Clinical trial NCT06744465: NearWave Optical Molecular Monitoring
Official title: NearWave Optical Molecular Monitoring for Predicting Complete Pathological Response (pCR) to Neoadjuvant Chemotherapy (NAC) in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
HER2-positive Breast Cancer
TNBC - Triple-Negative Breast Cancer
HER2-negative Breast Cancer
Invasive Breast Carcinoma
Keywords: neoadjuvant chemotherapy
breast cancer
imaging
NearWave
invasive breast cancer
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: University of Notre Dame
name: Elevate Ventures
name: NearWave Corp.
First posted: 2024-12-20
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Feasibility of using NearWave imaging as a monitoring system
timeFrame: Over approximately 5 months; baseline, mid way through treatment, and at last dose of clinical chemotherapy/prior to clinical surgery
measure: Feasibility of using NearWave imaging as a monitoring system
timeFrame: Over approximately 5 months; baseline, mid way through treatment, and at last dose of clinical chemotherapy/prior to clinical surgery
measure: Feasibility of using NearWave imaging as a monitoring system
timeFrame: Over approximately 5 months; baseline, mid way through treatment, and at last dose of clinical chemotherapy/prior to clinical surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Simon Comprehensive Cancer Center
state: Indiana
Study officials:
References: