About this trial
This study aims to enrol approximately 103 participants presenting to the symptomatic breast unit with a breast abnormality who consent to undergo an MBI scan using the Wavelia #2 imaging system. The study uses an adaptive design to verify and validate the technical evolutions that have been integrated in the Wavelia # 2 prototype on a small patient dataset (30 patients). Once the technical performance has been established recruitment will continue to assess the clinical performance of the MBI system compared to standard of care reference imaging. The primary objectives of the study are to assess the performance of Wavelia # 2 in the detection of malignant and benign breast lesions, the sizing of malignant lesions for which post-surgery histology data will be available and the differentiation between benign and malignant breast abnormalities by means of features extracted from the MBI images.
Patient Profile
Female patients with an investigator-assessed discrete breast abnormality of size > 1cm.
Where’s this trial being run?
University Hospital Galway
Can I join this study / trial?
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QuestionsSummary Data
| Name: | Wavelia |
|---|---|
| Number: | 24-22 |
| Full Title: | Open-label, Single Site, Pilot Clinical Investigation to Assess Detectability and Sizing of Invasive Breast Cancers, Detectability of Benign Breast Lesions, Differentiation Between Malignant and Benign Breast Lesions Using Wavelia # 2 |
| Principal Investigator: | Professor Michael Kerin |
|---|---|
| Type: | Industry Sponsored |
| Sponsor: | MVG Industries SAS |
| Recruitment Started: |
Global: n/a Ireland: March 2023 |
| Global Recruitment Target: | n/a |
|---|---|
| Ireland Recruitment Target: | 103 |