None listed
Conditions
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.
Interventions
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 ver
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.
Sponsors
Royal Perth Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
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)
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 )
Outcome results
None listed