Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000667910
Ethics application status
Approved
Date submitted
13/06/2011
Date registered
1/07/2011
Date last updated
30/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
PILOT STUDY: I-125 seeds can be safely and accurately used for radioguided occult lesion localisation and removal of impalpable breast cancers ("ROLLIS")
Scientific title
PILOT STUDY: I-125 seeds can be safely and accurately used for radioguided occult lesion localisation and removal of impalpable breast cancers ("ROLLIS")
Secondary ID [1] 262482 0
Nil
Universal Trial Number (UTN)
U1111-1121-8082
Trial acronym
ROLLIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer 267971 0
Condition category
Condition code
Cancer 268101 268101 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The "seed" consists of a small titanium capsule which contains a small quantity of very low dose radioactivity in the form of the radioisotope Iodine 125 (I-125). The I-125 is in a solid state within the seed, covalently bound to a silver wire. The seed is placed in the breast within or next to the abnormal area by the radiologist, using ultrasound or stereotactic mammographic guidance. The Iodine 125 within the seed emits a low energy gamma photon which is detected by the surgeon in theatre, using a hand held gamma probe. The gamma probe makes a noise, the volume of which is proportional to the amount of signal that it picks up from the seed. The highest number of counts (maximum noise) corresponds to the location of the seed and therefore the abnormal area in the breast. The probe is very directionally sensitive and is used by the surgeon to not only make his/her incision in the optimal position relative to the abnormal area but also to assist them to remove the abnormality together with a small surrounding cuff of normal tissue.
All participants will also have the standard localisation method, which is the insertion of a hook-wire as a "back-up" during the introduction of this new technique.
Intervention code [1] 266658 0
Treatment: Surgery
Intervention code [2] 266661 0
Treatment: Devices
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266850 0
successful removal of the impalpable breast cancers that have been localised using the I 125 seed
Timepoint [1] 266850 0
assessed at time of pathology review of specimen the next working day after surgery, pathologist describes lesion as being present
Primary outcome [2] 266851 0
successful removal of I-125 seeds inserted for lesion localisation and return to physicist for safe storage
Timepoint [2] 266851 0
assessed at time of surgery by finding high count levels within specimen using gamma probe, visualisation of seed within specimen on specimen radiograph, seed returned to physicist after removal by pathologist on the day of specimen processing
Secondary outcome [1] 276502 0
Radiologist, surgeon and pathologist gain expertise in using this technique
Timepoint [1] 276502 0
assessed by review of questionnaires relating to ease of performing the procedure on the day of surgery

Eligibility
Key inclusion criteria
Women aged over 40 years with good life expectancy
A signed and dated written informed consent is obtained prior to participation
Histologically confirmed invasive or in situ breast carcinoma
Non-palpable breast tumour
Single lesion
Candidate for breast conserving surgery (BCS) based on clinical and radiologic evaluation
Minimum age
40 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Male patient
Female, age less than 40 years
Pregnancy or lactation
Periareolar lesion
Contraindication to breast conserving surgery
Surgery after 4pm
Nuclear Medicine or PET radioisotope administration that may adversely affect the procedure

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible women will be given a patient information sheet and invited to participate in the trial by their surgeon.
All participants will have the standard localisation procedure as well as the new method of localistion performed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
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
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2011
Actual
4/08/2011
Date of last participant enrolment
Anticipated
Actual
11/04/2015
Date of last data collection
Anticipated
Actual
11/04/2015
Sample size
Target
20
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 6754 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [2] 6755 0
Royal Perth Hospital - Perth
Recruitment hospital [3] 6756 0
St John of God Hospital, Subiaco - Subiaco
Recruitment postcode(s) [1] 14398 0
6009 - Nedlands
Recruitment postcode(s) [2] 14399 0
6000 - Perth
Recruitment postcode(s) [3] 14400 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 267307 0
Self funded/Unfunded
Name [1] 267307 0
Country [1] 267307 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Verdun Street
Nedlands
WA 6009
Country
Australia
Secondary sponsor category [1] 266224 0
Hospital
Name [1] 266224 0
Royal Perth Hospital
Address [1] 266224 0
Wellington Street
Perth
WA 6001
Country [1] 266224 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269142 0
Sir Charles Gairdner Hospital Human Research Ethics Committee
Ethics committee address [1] 269142 0
Ethics committee country [1] 269142 0
Australia
Date submitted for ethics approval [1] 269142 0
Approval date [1] 269142 0
15/04/2011
Ethics approval number [1] 269142 0
2011-025
Ethics committee name [2] 269143 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [2] 269143 0
Ethics committee country [2] 269143 0
Australia
Date submitted for ethics approval [2] 269143 0
Approval date [2] 269143 0
12/05/2011
Ethics approval number [2] 269143 0
2011.007
Ethics committee name [3] 296055 0
St John of God Health Care Ethics Committee
Ethics committee address [3] 296055 0
Ethics committee country [3] 296055 0
Australia
Date submitted for ethics approval [3] 296055 0
07/01/2015
Approval date [3] 296055 0
29/05/2014
Ethics approval number [3] 296055 0
672

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32667 0
Dr Anita Bourke
Address 32667 0
Breast Centre, G Block 1st Floor
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands WA 6009
Country 32667 0
Australia
Phone 32667 0
+18 6547 2233
Fax 32667 0
Email 32667 0
[email protected]
Contact person for public queries
Name 15914 0
Dr Donna Taylor
Address 15914 0
Department of Diagnostic and Interventional Radiology
Royal Perth Hospital
PO Box X2213
GPO Perth 6001
Country 15914 0
Australia
Phone 15914 0
61 8 92242125
Fax 15914 0
61 8 92243764
Email 15914 0
[email protected]
Contact person for scientific queries
Name 6842 0
Dr Donna Taylor
Address 6842 0
As above
Country 6842 0
Australia
Phone 6842 0
61 8 92242125
Fax 6842 0
61 8 92243764
Email 6842 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.