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NCT Number: NCT06744465

NearWave Optical Molecular Monitoring

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).

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms HER2-negative Breast Cancer HER2-positive Breast Cancer Invasive Breast Carcinoma Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases TNBC - Triple-Negative Breast Cancer Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

Location status: Recruiting

Location contact

Tarah J Ballinger, MD

CONTACT

[email protected]

3172742556

Tarah J Ballinger, MD

PRINCIPAL_INVESTIGATOR

Xin Bryan, RN

CONTACT

[email protected]

317-312-2793

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women ≥ 18 years old at the time of informed consent
  • Ability to provide written informed consent and HIPAA authorization
  • Patients who:
  • 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)
  • 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
  • are planned to receive neoadjuvant chemotherapy followed by surgery
  • Will be at least two weeks out from biopsy of the primary lesion at the time of baseline visit
  • Have a palpable breast mass as determined by a treating physician

Exclusion criteria

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

Treatment and study plan

NearWave monitoring

Device

NearWave optical molecular monitoring

Primary outcomes

  1. 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

    Adequate data quality metrics:

    Signal-to-noise ratio (SNR) (measurement that compares the strength of a signal to the level of background noise) above 10 dB for at least 80% of collected data points;

  2. 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

    Adequate data quality metrics:

    • Model fit metric: Root mean squared error (RMSE) ( the average difference between the predicted values and the actual values) of 5x10-4 or lower for regressions of calibrated imaging

  3. 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

    Adequate data quality metrics:

    • Estimated tissue concentrations of HHb, HbO2, water, and lipid within expected physiological ranges.

Study contacts

Contact information is provided by the study sponsor or research team.

Tarah J Ballinger, MD

CONTACT

[email protected]

(317) 944-3553

Xin Bryan, RN

CONTACT

[email protected]

317-312-2793

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Elevate Ventures
  • NearWave Corp.
  • University of Notre Dame

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 20, 2024
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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