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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]

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

Condition category

Condition code

Cancer

Breast

Surgery

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]

Treatment: Surgery

Intervention code [2]

Treatment: Devices

Comparator / control treatment

Not applicable

Control group

Uncontrolled

Outcomes

Primary outcome [1]

All lesions and seeds successfully removed from the participants with return of the seed to Medical Physics for disposal

Timepoint [1]

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]

A wide range of Multidisciplinary Breast Group Team members gain proctored experience and develop expertise in using the technique

Timepoint [1]

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]

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]

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?

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

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Hospital

Name

Royal Perth Hospital

Address

Wellington Street
Perth
WA 6001

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Sir Charles Gairdner Hospital

Address [1]

Hospital Avenue
Nedlands
WA 6009

Country [1]

Australia

Secondary sponsor category [2]

Commercial sector/Industry

Name [2]

MD Solutions Australasia Pty Ltd

Address [2]

40A Mason Street,
Newport, Victoria, 3015

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Royal Perth Hospital Human Research Ethics Committee

Ethics committee address [1]

Level 5 Colonial House,
Royal Perth Hospital,
GPO Box X2213 Perth WA 6001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/11/2011

Approval date [1]

18/01/2012

Ethics approval number [1]

2011/139

Summary

Brief summary

This study aims to allow us to gain more experience in the use of a technique called "ROLLIS" (Radiooccult lesion localisation using Iodine 125 Seeds), which was developed as an alternative to the use of hook wires to guide the operative removal of small abnormal areas in the breast that can't be felt, and has been in routine clinical use at the Mayo Clinic for ten years.

Who is it for?

This study expands on the inclusion criteria used for prior pilot study ACTRN12611000667910 (http://www.anzctr.org.au/trial_view.aspx?ID=342989) with addition of use of lower dose radioactive seeds (to assess whether technique is still effective) and the inclusion of lesions (a) with benign or indeterminate pathology on core biopsy and (b) use of more than one seed per participant where there are bilateral lesions and to bracket the edges of larger lesions.

Trial Details

The aim of the current study is to allow us to gain more experience in the use of this technique. Study participants will have both an I 1 25 seed, as well a hookwire inserted by a radiologist, to localise the abnormal area in their breast. The insertion of the seed will add approximately 5 minutes to the time usually needed by the radiologist to mark the abnormality. No extra discomfort will be experienced as local anaesthetic is routinely given for the standard procedure and no extra mammograms will be needed in most cases. The seed usually makes it quicker and easier for the surgeon to find and remove the abnormality. The seed is removed together with the abnormal area in the breast and pathology processing of the specimen occurs as per routine. The seed is removed from the specimen by the pathologist and given to the physicist for return to Medical Physics for disposal. Participants will be asked to complete two questionnaires, one at the first post op visit designed to assess their experience with the procedures, and the other will be posted to them, to evaluate how participants feel about the appearance o f their breast after the surgery. Completion of these will be voluntary. The literature suggests that cosmetic results may be improved with ROLLIS. We wish to assess participants experiences (positive or negative) with the technique and validate the use of these questionnaires for a future Randomised Controlled Trial to assess whether ROLLIS produces better patient outcomes compared with Wire Localised Surgery.

Trial website

Trial related presentations / publications

Publications:
- Taylor DB, Bourke AG, Hobbs MM, Dixon G, Phillips M, Saunders CM. (In press). Breast localization techniques and margin definitions used by Australian and New Zealand surgeons. ANZ Journal of Surgery. http://dx.doi.org/10.1111/ans.13632
- Bourke AG, Taylor DB, Westcott E, Hobbs M, Saunders C. (2016). Iodine-125 seeds to guide removal of impalpable breast lesions: radio-guided occult lesions localization – a pilot study. ANZ Journal of Surgery. http://dx.doi.org/10.1111/ans.13460
- Ballal H, Taylor DB, Bourke AG, Latham B, Saunders CM. (2015). Predictors of re-excision in wire-guided wide local excision for early breast cancer: a Western Australian multi-centre experience. ANZ Journal of Surgery. 85(7-8). 540-5. http://dx.doi.org/10.1111/ans.13067
- Taylor DB, Bourke AG, Westcott E, Burrage J, Latham B, Riley P, et al. (2015). Radioguided occult lesion localisation using iodine-125 seeds ('ROLLIS') for removal of impalpable breast lesions: First Australian experience. J Med Imaging Radiat Oncol. http://dx.doi.org/10.1111/1754-9485.12302
- Dissanayake S, Dissanayake D, Taylor D. (2015). Radio-guided occult lesion localisation using iodine 125 Seeds “ROLLIS” to guide surgical removal of an impalpable posterior chest wall melanoma metastasis. J Med Radiat Sci. 62(3), 230–3. http://dx.doi.org/10.1002/jmrs.125
- Dessauvagie BF, Frost FA, Sterrett GF, Hardie M, Parry J, Latham B, Taylor D, et al. (2015). Handling of radioactive seed localisation breast specimens in the histopathology laboratory: the Western Australian experience. Pathology. 47(1), 21-6. http://dx.doi.org/10.1097/PAT.0000000000000197
- Jackson L, Bourke AG, Abdul Aziz F, Taylor D. (2014) Radioactive seed localisation to guide removal of impalpable lymph nodes (Radioguided Occult Lesion Localisation using Iodine-125 seeds, "ROLLIS"). BMJ Case Rep. http://dx.doi.org/10.1136/bcr-2013-203267
Letter to the editor:
- Taylor D, Landman J. ‘Rolling out radioguided occult lesion localisation for breast tumours’: moving from ROLL to ROLLIS. (2015). Journal of Medical Radiation Sciences. 62(2):175-6. http://dx.doi.org/10.1002/jmrs.109
Poster presentations:
- Bourke A, Taylor D, Latham B, Saunders C, et al. Radioguided Occult Lesion Localisation using Iodine-125 (I-125) seeds: a simple, safe and effective technique to guide surgical removal of impalpable breast lesions: the ROLLIS Pilot Extension Study (RPES). 2014 Combined Scientific Meeting: Imaging and Radiation in Personalised Medicine; 4-7 Sep 2014; Melbourne Convention and Exhibition Centre. RANZCR; 2014: R-0073.
- Riley PJ, Bourke AG, Taylor D, Westcott E, Jose C, Ballal H, et al. Steps to success with ROLLIS: how to commence using Radioguided Occult Lesion Localisation with I-125 seeds for removal of impalpable breast lesions (Poster Presentation). European Congress of Radiology 2012.
- Taylor D, Bourke A, Hobbs M, Dixon G, Phillips M, Saunders C. How do ANZ surgeons localise impalpable cancers? 2014 Australasian Breast Congress.
- Taylor D, Bourke A, Hobbs M, Dixon G, Saunders C. Evaluation of methods used to guide breast conserving surgery by Australian and New Zealand breast surgeons. Australasian Breast Congress; 9-11 Oct 2014; Gold Coast, Australia.
Oral presentations and workshops:
- Bourke AG et al. New localisation tools – Radioguided-Occult Lesion Localisation using 125-Iodine Seeds (ROLLIS) Breast Lesions. Scientific Meeting of the Graduates of Royal College of Surgeons in Ireland, 27th August 2015.
- Bourke AG et al. “ROLLIS” Radioguided Occult Lesion Localisation using Iodine-125 (I-125) Seeds for removal of impalpable breast lesions: first Australian results. Symposium Cancer Council WA Nov 2014.
- Taylor D. Radioguided Occult Lesion Localisation using Iodine 125 Seeds for removal of impalpable breast lesions, first Australian results” (Recipient of the award for best oral presentation) Australasian Breast Congress, Australasian Society for Breast Diseases and BreastSurgANZ Society Meeting, Gold Coast, 9-11 October 2014.

Public notes

Contacts

Principal investigator

Name

Dr Donna TAYLOR

Address

Department of Diagnostic and Interventional Radiology Royal Perth Hospital PO Box X2213 GPO Perth WA 6001

Country

Australia

Phone

61 8 92242125

Fax

61 8 92243764

donna.taylor@health.wa.gov.au

Contact person for public queries

Name

Dr Donna Taylor

Address

Department of Diagnostic and Interventional Radiology
Royal Perth Hospital
PO Box X2213
GPO Perth
WA 6001

Country

Australia

Phone

61 8 92242125

Fax

61 8 92243764

donna.taylor@health.wa.gov.au

Contact person for scientific queries

Name

Dr Donna Taylor

Address

Department of Diagnostic and Interventional Radiology
Royal Perth Hospital
PO Box X2213
GPO Perth
WA 6001

Country

Australia

Phone

61 8 92242125

Fax

61 8 92243764

donna.taylor@health.wa.gov.au

No information has been provided regarding IPD availability

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No Supporting Document Provided

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