ROLLIS trial

14 June 2013

Purpose

To investigate an alternative method of marking nonpalpable breast cancers to guide surgery.

Scientific Title

Can the use of low dose radioactive seeds to guide surgical removal of small areas of abnormal breast tissue reduce the rate of second operation compared with standard hook-wire technique? (ROLLIS RCT: Radio-guided Occult Lesion Localisation using Iodine125 Seeds).

Background

The number of non-palpable breast cancers requiring pre-operative image-guided localisation continues to increase due to breast screening and the use of pre-operative chemotherapy. Hook wire localisation (HWL) has been standard of care since the 1970s, but is associated with a high positive margin (20-40%) and re-excision (30-50%) rates. Other disadvantages of HWL include technical difficulties (e.g. wire transection and migration), inefficient use of radiology bookings, and impact on theatre time.

The new method trialed in Australian and New Zealand (Waikato only) is called “ROLLIS”, which stands for Radioguided Occult Lesion Localisation using low activity Iodine 125 Seeds. Instead of using a hook-wire to localise the abnormality, the radiologist inserts a very low dose of radioactive Iodine-125 (I-125) seed into the abnormal area. During the surgery, a handheld detecting “probe” is used by the surgeon to detect the radioactive signal produced by the seed. The seed and the abnormal area is then removed. Other international clinical trials suggest that the ROLLIS method offers benefits to patients that include being able to mark the abnormality as an outpatient procedure up to eight days before surgery. It can also make the surgery easier and faster to perform with a better chance of removing all the abnormality in one operation.

Results

This trial completed in May, 2019 and a publication of results is pending.