Please be advised that due to the high volume of submissions, the ANZCTR is currently experiencing delays in processing submissions from those outside of Australia and New Zealand. As the ANZCTR is funded by Australia and New Zealand, we must prioritise submissions from these countries first. International submissions should allow additional time for registration. Apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
Universal Trial Number (UTN)
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

Study type
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

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.

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

Study design
Purpose of the study
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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257959 0
Government body
Name [1] 257959 0
Australian Research Council
Address [1] 257959 0
Level 2, 11 Lancaster Place, Majura Park ACT 2609
Country [1] 257959 0
Funding source category [2] 257960 0
Name [2] 257960 0
National Breast Cancer Foundation
Address [2] 257960 0
Level 9, 50 Pitt Street, Sydney NSW 2000
Country [2] 257960 0
Funding source category [3] 257961 0
Name [3] 257961 0
Cancer Council WA
Address [3] 257961 0
46 Ventnor Avenue, West Perth WA 6005
Country [3] 257961 0
Primary sponsor type
Dr Robert McLaughlin
M018, School of Electrical, Electronic and Computer Engineering, University of Western Australia, 35 Stirling Hwy, Crawley WA 6009
Secondary sponsor category [1] 257160 0
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

Ethics approval
Ethics application status
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
Date submitted for ethics approval [1] 259971 0
Approval date [1] 259971 0
Ethics approval number [1] 259971 0

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

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
Phone 15096 0
+61 8 64883105
Fax 15096 0
+61 8 64881319
Email 15096 0
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
Phone 6024 0
+61 8 64883105
Fax 6024 0
+61 8 64881319
Email 6024 0

No information has been provided regarding IPD availability
Summary results
No Results