NearWave Optical Molecular Monitoring
NearWave Optical Molecular Monitoring for Predicting Complete Pathological Response (pCR) to Neoadjuvant Chemotherapy (NAC) in Breast Cancer Patients
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether the NearWave light-based system can track how breast cancer responds to chemotherapy given before surgery. It also tests whether the system can predict if no cancer remains in tissue checked after treatment. It is for adult women with certain types of breast cancer who plan to have chemotherapy followed by surgery.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Women age 18 or older when they agree to join.
- Able to give written consent and permission to use and share health information.
- Breast cancer confirmed by a tissue sample, with cancer that has grown into nearby breast tissue. No treatment for this cancer has started.
- Cancer must be HER2-positive by testing, with any estrogen receptor status; or HER2-negative with estrogen and progesterone receptors both negative or low (9% or less, with weak staining). These tests measure proteins that can help cancer grow.
- At least one breast tumor measures 2 cm or more across on ultrasound, MRI, or mammogram.
- Plan to have chemotherapy before surgery.
- The first study visit will be at least two weeks after the main breast tumor biopsy.
- A treating doctor can feel the breast lump.
Who can't join
- Major bruising or a collection of blood from the breast biopsy, as judged by the care team. Mild bruising is allowed.
- Inflammatory breast cancer.
- Past breast cancer that required surgery or radiation in either breast.
- Pregnant or breastfeeding.
- Body mass index (BMI), a measure based on height and weight, of 40 or higher, unless scans show the tumor is less than 3 cm below the skin.
- Any tattoos on the breasts.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
IN
- Indiana University Simon Comprehensive Cancer Center · Indianapolis, IN 46202Tarah J Ballinger, MD · Study contact · 3172742556 · tarahb@iu.eduXin Bryan, RN · Study contact · 317-312-2793 · zhongx@iu.eduTarah J Ballinger, MD · Principal investigatorMore trials in Indianapolis