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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
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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.
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Secondary ID [1]
253593
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nil
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Universal Trial Number (UTN)
nil
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Trial acronym
nil
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mesothelioma
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Condition category
Condition code
Cancer
259308
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0
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Lung - Mesothelioma
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
264204
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Not applicable
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Comparator / control treatment
Routine Computed Tomography (CT) scans will be performed 2 weeks prior to commencement of chemotherapy and after chemotherapy cycle 1.
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Control group
Active
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Outcomes
Primary outcome [1]
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Detection of apoptosis assessed by increased Tc-Annexin activity in tumour using SPECT/CT scan.
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Assessment method [1]
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Timepoint [1]
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48 hours post commencement of chemotherapy.
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Secondary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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18 months post scans.
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data collected is being analysed
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Reason for early stopping/withdrawal
Participant recruitment difficulties
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Date of first participant enrolment
Anticipated
1/04/2011
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Actual
17/04/2012
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Date of last participant enrolment
Anticipated
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Actual
26/02/2013
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Date of last data collection
Anticipated
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Actual
1/11/2015
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Sample size
Target
15
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Accrual to date
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Final
8
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Sir Charles Gairdner Hospital Research Advisory Committee
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Address [1]
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Department of Research
Sir Charles Gairdner Hospital
Hospital Ave
NEDLANDS PERTH
Western Australia
6009
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Sir Charles Gairdner Hospital
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Address
Hospital Avenue
NEDLANDS PERTH
Western Australia
6009
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
263787
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Address [1]
263787
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Country [1]
263787
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
260457
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Sir Charles Gairdner Group Human Research Ethics Committee
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Ethics committee address [1]
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Sir Charles Gairdner Hospital
Hospital Avenue
NEDLANDS PERTH
Western Australia 6009
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
260457
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Approval date [1]
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23/12/2010
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Ethics approval number [1]
260457
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2010-142
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Summary
Brief summary
Mesothelioma is an aggressive tumour with a poor outcome and not all patients respond to current best-practice chemotherapy. Response to chemotherapy is currently assessed by measuring tumour size on regular CT scans. Detecting changes in tumour size for Mesothelioma can be difficult due to the growth pattern of the tumour, it grows as a rind around the lining of the chest. Significant changes in 'size' of Mesothelioma on Computerised Tomography (CT) scans may not occur until 2 - 3 months after commencing chemotherapy. The aim of chemotherapy is to cause the tumour cells to die, this process of cell death is called apoptosis. CT scans are able to detect this apoptosis, from chemotherapy treatments, after approximately 3 months. During the past few years, Annexin V has emerged as an agent that can be used to detect cell death. Attaching a radioactive tracer (Technetium -99m), to Annexin V and using a Single Photon Emission Computerised Tomography-CT (SPECT-CT) camera to detect if cell death is occurring one to two days after chemotherapy has started may predict the effectiveness of chemotherapy earlier. This would result in fewer patients continuing ineffective treatment, individualization of chemotherapy treatments, and more rapid and reliable identification of new drugs which may be effective in this disease.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Roslyn Francis
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Address
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Department of Nuclear Medicine/ WA PET Service
Sir Charles Gairdner Hospital
Hospital Ave, Nedlands, WA, 6009
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Country
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Australia
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Phone
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+61 8 6457 3233
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Elaine Campbell
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Address
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WA PET Service
Nuclear Medicine Department
Sir Charles Gairdner Hospital
Hospital Avenue
NEDLANDS, WA 6009
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Country
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Australia
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Phone
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+61 8 9346 2322
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Fax
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+61 8 9346 3610
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Tatiana Segard
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Address
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WA PET Service / Nuclear Medicine Department
Sir Charles Gairdner Hospital
Hospital Avenue
NEDLANDS, WA 6009
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Country
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Australia
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Phone
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+61 8 9346 2322
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Fax
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+61 8 9346 3610
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Email
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[email protected]
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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.
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