PILOT STUDY: I-125 seeds can be safely and accurately used for radioguided occult lesion localisation and removal of impalpable breast cancers ("ROLLIS")

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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.

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