Magnetic Occult Lesion Localization and Imaging (MOLLI) (MOLLI)
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|ClinicalTrials.gov Identifier: NCT03660137|
Recruitment Status : Recruiting
First Posted : September 6, 2018
Last Update Posted : September 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms||Device: MOLLI Localization||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All patients will receive both RSL and MOLLI-guided lumpectomy surgery|
|Masking:||None (Open Label)|
|Official Title:||Magnetic Occult Lesion Localization and Imaging (MOLLI) for Non-palpable Breast Lesions: a Phase 0 Pilot Feasibility Trial|
|Actual Study Start Date :||May 28, 2018|
|Estimated Primary Completion Date :||September 1, 2019|
|Estimated Study Completion Date :||October 1, 2019|
Experimental: MOLLI Localization
All patients will be implanted with a MOLLI magnetic seed in addition to the standard-of-care RSL seed. Both systems will be use to localize the respective seeds during the lumpectomy surgery.
Device: MOLLI Localization
All patients will also be implanted with an additional MOLLI seed using a specialized introducer needle. A specialized MOLLI probe will be used to find the magnetic seed during the lumpectomy surgery.
- MOLLI Localization Success Rate [ Time Frame: Day 3 post marker implantation (during surgical excision) ]The primary goal of this study is to determine the success rate of localizing the MOLLI seed, along with subsequent accurate removal under MOLLI guidance alongside RSL.
- Duration of Implantation [ Time Frame: Day 0 (during marker implantation) ]The duration of MOLLI marker implantation as carried out by the radiologist.
- Specimen Margin Positivity [ Time Frame: Day 30 ]As reported by anatomical pathology, this metric will evaluate if the excised specimen has negative margins or positive margins.
- Re-excision rates at 30 days [ Time Frame: Day 30 ]Follow-up will determine if patients required a re-excision / re-operation after determination of positive margin status.
- European Quality-of-Life Questionnaire - 5 Dimensions (EQ5D) questionnaire to evaluate quality-of-life [ Time Frame: Day 0 (baseline), Day 30 (1 month FU) ]EQ5D will evaluate overall quality of life pre- and post-MOLLI surgery. Five questions will be evaluated on a 3 point scale (1 being the worst, 3 being the best). Evaluations will occur prior to implantation and approximately 1 month following surgical excision. The lowest score achievable is 5, the highest score achievable is 15.
- Duration of Excision [ Time Frame: Day 3 (during surgery) ]The time required to perform surgical excision of the lesion and MOLLI marker.
- European Quality-of-Life Visual Analogue Scale (EQVAS) questionnaire to evaluate quality-of-life [ Time Frame: Day 0 (baseline), Day 30 (1 month FU) ]EQVAS will evaluate overall quality of life pre- and post-MOLLI surgery. Patients will be asked to rank their overall health on a scale from 0 to 100 (0 being the worst, 100 being the best). The lowest total score is 0, the highest achievable total score is 100.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03660137
|Contact: Ananth Ravi, PhD||416-480-6100 ext firstname.lastname@example.org|
|Contact: Alexandru M Nicolae, MScemail@example.com|
|Sunnybrook Health Sciences Centre||Recruiting|
|Toronto, Ontario, Canada, M4N-3M5|
|Contact: Ananth Ravi, PhD 416-480-5000 ext 1092 firstname.lastname@example.org|
|Principal Investigator:||Ananth Ravi, PhD||Sunnybrook Research Institute|