Monitoring breast cancer treatment with NearWave technology
NearWave Optical Molecular Monitoring for Predicting Complete Pathological Response (pCR) to Neoadjuvant Chemotherapy (NAC) in Breast Cancer Patients
This study is testing a new imaging device called NearWave to see if it can help track how well breast cancer treatment is working for patients getting chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Indiana University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT06744465 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the feasibility of the NearWave optical molecular monitoring system in tracking therapy progression and predicting pathologic complete response (pCR) in breast cancer patients undergoing neoadjuvant chemotherapy. It is a prospective, observational study where imaging data will be collected to assess the quality of information provided by the NearWave device. The study will not use the imaging data to inform treatment decisions but will focus on establishing whether the data quality is sufficient for further investigation.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older with invasive breast cancer who have not yet started therapy and meet specific tumor size and subtype criteria.
Not a fit: Patients with significant bruising or hematoma from diagnostic procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the ability to monitor treatment effectiveness in breast cancer patients, potentially leading to better outcomes.
How similar studies have performed: While this approach is novel and has not been extensively tested, similar imaging technologies have shown promise in other cancer types.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Indianapolis, Indiana
- Indiana University Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Study coordinator: Tarah J Ballinger, MD
- Email: tarahb@iu.edu
- Phone: (317) 944-3553
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.