NCT06744465Active, not recruiting
NearWave Optical Molecular Monitoring
NearWave Optical Molecular Monitoring for Predicting Complete Pathological Response (pCR) to Neoadjuvant Chemotherapy (NAC) in Breast Cancer Patients
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 5 (actual)
- First submitted
- 17 Dec 2024
- Start date
- 7 Mar 2025
- Primary completion date
- Jan 2027
- Lead sponsor
- Indiana University
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT06744465
What you commit to
- Study type: Interventional
- Participants enrolled: 5
- From 7 Mar 2025 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior breast cancer requiring surgery or radiation in either breast
Other illness
- Inflammatory breast cancer
Other
- Patients with significant bruising or hematoma from diagnostic breast biopsy, as determined by clinical judgement (mild ecchymosis okay)
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Indiana University Simon Comprehensive Cancer Center Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.