NearWave Optical Molecular Monitoring

Not Applicable

Recruiting

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

• Registration Number: NCT06744465
• Lead Sponsor: Indiana University

Brief 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.

Study Timeline

• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-17
• Study First Posted: 2024-12-20
• Study Start: 2025-03-07
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

1. Women ≥ 18 years old at the time of informed consent

2. Ability to provide written informed consent and HIPAA authorization

3. Patients who:

   1. have been diagnosed with invasive breast cancer by tissue biopsy and have not yet started any therapy for the disease; a) Subtype HER2 positive (IHC 3+ or if IHC 2+, then positive by FISH), with any ER status, OR b) Subtype TNBC, defined by: HER2 negative and ER/PR negative or low (ER and PR ≤ 9%, weak staining)
   2. with ≥2 cm tumor size in the largest dimension as measured by ultrasound, MRI, or mammography. If multifocal disease, at least one tumor must measure ≥2 cm
   3. are planned to receive neoadjuvant chemotherapy followed by surgery
   4. Will be at least two weeks out from biopsy of the primary lesion at the time of baseline visit
   5. Have a palpable breast mass as determined by a treating physician

Exclusion Criteria

1. Patients with significant bruising or hematoma from diagnostic breast biopsy, as determined by clinical judgement (mild ecchymosis okay)
2. Inflammatory breast cancer
3. Prior breast cancer requiring surgery or radiation in either breast
4. Pregnant or nursing due to changes in breast architecture
5. Patients with a BMI of ≥ 40, unless the lesion is near the surface (<3 cm from the skin surface), based on diagnostic scan measurements
6. Patients with any tattoos on their breasts

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of using NearWave imaging as a monitoring system	Over approximately 5 months; baseline, mid way through treatment, and at last dose of clinical chemotherapy/prior to clinical surgery	Adequate data quality metrics: • Estimated tissue concentrations of HHb, HbO2, water, and lipid within expected physiological ranges.

Trial Locations

Locations (1)

Indiana University Simon Comprehensive Cancer Center; 🇺🇸 Indianapolis, Indiana, United States