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Trial registered on ANZCTR


Registration number
ACTRN12611000266965
Ethics application status
Approved
Date submitted
10/03/2011
Date registered
11/03/2011
Date last updated
12/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Developing effective imaging methods to assess chemotherapy response in Malignant Pleural Mesothelioma
Scientific title
Apoptosis detection using Technetium 99m labelled Annexin V SPECT/CT imaging to determine chemotherapy response in patients with Malignant Pleural Mesothelioma following initiation of chemotherapy treatment.
Secondary ID [1] 253593 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mesothelioma 261149 0
Condition category
Condition code
Cancer 259308 259308 0 0
Lung - Mesothelioma

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients will undergo a Single Photon Emission Computed Tomography/Computed Tomography (SPECT/CT) scan with whole body scintigraphy after administration of a Technicium-labelled Annexin V injection at baseline (2 weeks prior to commencement of chemotherapy) and 48 hours after commencement of chemotherapy. Patients will be injected with an average of 850MBq of 99m Tc-HYNIC-rh-Annexin-V prior to each SPECT/CT scan. Patients will also undergo 18F-Fluorodeoxyglucose (18F-FDG) Positron Emission Tomography/Computed Tomography (PET/CT) scans at baseline (within 2 weeks prior to commencement of chemotherapy) and after the first cycle of chemotherapy (just prior to the second cycle of chemotherapy). Administration of 18F-FDG (200 MBq/m2) will be utilised to assess for response to chemotherapy and patients will be imaged 60 minutes after tracer injection.
Intervention code [1] 264204 0
Not applicable
Comparator / control treatment
Routine Computed Tomography (CT) scans will be performed 2 weeks prior to commencement of chemotherapy and after chemotherapy cycle 1.
Control group
Active

Outcomes
Primary outcome [1] 262111 0
Detection of apoptosis assessed by increased Tc-Annexin activity in tumour using SPECT/CT scan.
Timepoint [1] 262111 0
48 hours post commencement of chemotherapy.
Secondary outcome [1] 273186 0
To assess whether the presence of apoptosis following chemotherapy gives preliminary evidence of prediction of clinical benefit from chemotherapy as measured by objective radiological response on CT imaging, FDG PET/CT imaging, time to disease progression and patient survival.
Timepoint [1] 273186 0
18 months post scans.

Eligibility
Key inclusion criteria
Histologically confirmed malignant Mesothelioma
ECOG performance status 0-2
> 18 years of age
Able to undertake SPECT/CT and PET/CT imaging
Written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Age < 18 years
Medical contraindication to SPECT/CT or PET/CT imaging.
Cognitive impairment considered to impair the ability to give written informed consent in the opinion of the treating clinician.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/04/2011
Actual
17/04/2012
Date of last participant enrolment
Anticipated
Actual
26/02/2013
Date of last data collection
Anticipated
Actual
1/11/2015
Sample size
Target
15
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 258480 0
Hospital
Name [1] 258480 0
Sir Charles Gairdner Hospital Research Advisory Committee
Country [1] 258480 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue
NEDLANDS PERTH
Western Australia
6009
Country
Australia
Secondary sponsor category [1] 263787 0
None
Name [1] 263787 0
Address [1] 263787 0
Country [1] 263787 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260457 0
Sir Charles Gairdner Group Human Research Ethics Committee
Ethics committee address [1] 260457 0
Ethics committee country [1] 260457 0
Australia
Date submitted for ethics approval [1] 260457 0
Approval date [1] 260457 0
23/12/2010
Ethics approval number [1] 260457 0
2010-142

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

Contacts
Principal investigator
Name 32201 0
A/Prof Roslyn Francis
Address 32201 0
Department of Nuclear Medicine/ WA PET Service
Sir Charles Gairdner Hospital
Hospital Ave, Nedlands, WA, 6009
Country 32201 0
Australia
Phone 32201 0
+61 8 6457 3233
Fax 32201 0
Email 32201 0
[email protected]
Contact person for public queries
Name 15448 0
Elaine Campbell
Address 15448 0
WA PET Service
Nuclear Medicine Department
Sir Charles Gairdner Hospital
Hospital Avenue
NEDLANDS, WA 6009
Country 15448 0
Australia
Phone 15448 0
+61 8 9346 2322
Fax 15448 0
+61 8 9346 3610
Email 15448 0
[email protected]
Contact person for scientific queries
Name 6376 0
Tatiana Segard
Address 6376 0
WA PET Service / Nuclear Medicine Department
Sir Charles Gairdner Hospital
Hospital Avenue
NEDLANDS, WA 6009
Country 6376 0
Australia
Phone 6376 0
+61 8 9346 2322
Fax 6376 0
+61 8 9346 3610
Email 6376 0
[email protected]

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.