Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000402246
Ethics application status
Approved
Date submitted
29/03/2009
Date registered
2/06/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Correlation of preoperative combined positron emission tomography/computed tomograpy with surgical and histopathological findings for patients with endometrial cancer
Scientific title
Correlation of preoperative combined positron emission tomography/computed tomograpy with surgical and histopathological findings for patients with endometrial cancer
Secondary ID [1] 834 0
09038A Research Project Application No for Research Directorate Southern Health
Universal Trial Number (UTN)
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometrial (Uterine) cancer 4509 0
Condition category
Condition code
Cancer 4788 4788 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
preoperative combined positron emission tomography/computed tomograpy (PET/CT)
This involves the patient undergoing a combined imaging technique: the patient is required to lie on their back in a PET/CT machine for approximately 40-60 minutes following administration of intravenous contrast agent as is normally given with routine CT, and injection of radioactive marker fluoro-2-deoxyglucose (FDG)
Intervention code [1] 4258 0
Diagnosis / Prognosis
Comparator / control treatment
All patients will undergo PET/CT, and all will undergo surgical and histological staging as part of their management for Endometrial cancer. Surgical and histological findings are the comparator
Control group
Active

Outcomes
Primary outcome [1] 5685 0
Evidence of fluoro-2-deoxyglucose (FDG) uptake corresponding with presence of primary lesion
Will Use regression techniques to examine the influence of prognostic variables on test characteristics. For each of the tests calculate sensitivity, specificity, positive and negative values and compare the performance of the two tests with risk ratios and 95% confidence intervals
Timepoint [1] 5685 0
Following surgery and review of histopathology: Baseline only
Primary outcome [2] 5686 0
Evidence of FDG uptake corresponding with presence of distant disease including lymphatic spread
Will Use regression techniques to examine the influence of prognostic variables on test characteristics. For each of the tests calculate sensitivity, specificity, positive and negative values and compare the performance of the two tests with risk ratios and 95% confidence intervals
Timepoint [2] 5686 0
Following surgery and review of histopathology: Baseline only
Secondary outcome [1] 241537 0
Histopathological finding with tumour grade
Will Use regression techniques to examine the influence of prognostic variables on test characteristics. For each of the tests calculate sensitivity, specificity, positive and negative values and compare the performance of the two tests with risk ratios and 95% confidence intervals
Timepoint [1] 241537 0
Baseline only
Secondary outcome [2] 241584 0
Strength of FDG uptake as objectively measured by standard uptake values
Will Use regression techniques to examine the influence of prognostic variables on test characteristics. For each of the tests calculate sensitivity, specificity, positive and negative values and compare the performance of the two tests with risk ratios and 95% confidence intervals
Timepoint [2] 241584 0
Baseline only
Secondary outcome [3] 241585 0
Strength of FDG uptake as objectively measures by standard uptake values and its correspondance with cell type
Will Use regression techniques to examine the influence of prognostic variables on test characteristics. For each of the tests calculate sensitivity, specificity, positive and negative values and compare the performance of the two tests with risk ratios and 95% confidence intervals
Timepoint [3] 241585 0
Baseline only
Secondary outcome [4] 241586 0
Clinical impact of PET/CT
Will examine clinical prognostic features and assess these relative to test characteristics.
Will Use regression techniques to examine the influence of prognostic variables on test characteristics. For each of the tests calculate sensitivity, specificity, positive and negative values and compare the performance of the two tests with risk ratios and 95% confidence intervals
Timepoint [4] 241586 0
Baseline only

Eligibility
Key inclusion criteria
All women presenting to Southern Health with diagnosis of endometrial cancer
Minimum age
18 Years
Maximum age
95 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous surgery for endometrial cancer
other cancers
Not for surgical intervention

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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 4695 0
Commercial sector/Industry
Name [1] 4695 0
Medical Imaging Australia
Country [1] 4695 0
Australia
Primary sponsor type
Hospital
Name
Southern Health
Address
Monash Medical Centre: Main Campus 246 Clayton Rd East Bentleigh Vic 3168
Country
Australia
Secondary sponsor category [1] 4242 0
None
Name [1] 4242 0
Address [1] 4242 0
Country [1] 4242 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6732 0
Southern Health Research Directorate
Ethics committee address [1] 6732 0
Level 4 Main Block Monash Medical Centre: Main Campus 246 Clayton Rd Clayton Vic 3168
Ethics committee country [1] 6732 0
Australia
Date submitted for ethics approval [1] 6732 0
05/03/2009
Approval date [1] 6732 0
12/03/2009
Ethics approval number [1] 6732 0
09038A

Summary
Brief summary
Prospective study to be conducted at Monash Medical Centre Moorabbin Melbourne Victoria. The aim is to determine whether Positron Emission Tomography combined with computed tomography (PET/CT) is able to predict the stage and spread of uterine (Endometrial) Cancer when performed preoperatively. A further aim is to determine whether its use is beneficial in guiding further treatment of the patient, With our hypothesis being that PET/CT is useful in ensuring appropriate management of the woman with uterine cancer
Trial website
None
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 29421 0
Address 29421 0
Country 29421 0
Phone 29421 0
Fax 29421 0
Email 29421 0
Contact person for public queries
Name 12668 0
Kym Reid
Address 12668 0
Gynaecology Oncology Department
Monash Moorabbin Campus Centre Rd East Bentleigh Vic 3184
Country 12668 0
Australia
Phone 12668 0
+61 3 99288243
Fax 12668 0
+61 3 99288587
Email 12668 0
kym.m.reid@gmail.com (no professional email)
Contact person for scientific queries
Name 3596 0
Kym Reid
Address 3596 0
Gynaecology Oncology Department
Monash Moorabbin Campus Centre Rd East Bentleigh Vic 3184
Country 3596 0
Australia
Phone 3596 0
+61 3 99288243
Fax 3596 0
+61 3 99288587
Email 3596 0
kym.m.reid@gmail.com (no professional email)

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.