NearWave Optical Molecular Monitoring
Recruiting now · Not applicable
Conditions studied: Breast Cancer, HER2-positive Breast Cancer, TNBC - Triple-Negative Breast Cancer, HER2-negative Breast Cancer, Invasive Breast Carcinoma
In brief
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).
Key facts
- Study ID
- NCT06744465
- Run by
- Indiana University
- People needed
- 15
- Starts
- 2025-03-07
- Expected to finish
- 2027-01-01
- Last updated by the study team
- 2026-02-17
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
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
Where it is running
- Indiana University Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.