Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000010695
Ethics application status
Approved
Date submitted
12/07/2005
Date registered
15/07/2005
Date last updated
15/07/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
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
Scientific title
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] 86 0
AUS-001-I-PE
Universal Trial Number (UTN)
Trial acronym
Not Applicable
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diagnosis of Pumonary Emboli (PE) 72 0
Condition category
Condition code
Cardiovascular 85 85 0 0
Clotting disorders
Respiratory 86 86 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 11 0
Diagnosis / Prognosis
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 116 0
Confirm the safety and tolerability of ThromboView in patients with Pulmonary Embolism.
Timepoint [1] 116 0
After single diagnostic dose, subjects are followed up for safety at Days 7, 30 and 90.
Secondary outcome [1] 270 0
1. Explore the optimum parameters for acquisition and processing of [99mTc] ThromboView thoracic SPECT and planar images for detection of PE.
Timepoint [1] 270 0
Secondary outcome [2] 271 0
2.Explore the pharmacokinetic profile for [99mTc] ThromboView in subjects with Pulmonary Embolism.
Timepoint [2] 271 0
Secondary outcome [3] 272 0
3. Develop preliminary guidelines for the interpretation of thoracic SPECT and planar images acquired following injection of [99mTc] ThromboView.
Timepoint [3] 272 0

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

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
Recruiting
Date of first participant enrolment
Anticipated
6/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 123 0
Commercial sector/Industry
Name [1] 123 0
AGEN Biomedical Ltd
Country [1] 123 0
Primary sponsor type
Commercial sector/Industry
Name
AGEN Biomedical Ltd
Address
Country
Australia
Secondary sponsor category [1] 89 0
None
Name [1] 89 0
Nil
Address [1] 89 0
Country [1] 89 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 872 0
Westmead Hospital
Ethics committee address [1] 872 0
Ethics committee country [1] 872 0
Australia
Date submitted for ethics approval [1] 872 0
Approval date [1] 872 0
Ethics approval number [1] 872 0
Ethics committee name [2] 873 0
Royal Melbourne Hospital
Ethics committee address [2] 873 0
Ethics committee country [2] 873 0
Australia
Date submitted for ethics approval [2] 873 0
Approval date [2] 873 0
Ethics approval number [2] 873 0
Ethics committee name [3] 874 0
St. George Hospital
Ethics committee address [3] 874 0
Ethics committee country [3] 874 0
Australia
Date submitted for ethics approval [3] 874 0
Approval date [3] 874 0
Ethics approval number [3] 874 0
Ethics committee name [4] 875 0
Flinders Medical Centre
Ethics committee address [4] 875 0
Ethics committee country [4] 875 0
Australia
Date submitted for ethics approval [4] 875 0
Approval date [4] 875 0
Ethics approval number [4] 875 0
Ethics committee name [5] 876 0
Royal North Shore Hospital
Ethics committee address [5] 876 0
Ethics committee country [5] 876 0
Australia
Date submitted for ethics approval [5] 876 0
Approval date [5] 876 0
Ethics approval number [5] 876 0
Ethics committee name [6] 877 0
St. Vincent's Hospital
Ethics committee address [6] 877 0
Ethics committee country [6] 877 0
Australia
Date submitted for ethics approval [6] 877 0
Approval date [6] 877 0
Ethics approval number [6] 877 0
Ethics committee name [7] 878 0
The Queen Elizabeth Hospital
Ethics committee address [7] 878 0
Ethics committee country [7] 878 0
Australia
Date submitted for ethics approval [7] 878 0
Approval date [7] 878 0
Ethics approval number [7] 878 0

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

Contacts
Principal investigator
Name 35943 0
Address 35943 0
Country 35943 0
Phone 35943 0
Fax 35943 0
Email 35943 0
Contact person for public queries
Name 9200 0
Dr David Macfarlane
Address 9200 0
Department of Nuclear Medicine
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country 9200 0
Australia
Phone 9200 0
+61 7 36367271
Fax 9200 0
+61 7 36368481
Email 9200 0
david_macfarlane@health.qld.gov.au
Contact person for scientific queries
Name 128 0
Dr David Macfarlane
Address 128 0
Department of Nuclear Medicine
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country 128 0
Australia
Phone 128 0
+61 7 36367271
Fax 128 0
+61 7 36368481
Email 128 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
No additional documents have been identified.