Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000300077
Ethics application status
Approved
Date submitted
9/02/2010
Date registered
15/04/2010
Date last updated
15/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Accuracy of a Positron Emission Tomography (PET) and Beta Probe in the Staging of Ductal Carcinoma In Situ & Invasive Ductal Cancer of the Breast.
Scientific title
Accuracy of a Positron Emission Tomography (PET) and Beta Probe in the Staging of Ductal Carcinoma In Situ & Invasive Ductal Cancer of the Breast.
Secondary ID [1] 1599 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 256791 0
Condition category
Condition code
Cancer 256938 256938 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This multidisciplinary one year study will consist of a cohort of 60 patients who have ductal carcinoma in situ (DCIS) or invasive breast cancer, as confirmed by biopsy. Thirty minutes prior to theatre, the patient is injected with 150MBq of f18flurodeoxyglucose (FDG) through a cannula placed in the contra-lateral arm to the breast of interest. Once the specimen has been surgically removed and orientated, the Surgeon will use the beta probe to record counts within the surgical cavity, recording the same orientated surfaces as for the excised tissue. The excised tissue will be orientated and the counts recorded for each of the six surfaces (superior, inferior, medial, lateral, superficial, deep) using the beta probe. The gamma probe will then be used over the excised tissue to verify the sample contains FDG positive tissue. In this initial study there would be no action taken on these findings.
Intervention code [1] 255996 0
Not applicable
Comparator / control treatment
NA
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257817 0
Accuracy of the PET probe. Counts per second in areas where the probe has detected FDG will be recorded on the data collection sheet. This will be compared to the histology results, and in particular the clearance of the surgical margins and where there was not clearance, distance between the DCIS of invasive tissue and the margin/s.
Timepoint [1] 257817 0
Review all data after one year worth of recruitment
Secondary outcome [1] 263235 0
Confirm probe protocol. A good sensitivity and specificity based on the primary outcome confirms the protocol (injection dose and timing) is correct.
Timepoint [1] 263235 0
Review all data after one year worth of recruitment

Eligibility
Key inclusion criteria
1. Patient with newly diagnosed DCIS or invasive carcinoma of the breast;
2. Planned to undergo surgical wide local excision;
3. Able to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Planned mastectomy or neoadjuvant therapy;
2. Uncontrolled diabetes mellitus;
3. Pregnant at the time of surgery;
4. Unable to provide informed consent.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256501 0
Government body
Name [1] 256501 0
Cancer Australia
Country [1] 256501 0
Australia
Funding source category [2] 256502 0
Charities/Societies/Foundations
Name [2] 256502 0
National Breast Cancer Foundation
Country [2] 256502 0
Australia
Funding source category [3] 256503 0
Charities/Societies/Foundations
Name [3] 256503 0
Cancer Council of WA
Country [3] 256503 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U1987
Perth WA 6845
Country
Australia
Secondary sponsor category [1] 255812 0
None
Name [1] 255812 0
Address [1] 255812 0
Country [1] 255812 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258547 0
Mount Ethics Committee
Ethics committee address [1] 258547 0
Mount Hospital
140 Mounts Bay Road
Perth WA 6000
Ethics committee country [1] 258547 0
Australia
Date submitted for ethics approval [1] 258547 0
08/05/2008
Approval date [1] 258547 0
14/10/2008
Ethics approval number [1] 258547 0
EC28.1
Ethics committee name [2] 258549 0
Curtin University Human Research Ethics Committee
Ethics committee address [2] 258549 0
Curtin University of Technology
GPO Box U1987
Perth WA 6845
Ethics committee country [2] 258549 0
Australia
Date submitted for ethics approval [2] 258549 0
Approval date [2] 258549 0
08/08/2006
Ethics approval number [2] 258549 0
HR 58/2006

Summary
Brief summary
This study is examining if the use of a PET probe during surgery for DCIS or breast cancer can accurately determine if all of the cancer cells have been removed. Currently 20% of patients require a second operation due to potential remaining cancer cells in the breast. Identification of these cells at the time of the first operation may reduce the number of women requiring second
operations. This will have an impact on the patient (time & distress) and the health care system.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30825 0
Address 30825 0
Country 30825 0
Phone 30825 0
Fax 30825 0
Email 30825 0
Contact person for public queries
Name 14072 0
Kerryn Butler-Henderson
Address 14072 0
School of Public Health
Curtin University
GPO Box U1987
Perth WA 6845
Country 14072 0
Australia
Phone 14072 0
+618 9266 7531
Fax 14072 0
Email 14072 0
[email protected]
Contact person for scientific queries
Name 5000 0
Kerryn Butler-Henderson
Address 5000 0
School of Public Health
Curtin University
GPO Box U1987
Perth WA 6845
Country 5000 0
Australia
Phone 5000 0
+618 9266 7531
Fax 5000 0
Email 5000 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

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