NearWave Optical Molecular Monitoring
Part of paid clinical trials in Indianapolis, Indiana.
- Sponsor
- Indiana University
- Study ID
- NCT06744465
- Status
- Recruiting
Conditions
- Breast Cancer
- HER2-negative Breast Cancer
- HER2-positive Breast Cancer
- Invasive Breast Carcinoma
- TNBC - Triple-Negative Breast Cancer
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- NearWave monitoring — DEVICENearWave optical molecular monitoring
Study Details
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).
Key Dates
- First listed
- Dec 20, 2024
- Start date
- Mar 7, 2025
- Status verified
- Feb 2026
- Primary completion
- Jan 31, 2027
- Completion
- Jan 31, 2027
Study Design
- Enrollment
- 15 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- OTHER
Arms
- Experimental: NearWave monitoringBreast cancer patients receiving neoadjuvant chemotherapy treatment followed by surgery will be monitored by a noninvasive handheld imaging device before, during and after chemotherapy.
Primary Outcome Measure
Feasibility of using NearWave imaging as a monitoring system [ Time Frame: Over approximately 5 months; baseline, mid way through treatment, and at last dose of clinical chemotherapy/prior to clinical surgery ]
Central Contacts
- Tarah J Ballinger, MD(317) 944-3553
- Xin Bryan, RN317-312-2793
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Indiana University Simon Comprehensive Cancer Center | Indianapolis | Indiana | 46202 | Tarah J Ballinger, MD (PRINCIPAL_INVESTIGATOR) |
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