Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000934044
Ethics application status
Approved
Date submitted
29/10/2010
Date registered
3/11/2010
Date last updated
9/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Optical coherence tomography in the assessment of breast cancer
Scientific title
In patients with breast cancer, is optical coherence tomography as accurate as histology in identifying cancerous tissue.
Secondary ID [1] 252987 0
Nil
Universal Trial Number (UTN)
U1111-1117-6013
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 258525 0
Condition category
Condition code
Cancer 258684 258684 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Optical coherence tomography (OCT) is an imaging technique which acquires high resolution images of tissue. It is analogous to ultrasound, but uses reflections of near infrared light waves instead of sound waves. Different tissue types reflect different amounts of light. In this study, we scan ex vivo tissue samples, and compare the OCT images against histology to assess whether cancerous tissue can be distinguished from healthy tissue. Scans are performed on fresh (unfixed) ex vivo human breast tissue samples immediately after excision from the patient. No additional tissue is excised for this study – scans are performed on tissue that is excised as part of normal surgery. Image acquisition takes approximately 2-10 minutes. Tissue then undergoes histological assessment and the results are correlated against the OCT image.
Intervention code [1] 257509 0
Diagnosis / Prognosis
Comparator / control treatment
After scanning with optical coherence tomography (OCT), the ex vivo tissue samples are fixed, embedded in paraffin, and hematoxylin and eosin (H&E) stained histological sections are prepared. Areas of cancerous and healthy tissue in the histological sections are then correlated against the optical coherence tomography images. Both OCT imaging and H&E stained histological analysis are performed on samples after excision from the patient, and so do not require any additional effort from the patient. Histological analysis is only performed once on each ex vivo sample. Histological processing typically requires 2-4 days.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259541 0
Identification of cancerous breast tissue. The optical coherence tomography (OCT) image is a three dimension data set. Visualization software is used to extract an oblique plane which closely matches the two dimensional histological section. Different tissue types in the OCT image and histological section are then correlated, and areas of cancerous tissue are identified. The correlation is successful is cancerous tissue identified in the histological section is also identified in the OCT image.
Timepoint [1] 259541 0
At completion of histological processing and sectioning of tissue.
Secondary outcome [1] 266155 0
Identification of cancerous breast tissue. This secondary outcome is assessed in the same manner as for the Primary outcome above. However, the initial assessment of the presence of cancerous tissue in the optical coherence tomography (OCT) image is performed immediately after OCT image acquisition, and prior to completion of histological analysis.
Timepoint [1] 266155 0
Immediately after acquisition of imaging scan with optical coherence tomography.

Eligibility
Key inclusion criteria
Breast cancer patient undergoing surgery.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

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
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 257959 0
Government body
Name [1] 257959 0
Australian Research Council
Country [1] 257959 0
Australia
Funding source category [2] 257960 0
Charities/Societies/Foundations
Name [2] 257960 0
National Breast Cancer Foundation
Country [2] 257960 0
Australia
Funding source category [3] 257961 0
Charities/Societies/Foundations
Name [3] 257961 0
Cancer Council WA
Country [3] 257961 0
Australia
Primary sponsor type
Individual
Name
Dr Robert McLaughlin
Address
M018, School of Electrical, Electronic and Computer Engineering, University of Western Australia, 35 Stirling Hwy, Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 257160 0
Individual
Name [1] 257160 0
Prof. Christobel Saunders
Address [1] 257160 0
M507, School of Surgery, QEII Medical Centre, M Block 2nd Floor, Nedlands WA 6907
Country [1] 257160 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259971 0
Sir Charles Gairdner Hospital Human Research Ethics Committee
Ethics committee address [1] 259971 0
Sir Charles Gairdner Hospital, Hospital Ave, Nedlands, WA 6009
Ethics committee country [1] 259971 0
Australia
Date submitted for ethics approval [1] 259971 0
Approval date [1] 259971 0
10/01/2008
Ethics approval number [1] 259971 0
2007-152

Summary
Brief summary
This study looks at whether a new imaging technique, referred to as optical coherence tomography (OCT), is as accurate as histology (examining cells under a microscope) in identifying cancerous tissue in people with breast cancer.

Who is it for?
You can join this study if you are a woman or man with breast cancer and are about to undergo surgery.

Trial details
In this preliminary study, OCT images of tissue samples removed during surgery will be compared to standard histology, to see whether OCT can reliably distinguish cancerous and healthy tissue.

OCT is an imaging technique which acquires high resolution images of tissue. It is similar to ultrasound, but uses reflections of near infrared light waves instead of sound waves. OCT could potentially be used on tissue before it is cut out of the patient, which would avoid the unnecessary removal of healthy tissue during breast cancer surgery. Results from this trial will form the basis for future trials which will be performed on human tissue prior to removal of the tissue from the patient.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31849 0
Address 31849 0
Country 31849 0
Phone 31849 0
Fax 31849 0
Email 31849 0
Contact person for public queries
Name 15096 0
Dr Robert McLaughlin
Address 15096 0
M018, School of Electrical, Electronic and Computer Engineering, University of Western Australia, 35 Stirling Hwy, Crawley WA 6009
Country 15096 0
Australia
Phone 15096 0
+61 8 64883105
Fax 15096 0
+61 8 64881319
Email 15096 0
[email protected]
Contact person for scientific queries
Name 6024 0
Robert McLaughlin School of Electrical, Electronic and Computer Engineering 0400186544
Address 6024 0
M018, School of Electrical, Electronic and Computer Engineering, University of Western Australia, 35 Stirling Hwy, Crawley WA 6009
Country 6024 0
Australia
Phone 6024 0
+61 8 64883105
Fax 6024 0
+61 8 64881319
Email 6024 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.