NCT06744465

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
8mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Mar 2025Jan 2027

First Submitted

Initial submission to the registry

December 17, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

March 7, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

1.8 years

First QC Date

December 17, 2024

Last Update Submit

February 12, 2026

Conditions

Breast CancerHER2-positive Breast CancerTNBC - Triple-Negative Breast CancerHER2-negative Breast CancerInvasive Breast Carcinoma

Keywords

neoadjuvant chemotherapybreast cancerimagingNearWaveinvasive breast cancer

Outcome Measures

Primary Outcomes (3)

  • Feasibility of using NearWave imaging as a monitoring system

    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;

    Over approximately 5 months; baseline, mid way through treatment, and at last dose of clinical chemotherapy/prior to clinical surgery

  • Feasibility of using NearWave imaging as a monitoring system

    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

    Over approximately 5 months; baseline, mid way through treatment, and at last dose of clinical chemotherapy/prior to clinical surgery

  • Feasibility of using NearWave imaging as a monitoring system

    Adequate data quality metrics: • Estimated tissue concentrations of HHb, HbO2, water, and lipid within expected physiological ranges.

    Over approximately 5 months; baseline, mid way through treatment, and at last dose of clinical chemotherapy/prior to clinical surgery

Study Arms (1)

NearWave monitoring

EXPERIMENTAL

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

Device: NearWave monitoring

Interventions

NearWave monitoringDEVICE

NearWave optical molecular monitoring

NearWave monitoring

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsTriple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Tarah J Ballinger, MD

CONTACT

(317) 944-3553tarahb@iu.edu

Xin Bryan, RN

CONTACT

317-312-2793zhongx@iu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Medicine

Study Record Dates

First Submitted

December 17, 2024

First Posted

December 20, 2024

Study Start

March 7, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

February 17, 2026

Record last verified: 2026-02

Locations

US(1)