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Trial registered on ANZCTR


Registration number
ACTRN12621000329864
Ethics application status
Approved
Date submitted
15/02/2021
Date registered
23/03/2021
Date last updated
23/03/2021
Date data sharing statement initially provided
23/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does Confocal Laser Endomicroscopy enable identification of positive and negative surgical margin during breast cancer surgery.
Scientific title
Does Confocal Laser Endomicroscopy enable identification of positive and negative surgical margin during breast conservation surgery (wide local excision and cavity shave).
Secondary ID [1] 303457 0
TGA clinical trial notification CT-2020-CTN-03062-1 V1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 320765 0
Condition category
Condition code
Cancer 318594 318594 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Tissue excised during wide local excision with cavity shaves will be stained with acriflavine and then imaged intraoperatively with a handheld confocal endomicroscope, with images being collected and assessed for involved margins for each piece of tissue excised during the procedure. Tissue will then be fixed and processed using standard pathology processes. The ability of confocal endomicroscopy to identify involved margins will be assessed against the results from pathology. The surgeon and pathologists will be blinded to the confocal imaging results, so there will be no deviation from normal standard of care for patients in this study.
The tissue will be excised as per standard of care before imaging.
The confocal endomicroscopy will be done by an Optiscan technician who is trained in the use of the endomicroscope.
This will not add any additional time to the surgical procedure as it is being performed on excised tissue.
Intervention code [1] 319989 0
Not applicable
Comparator / control treatment
Standard pathology will be used as the reference comparator for this study. This involves the standard protocol for tissue cut-up, blocking, sectioning and placing onto glass slides followed by H&E staining and examination of the stained sections by a pathologist.
Control group
Active

Outcomes
Primary outcome [1] 326552 0
Accurate identification of positive cancer margins intraoperatively using a confocal endomicroscope. Accuracy of margin identification to be compared to standard pathology.
Timepoint [1] 326552 0
Intraoperatively - within a few minutes of the tissue being excised.
Primary outcome [2] 326833 0
Accurate identification of negative cancer margins intraoperatively using a confocal endomicroscope. Accuracy of margin identification to be compared to standard pathology.
Timepoint [2] 326833 0
Intraoperatively - within a few minutes of the tissue being excised.
Secondary outcome [1] 391852 0
Nil
Timepoint [1] 391852 0
Nil

Eligibility
Key inclusion criteria
Patients over age 18 years with breast cancer undergoing primary wide local excision with cavity shave (“WLE + CS”)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients undergoing re-excision after prior wide local excision (“WLE”).
Patients without study consent.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/03/2021
Date of last participant enrolment
Anticipated
14/05/2021
Actual
Date of last data collection
Anticipated
31/05/2021
Actual
Sample size
Target
20
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18719 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment hospital [2] 18720 0
Frances Perry House - Parkville
Recruitment hospital [3] 18721 0
Epworth Freemasons (Clarendon Street) - East Melbourne
Recruitment postcode(s) [1] 33162 0
3052 - Parkville
Recruitment postcode(s) [2] 33163 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 307875 0
Other
Name [1] 307875 0
Medical Device Partnering Program
Country [1] 307875 0
Australia
Funding source category [2] 307878 0
Commercial sector/Industry
Name [2] 307878 0
Optiscan Pty Ltd
Country [2] 307878 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Optiscan Pty Ltd
Address
16 Miles St
Mulgrave, Vic 3170
Country
Australia
Secondary sponsor category [1] 308587 0
None
Name [1] 308587 0
None
Address [1] 308587 0
None
Country [1] 308587 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307876 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 307876 0
Office for Research
The Royal Melbourne Hospital
Level 2 South West
300 Grattan St
Parkville Vic 3050
Australia
Ethics committee country [1] 307876 0
Australia
Date submitted for ethics approval [1] 307876 0
29/09/2020
Approval date [1] 307876 0
10/12/2020
Ethics approval number [1] 307876 0
HREC/68536/MH-2020

Summary
Brief summary
The purpose of this study is to determine if an imaging method called confocal endomicroscopy can accurately identify the margins of breast cancer during surgery.

Who is it for?
You may be eligible for this study if you are an adult who has breast cancer and is undergoing primary wide local excision with cavity shave.

Study details
Participants in this study will undergo their usual treatment, meaning their primary wide local excision procedure. During this procedure the surgeon will take some cancerous tissue and perform the imaging test and then send the tissue for standard pathology tests.

There will be no additional involvement from participants.

If it is determined that confocal endomicroscopy can accurately determine the margins of breast cancer then it would lead to a larger study. It is hoped that the larger study will determine whether using confocal endomicroscopy during surgery can better define the surgical margin at the time of the operation and significantly reduce the likelihood of a second operation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108782 0
Prof Bruce Mann
Address 108782 0
Professor of Surgery, Director of Breast Service, Royal Melbourne and Royal Women’s Hospital.
Suite 12, The Royal Women's Hospital, Parkville, Victoria, 3052, Australia
Country 108782 0
Australia
Phone 108782 0
+61 3 93476301
Fax 108782 0
Email 108782 0
[email protected]
Contact person for public queries
Name 108783 0
Lindsay Bussau
Address 108783 0
Optiscan Pty Ltd
16 Miles St
Mulgrave, Vic, 3170
Australia
Country 108783 0
Australia
Phone 108783 0
+61 417 227 107
Fax 108783 0
Email 108783 0
[email protected]
Contact person for scientific queries
Name 108784 0
Lindsay Bussau
Address 108784 0
Optiscan Pty Ltd
16 Miles St
Mulgrave, Vic, 3170
Australia
Country 108784 0
Australia
Phone 108784 0
+61 417 227 107
Fax 108784 0
Email 108784 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a small early stage study to determine if this technology can identify involved surgical margins intraoperatively. If successful, the findings of this study will help us better define how IPD can be shared in future studies.


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.