BACKGROUND INFORMATION
In contemporary breast cancer management, more than 70% of breast cancer patients are
eligible for - and select - breast-conserving therapy (BCS). However, issues with
cosmesis, patient experience, and treatment workflow efficiency during the therapeutic
process have considerable room for improvement.
BCS consists of a surgical procedure whereby the suspicious tumor and a rim of
surrounding normal tissue are removed. Up to one-third of all diagnosed breast cancers
are non-palpable,and require some form of pre-operative localization to guide precise
surgical excision. Currently, options for localization of non-palpable lesions are
suboptimal in terms of patient experience, healthcare system resource utilization, and
cost-effectiveness.
One of the most common approaches is radioactive seed localization (RSL). RSL consists of
insertion of a small radioactive seed under ultrasound guidance to mark the center and/or
borders of the tumor. During the procedure the surgeon uses a hand-held probe to detect
the seed and guide surgical excision of the lesion intra-operatively. While RSL is
effective the use of a radioactive source is and poses many challenges for patients and
staff. Another common approach is wired-guided localization (WGL). WGL involves
implantation of a hooked wire to mark the center or outer edges of the lesion. Due to
modest cost and relative ease of use, WGL use is widespread, however disadvantages
include significant patient discomfort, possible migration of the implanted wire, and
potential difficulties in localizing axillary lymph nodes.
WHAT ARE THE INVESTIGATORS DOING?
The investigative team of surgeons and scientists are examining an alternative approach
to BCS called magnetic occult lesion localization and imaging (MOLLI). Analogous to RSL,
this procedure involves implantation of a small passive magnetic seed - under ultrasound
or mammographic imaging guidance - directly into or surrounding the tumor; during the
procedure the surgeon uses a novel hand-held probe to intra-operatively detect the
position of this seed and remove the tumor.
WHY IS THE STUDY BEING CONDUCTED?
MOLLI offers many of the same benefits as RSL but without any radiation. MOLLI also has
the potential to be more effective and accurate than other localization methods. MOLLI
has recently been evaluated as part of a phase I clinical trial and was demonstrated to
be a safe and effective localization technology. The goal for the current trial is to
evaluate clinical and health economic outcomes with MOLLI compared to standard-of-care
approaches to help improve access to a wireless, low-cost, but effective breast lesion
localization technology for breast cancer patients.
WHAT WILL HAPPEN DURING THE STUDY?
As part of this study, researchers will 1) evaluate identify barriers and facilitators
related to MOLLI based on feedback from clinical staff, 2) demonstrate cost-effectiveness
of MOLLI and 3) gather information on the participants' experience with the MOLLI seed.
At each site, the first 25 participants will be treated with the standard of care for BCS
(RSL or WGL), and the second 25 participants will be treated with MOLLI.
ARE THERE SIDE EFFECTS?
No side effects are expected from the study treatments. Possible risks associated with
using MOLLI include:
A small risk of bleeding A remote risk of allergic reaction to nickel contained in the
MOLLI seeds
WHAT WILL HAPPEN AFTER THE STUDY?
Participants may be contacted by a study team member up to and including 16 weeks (6.5
months) after the procedure to take part in a short telephone questionnaire. The
questionnaire should take no more than 5 minutes to complete.
