Magnetic Occult Lesion Localization and Imaging (MOLLI)

Titre officiel

Magnetic Occult Lesion Localization and Imaging (MOLLI) for Non-palpable Breast Lesions: a Phase 0 Pilot Feasibility Trial

Sommaire:

Il s’agit d’une étude sans répartition aléatoire et à groupe unique portant sur la faisabilité technique et l’innocuité de localisation et imagerie magnétiques des lésions occultes [magnetic occult lesion localization and imaging (MOLLI)] en vue d’une chirurgie mammaire conservatrice chez des 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. Toutes les patientes devront se soumettre au procédé courant de localisation à la bille radioactive aux fins de guidage chirurgical ainsi qu’à un examen par IRM pour la localisation de lésions occultes. Cette étude de faisabilité sera menée seulement dans un établissement de soins tertiaires (Centre des sciences de la santé Sunnybrook, Toronto, Ontario [Canada]) sur une période d’un an. Le principal critère d’évaluation de cette étude est le taux de localisation à la bille au moyen de l’IRM utilisée pour la localisation de lésions occultes.

Description de l'essai

Primary Outcome:

  • MOLLI Localization Success Rate
Secondary Outcome:
  • Duration of Implantation
  • Specimen Margin Positivity
  • Re-excision rates at 30 days
  • European Quality-of-Life Questionnaire - 5 Dimensions (EQ5D) questionnaire to evaluate quality-of-life
  • Duration of Excision
  • European Quality-of-Life Visual Analogue Scale (EQVAS) questionnaire to evaluate quality-of-life

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.

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 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.

WHAT WILL HAPPEN DURING THE STUDY? As part of this study, researchers will look at how safe the MOLLI system is in finding the tumour in the participant's breast. The study will also gather information on the participant's experience of having the MOLLI seed placed. Participants will undergo both MOLLI as well as the current standard method, RSL, ensuring that the area of concern will be accurately located and then removed. Approximately 20 women will take part in this study

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 following both visits

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 your 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

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