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New treatment option for Breast Cancer
Official title NearWave Optical Molecular Monitoring
ClinicalTrials.gov ID: NCT06744465
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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...
- 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...
You likely can't join 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
See the full eligibility criteria
- 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)...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.