NearWave Optical Molecular Monitoring

NCT ID: NCT06744465

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-07
• Study Completion Date: 2026-01-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

NearWave monitoring

Breast cancer patients receiving neoadjuvant chemotherapy treatment followed by surgery will be monitored by a noninvasive handheld imaging device before, during and after chemotherapy.

Group Type: EXPERIMENTAL

NearWave monitoring

Intervention Type: DEVICE

NearWave optical molecular monitoring

Interventions

NearWave monitoring

NearWave optical molecular monitoring

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Notre Dame

OTHER

Sponsor Role: collaborator

Elevate Ventures

UNKNOWN

Sponsor Role: collaborator

NearWave Corp.

UNKNOWN

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Tarah J Ballinger, MD

Assistant Professor of Clinical Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Indiana University Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tarah J Ballinger, MD

Role: CONTACT

tarahb@iu.edu

(317) 944-3553

Xin Bryan, RN

Role: CONTACT

zhongx@iu.edu

317-312-2793

Facility Contacts

Tarah J Ballinger, MD

Role: primary

tarahb@iu.edu

3172742556

Xin Bryan, RN

Role: backup

zhongx@iu.edu

317-312-2793

Other Identifiers

CTO-IUSCCC-0880

Identifier Type: -

Identifier Source: org_study_id