NearWave Optical Molecular Monitoring

Launched by INDIANA UNIVERSITY · Dec 17, 2024

Keywords

ClinConnect Summary

The NearWave Optical Molecular Monitoring trial is studying a new system to help doctors track how well breast cancer patients are responding to treatment. Specifically, it aims to see if this technology can predict whether patients will have a complete response to their chemotherapy before surgery. The trial is currently looking for women over the age of 18 who have been diagnosed with certain types of invasive breast cancer and have not yet started any treatment. To qualify, participants should have a tumor that is at least 2 centimeters in size and be planning to receive chemotherapy followed by surgery.

If you decide to participate, you can expect to undergo some monitoring with the NearWave system during your treatment. This study is important because it may help improve how doctors understand and manage breast cancer treatment in the future. However, certain factors, like having a history of breast cancer surgery or significant bruising from a recent biopsy, might prevent you from being eligible. Overall, this trial aims to improve care for women with breast cancer by providing better ways to monitor treatment progress.

Gender

FEMALE

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