35761 0
Email 35761 0
Contact person for public queries
Name 10057 0
Dr David Macfarlane
Address 10057 0
Department of Nuclear Medicine
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country 10057 0
Australia
Phone 10057 0
+61 7 36367271
Fax 10057 0
+61 7 36368481
Email 10057 0
david_macfarlane@health.qld.gov.au
Contact person for scientific queries
Name 985 0
Dr David Macfarlane
Address 985 0
Department of Nuclear Medicine
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country 985 0
Australia
Phone 985 0
+61 7 36367271
Fax 985 0
+61 7 36368481
Email 985 0
david_macfarlane@health.qld.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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