Radioguided Occult Lesion Localisation using Iodine 125 Seeds
The Ladybird Foundation is raising urgently needed funds to allow the completion of the ROLLIS Project. This clinical trial is already underway, but the shortfall in funding means we need your help to reach our fundraising target of $200,000.
Since taking on this challenge, The Ladybird Foundation has raised and granted $110,000 to the ROLLIS Project, enabling this very important clinical trial to continue to enrol Western Australian women as participants.
The ROLLIS Project
What is the ROLLIS Project?
The ROLLIS Project involves a trial of 650 breast cancer patients and has the potential to change the treatment of impalpable breast cancers.
Purpose: Comparing the use of low dose radioactive seeds to the standard technique to guide the localisation of impalpable breast cancer in women undergoing breast-conserving surgery.
Technique: The ROLLIS technique is used to guide breast-conserving surgery for small, impalpable (i.e. the surgeon can’t feel it) breast cancers. It involves inserting a tiny low-dose radioactive iodine-labelled seed into the patient’s cancer under local anesthesia with imaging guidance. The surgeon uses a hand-held probe to locate the seed at the time of the surgery.
Researchers: The Project is being led by WA Clinicians:
- Professor Christobel Saunders (Breast Surgeon)
- Dr Donna Taylor (Radiologist)
- Dr Anita Bourke (Radiologist).
When an abnormal area in the breast needs to be removed after a needle biopsy (and the surgeon cannot feel it), the abnormal area is localized. We are comparing two different localization techniques in this study. Participants will be randomly assigned to one of two techniques:
- The ROLLIS procedure, followed by breast conserving surgery within 8 days. This involves the surgeon using the seed to guide removal of the impalpable cancer.
- Hook-wire guided localization (the standard treatment). This is when a hook-wire is placed in the breast on the day of breast conserving surgery by a radiologist.
Participants are followed for up to 5 years post-surgery in order to evaluate clinical and cosmetic outcomes, disease recurrence and patient satisfaction. A cost benefit analysis will also be undertaken.
This technique has shown great promise with studies already carried out in the USA and Europe suggesting it will significantly reduce the number of women who need more than one operation to ensure all cancer is removed, compared to the traditional hook-wire technique where almost one in three women needs more than one breast cancer operation (“re-excision”).
Re-excision causes significant anxiety and distress to a woman at a critical phase in her cancer journey, as well as being a consequent burden on health resources.
The ROLLIS Project will provide the high-quality evidence now required to confirm if ROLLIS is the better technique.