Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06744465

NearWave Optical Molecular Monitoring

Led by Indiana University · Updated on 2026-02-17

15

Participants Needed

1

Research Sites

95 weeks

Total Duration

On this page

Sponsors

I

Indiana University

Lead Sponsor

U

University of Notre Dame

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

NearWave Optical Molecular Monitoring

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women 18 years or older at the time of consent
  • Ability to provide written informed consent and HIPAA authorization
  • Diagnosed with invasive breast cancer by tissue biopsy and not started any therapy
  • Breast cancer subtype HER2 positive (IHC 3+ or IHC 2+ with positive FISH), any ER status, or triple-negative breast cancer (HER2 negative and ER/PR negative or low)
  • Tumor size 2 cm or larger in the largest dimension by imaging (ultrasound, MRI, or mammography); if multifocal, at least one tumor 2 cm or larger
  • Planned to receive neoadjuvant chemotherapy followed by surgery
  • At least two weeks post biopsy of the primary lesion at baseline visit
  • Palpable breast mass as determined by a physician
Not Eligible

You will not qualify if you...

  • Significant bruising or hematoma from breast biopsy (mild ecchymosis allowed)
  • Inflammatory breast cancer
  • Prior breast cancer surgery or radiation in either breast
  • Pregnant or nursing
  • Body mass index (BMI) 40 or higher unless the lesion is within 3 cm of the skin surface
  • Any tattoos on the breasts

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Indiana University Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States, 46202

Actively Recruiting

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Research Team

T

Tarah J Ballinger, MD

CONTACT

X

Xin Bryan, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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