Magnetic Occult Lesion Localization Instrument (MOLLI) Guidance System for Breast Lesion Localization

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

Intéressé(e) par cet essai?

Imprimez cette page et apportez-la chez votre médecin pour discuter de votre admissibilité à cet essai et des options de traitement. Seul votre médecin peut vous recommander pour un essai clinique.

Ressources

Société canadienne du cancer

Ces ressources sont fournies en partenariat avec Société canadienne du cancer