Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000221853
Ethics application status
Approved
Date submitted
23/12/2011
Date registered
22/02/2012
Date last updated
5/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
ROLLIS: Radioguided Occult Lesion Localisation using Iodine Seeds to localise impalpable breast lesions: The Pilot Extension Study
Scientific title
ROLLIS: Radioguided Occult Lesion Localisation using Iodine Seeds to localise impalpable breast lesions: The Pilot Extension Study
Secondary ID [1] 273326 0
U1111-1128-3564
Universal Trial Number (UTN)
U1111-1127-4903
Trial acronym
ROLLIS EXT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 279096 0
Condition category
Condition code
Cancer 279285 279285 0 0
Breast
Surgery 285870 285870 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study builds on the prior ROLLIS pilot study http://www.anzctr.org.au/ACTRN12611000667910.aspx
Participants will have a tiny metal seed containing a small amount of Iodine 125 inserted into their breast lesion by a radiologist using imaging guidance. The seed will be inserted on the morning of the day of surgery and it usually only adds a few minutes to the overall radiology procedure time (usually around an hour). The seed consists of a tiny (4mm) metal capsule within which there is a very low dose of the radioisotope Iodine 125 (in a solid form not a liquid). The conventional method of marking the abnormal area in the breast is by putting a hook wire into it. This will still be performed in addition to the insertion of the seed, to provide a back up method of localisation for the surgeon until the team has built up expertise and experience in using the seed alone to find the breast lesion for removal. The signal given out by the seed is detected within the breast by the surgeon using a hand held gamma detector, which makes a noise in response proportionate to the proximity of the detector to the seed within the breast. The seed and the abnormal area of the breast will be removed together and sent for pathology analysis. The seeds are returned to the Medical Physics Department at the Hospitals for safe disposal and are only for single use. Having the seed in place is likely to make your time in theatre less. Time spent in theatre for the operation will vary depending on where the abnormal area is in your breast and other factors.
Intervention code [1] 283674 0
Treatment: Surgery
Intervention code [2] 283675 0
Treatment: Devices
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279905 0
All lesions and seeds successfully removed from the participants with return of the seed to Medical Physics for disposal
Timepoint [1] 279905 0
Removal of lesion assessed at time of pathology review of specimen the next working day after surgery, pathologist describes lesion as being present and for malignant lesions, whether any margins are <10mm.
Removal of Seed assessed at time of surgery by finding high count levels within specimen using gamma probe, and visualisation of seed within specimen on specimen radiograph Physicist documents collection of all seeds on the day the specimen is sectioned by the pathologist. This is usually the next working day following the day of surgery.
Secondary outcome [1] 294732 0
A wide range of Multidisciplinary Breast Group Team members gain proctored experience and develop expertise in using the technique
Timepoint [1] 294732 0
Radiologist, surgeon (on day of surgery) and pathologist (on day of seed removal) complete questionnaires relating to ease of performing the procedure and the degree to which they depended on the wire or the seed to locate an remove the lesion.
Secondary outcome [2] 295695 0
Participants are asked to complete two questionnaires: the first at the time of the surgical follow-up appointment is to assess their experience with the procedure
The second is posted to them 6 months later and is to assess how they feel about the cosmetic result of their surgery
Timepoint [2] 295695 0
One week post op
Six months post op

Eligibility
Key inclusion criteria
1. Women aged over 40 years
2. Non-palpable breast tumour
4. Participant eligible for breast conserving surgery (BCS)
based on clinical and radiologic evaluation
6. Benign impalpable lesions, where participant requests
lesion be removed
7. Intraductal lesions (papillomas)
8. Lesions that are histologically “indeterminate” on core
biopsy ( histology shows concerning features and removal
of further tissue for assessment to exclude cancer)
9. Insertion of up to two seeds per participant (either
to “bracket” larger or elongated lesions or for multiple
lesions (two in one breast or one in each breast)
10.Periareolar lesions (providing the participant does not
require scintigraphy for sentinel node biopsy)
Minimum age
40 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Male patient
2. Female, age less than 40 years
3. Pregnancy or lactation
4. Periareolar lesion (where sentinel lymph node localization is
required)
5. Contraindication to breast conserving surgery
6. Recent Nuclear Medicine or PET radioisotope administration that may adversely affect the procedure (isotopes with long half life eg gallium 67, thallium )

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)
Patients attending the Breast Clinics at RPH and SCGH who meet the eligibility criteria will be invited to participate by their treating surgeon and given a PCIF to take home. They will be contacted by the Principal Investigator by phone to see if they wish to participate and if so, informed consent will be obtained by the PI or an AI when they attend the hospital for their pre-anaesthetic visit.
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
1/03/2012
Actual
1/11/2012
Date of last participant enrolment
Anticipated
Actual
31/08/2013
Date of last data collection
Anticipated
Actual
7/03/2014
Sample size
Target
120
Accrual to date
Final
99
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 284757 0
Self funded/Unfunded
Name [1] 284757 0
Country [1] 284757 0
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
Wellington Street
Perth
WA 6001
Country
Australia
Secondary sponsor category [1] 269114 0
Hospital
Name [1] 269114 0
Sir Charles Gairdner Hospital
Address [1] 269114 0
Hospital Avenue
Nedlands
WA 6009
Country [1] 269114 0
Australia
Secondary sponsor category [2] 283649 0
Commercial sector/Industry
Name [2] 283649 0
MD Solutions Australasia Pty Ltd
Address [2] 283649 0
40A Mason Street,
Newport, Victoria, 3015
Country [2] 283649 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286398 0
The Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 286398 0
Ethics committee country [1] 286398 0
Australia
Date submitted for ethics approval [1] 286398 0
02/11/2011
Approval date [1] 286398 0
18/01/2012
Ethics approval number [1] 286398 0
2011/139

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

Contacts
Principal investigator
Name 33350 0
Dr Donna TAYLOR
Address 33350 0
Department of Diagnostic and Interventional Radiology Royal Perth Hospital PO Box X2213 GPO Perth WA 6001
Country 33350 0
Australia
Phone 33350 0
61 8 92242125
Fax 33350 0
61 8 92243764
Email 33350 0
[email protected]
Contact person for public queries
Name 16597 0
Dr Donna Taylor
Address 16597 0
Department of Diagnostic and Interventional Radiology
Royal Perth Hospital
PO Box X2213
GPO Perth
WA 6001
Country 16597 0
Australia
Phone 16597 0
61 8 92242125
Fax 16597 0
61 8 92243764
Email 16597 0
[email protected]
Contact person for scientific queries
Name 7525 0
Dr Donna Taylor
Address 7525 0
Department of Diagnostic and Interventional Radiology
Royal Perth Hospital
PO Box X2213
GPO Perth
WA 6001
Country 7525 0
Australia
Phone 7525 0
61 8 92242125
Fax 7525 0
61 8 92243764
Email 7525 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.