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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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Address [1] 258480 0
Department of Research
Sir Charles Gairdner Hospital
Hospital Ave
NEDLANDS PERTH
Western Australia
6009
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
Sir Charles Gairdner Hospital
Hospital Avenue
NEDLANDS PERTH
Western Australia 6009
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
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.
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
Ros.Francis@health.wa.gov.au
Contact person for public queries
Name 15448 0
Ms 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
Elaine.Campbell@health.wa.gov.au
Contact person for scientific queries
Name 6376 0
Dr 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
Tatiana.Segard@health.wa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary