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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]

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

Condition category

Condition code

Cancer

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]

Treatment: Surgery

Intervention code [2]

Treatment: Devices

Comparator / control treatment

Not applicable

Control group

Uncontrolled

Outcomes

Primary outcome [1]

successful removal of the impalpable breast cancers that have been localised using the I 125 seed

Timepoint [1]

assessed at time of pathology review of specimen the next working day after surgery, pathologist describes lesion as being present

Primary outcome [2]

successful removal of I-125 seeds inserted for lesion localisation and return to physicist for safe storage

Timepoint [2]

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]

Radiologist, surgeon and pathologist gain expertise in using this technique

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Sir Charles Gairdner Hospital - Nedlands

Recruitment hospital [2]

Royal Perth Hospital - Perth

Recruitment hospital [3]

St John of God Hospital, Subiaco - Subiaco

Recruitment postcode(s) [1]

6009 - Nedlands

Recruitment postcode(s) [2]

6000 - Perth

Recruitment postcode(s) [3]

6008 - Subiaco

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Australia

Primary sponsor type

Hospital

Name

Sir Charles Gairdner Hospital

Address

Verdun Street
Nedlands
WA 6009

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Royal Perth Hospital

Address [1]

Wellington Street
Perth
WA 6001

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sir Charles Gairdner Hospital Human Research Ethics Committee

Ethics committee address [1]

Level 2, A Block, Sir Charles Gairdner Hospital,  Hospital Avenue, Nedlands WA 6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

15/04/2011

Ethics approval number [1]

2011-025

Ethics committee name [2]

Royal Perth Hospital Human Research Ethics Committee

Ethics committee address [2]

Level 5, Colonial House, Royal Perth Hospital, GPO Box 2212, Perth, WA 601

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

12/05/2011

Ethics approval number [2]

2011.007

Ethics committee name [3]

St John of God Health Care Ethics Committee

Ethics committee address [3]

Level 3, St John of God House, 177-179 Cambridge St, WEMBLEY WA 6014

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

07/01/2015

Approval date [3]

29/05/2014

Ethics approval number [3]

672

Summary

Brief summary

When a cancer needs to be removed after a biopsy (and the surgeon cannot feel it) it is normally localised and marked for the surgeon by a radiologist who places a fine wire into the abnormality using ultrasound or x-ray guidance, sterile conditions and after using local anaesthetic (to numb the area). This “wire localization procedure” is done on the day of the operation and has been the standard treatment used at this hospital for over 20 years. 
A gentle mammogram picture is necessary to check the position of the wire. The surgeon uses the wire to guide them during the operation and the abnormality and the wire are removed whilst you are asleep. 

The localization procedure can be difficult and time consuming. Sometimes the wire can be difficult to put in, especially if the breast tissue is very firm. Occasionally the tip of the wire is not right next to the abnormality which means that another wire needs to be put in. 
The direction the Radiologist has to take to place the wire may not give the best approach for the surgeon and the incision may be some distance from the abnormality. Sometimes after the pathologist has looked at the removed tissue, it is found that the abnormality has not been completely removed, which means that a further operation is needed to make sure all the abnormal tissue has been removed.

More recently surgeons overseas have been using an alternative way of marking small breast abnormalities using a low dose radioactive “seed” which contains Iodine 125. This is placed into or next to the abnormality either on the day before or the day of the surgery. The surgeon then uses a special hand held probe that can detect the signal given out by the seed to find the abnormal area within the breast. The probe makes a noise which becomes louder the closer it is to the abnormality and gives continuous feed back to the surgeon so that they can adjust their position and to help make sure as much of the abnormal area as possible is removed during the one operation.
Studies suggest that with this technique the abnormality is more often completely removed without the need for a further operation and because it is easier for the surgeon to find the abnormality,  the appearances of the breast after the operation may be better than if a wire localization of the lesion had been performed.

The technique of inserting the radioactive seed and removing it is reported to be very easy with very few complications. 
Our surgeons are already trained in the technique of using the special hand held probe to find and remove lymph glands after the injection of a radioactive liquid and have been doing this for many years (sentinel lymph node removal). The use of the probe for detecting and removing the seed will be a similar technique.
Our radiologists are also already very experienced in placing small metallic markers (similar to the seeds apart from being non radioactive) into the breast after biopsying small abnormalities. 

For the 20 participants in this study, we are planning to use the standard wire localization as well as placing a radioactive seed into the breast abnormality to enable us to gain experience with the new technique. The wire will be there as a backup to make sure your abnormality is removed

We will review our results at the end of the study to see if we had any problems with the new technique that we need to improve on. If, as we anticipate there are no problems, we plan to start a large research trial to compare the results of surgery using the seeds compared with the wire to localize small breast cancers.

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 Anita Bourke

Address

Breast Centre, G Block 1st Floor
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands WA 6009

Country

Australia

Phone

+18 6547 2233

Fax

[email protected]

Contact person for public queries

Name

Dr Donna Taylor

Address

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

Country

Australia

Phone

61 8 92242125

Fax

61 8 92243764

[email protected]

Contact person for scientific queries

Name

Dr Donna Taylor

Address

As above

Country

Australia

Phone

61 8 92242125

Fax

61 8 92243764

[email protected]

No information has been provided regarding IPD availability

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No Supporting Document Provided

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