NearWave Optical Molecular Monitoring
NCT06744465 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2026-02-17
Summary
The purpose of this study is to assess the feasibility of the NearWave optical molecular monitoring system for monitoring therapy progression and predicting pathologic complete response (pCR) of breast cancer patients undergoing neoadjuvant chemotherapy (NAC).
Conditions
- Breast Cancer
- HER2-positive Breast Cancer
- TNBC - Triple-Negative Breast Cancer
- HER2-negative Breast Cancer
- Invasive Breast Carcinoma
Interventions
- DEVICE
-
NearWave monitoring
NearWave optical molecular monitoring
Sponsors & Collaborators
-
University of Notre Dame
collaborator OTHER -
Elevate Ventures
collaborator UNKNOWN -
NearWave Corp.
collaborator UNKNOWN -
Indiana University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-07
- Primary Completion
- 2027-01-31
- Completion
- 2027-01-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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