A Clinical Investigation to Evaluate Microwave Imaging Via MammoWave® in a Population-based Screening Program for Early Breast Cancer Detection

Launched by UMBRIA BIOENGINEERING TECHNOLOGIES · Feb 26, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new way to detect early breast cancer using a technology called MammoWave. The goal is to see how effective this method is at finding breast cancer in women who are participating in regular screening programs. The researchers want to confirm that MammoWave can accurately identify breast cancer in at least 75% of cases (sensitivity) and can correctly identify women without breast cancer in at least 90% of cases (specificity). The trial is currently recruiting women aged 45 to 74 who are at average risk for breast cancer and who do not have any current symptoms.

To participate, women must have had a recent mammogram or have one scheduled on the same day as the MammoWave test. However, women with breast implants, those with known breast cancer genes, or those who have had breast cancer before, among other criteria, cannot join. Participants can expect to undergo the MammoWave test, which is a non-invasive procedure, following their mammogram. This trial is important because it could lead to better early detection methods for breast cancer, which is crucial for effective treatment.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women aged between 45 and 74 years
• • Asymptomatic
• • Signed informed consent form before starting any study activity
• • Average risk of BC (every woman except those with know BRCA1, 2, TP53, and/or previous BC)
• • Mammographic test, either 2D FFDM or 3D Digital Breast Tomosynthesis (DBT) (collecting oblique mediolateral projection \[MLO\] of the right breast, craniocaudal projection \[CC\] of the right breast, MLO projection of the left breast, CC projection of the left breast), performed within the past month with available results or planned to be performed in the same day of the MammoWave test or in the subsequent days
• • Spontaneous willingness to comply with CIP and recommendations
• Exclusion Criteria:
• • Woman with breast prostheses
• • Women with symptoms or some sign of suspected BC
• • Women with BRCA1, 2, TP53 or previous BC
• • Pregnant women
• • Women who do not have mammographic manifestation of the tumor (known occult breast tumor with only axillar manifestation)
• • Women with breast size larger than the largest MammoWave cup size