Titre officiel
A Registry Study Evaluating the Magnetic Occult Lesion Localization Instrument (MOLLI) Guidance System for Breast Lesion Localization
Sommaire:
L’essai proposé est de type non randomisé,
multicentrique et à groupes séquentiels, et vise à évaluer les résultats
cliniques, sanitaires et économiques du traitement mené avec le système et
procédé de localisation et d’imagerie de lésion occulte magnétique, un
instrument approuvé pour la chirurgie mammaire conservatrice (CMC) chez les
patientes présentant des lésions non palpables. Toutes les patientes présentant
un trouble mammaire et qui, de l’avis de leur médecin, sont de bonnes candidates
à la chirurgie mammaire conservatrice sont admissibles à l’étude. Les patientes
seront potentiellement recrutées dans quatre sites chirurgicaux
(Sunnybrook Health Sciences Centre, le site principal, Princess Margaret Cancer
Centre, St. Joseph’s Healthcare, et North York General Hospital) sur une
période de 2 ans. Les mesures des résultats liés aux patientes et au
système seront d’abord recueillies selon la norme de soins spécifique au centre
(localisation filoguidée ou localisation radioactive des graines pour la CMC)
afin d’établir une base de référence. Par la suite, les centres passeront au
système et procédé de localisation et d’imagerie de lésion occulte magnétique,
en consignant les résultats correspondants qui seront utilisés pour la comparaison
temporelle. L’objectif global de cette étude est d’évaluer les résultats
cliniques, sanitaires et économiques du système et procédé de localisation et d’imagerie
de lésion occulte magnétique par rapport aux approches de soins standard.
Description de l'essai
Primary Outcome:
- MOLLI Localization Success Rate
Secondary Outcome:
- Specimen Margin Positivity
- Re-excision rates
- Duration of Excision
- Duration of Implantation
- Cost-effectiveness of MOLLI
- Hospital Anxiety and Depression Scale (HADS) to evaluate anxiety and depression
- State-Trait Anxiety Inventory (STAI) to evaluate anxiety
- Anxiety with Radiation
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 tumour 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 centre and/or
borders of the tumour. 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 centre 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 tumour; during the procedure
the surgeon uses a novel hand-held probe to intra-operatively detect the position of this
seed and remove the tumour.
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.
Voir cet essai sur ClinicalTrials.gov
