NCT06744465

NearWave Optical Molecular Monitoring

NearWave Optical Molecular Monitoring for Predicting Complete Pathological Response (pCR) to Neoadjuvant Chemotherapy (NAC) in Breast Cancer Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a prospective, observational, pilot study. Due to the investigational nature of the NearWave device, imaging data collected will not be used to inform patient treatment. Since this is our first experience with the NearWave device and there does not exist any preliminary data with this device, we are performing this pilot study to establish whether data collected is of high enough quality to warrant further study. Primary Objective: The primary objective of this study is to assess the feasibility of using the NearWave optical molecular monitoring system during therapy to predict pCR in breast cancer patients undergoing NAC, measured by the data quality captured with the device.

Conditions

• Breast Cancer
• HER2-positive Breast Cancer
• TNBC - Triple-Negative Breast Cancer
• HER2-negative Breast Cancer
• Invasive Breast Carcinoma

Interventions

Type	Name	Description
DEVICE	NearWave monitoring	NearWave optical molecular monitoring

Timeline

• Start date: 2025-03-07
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2024-12-20
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study