NCT02510456

Monitoring Neoadjuvant Chemotherapy Response in Breast Cancer Patients Using Diffuse Optical Spectroscopic Imaging

Monitoring Neoadjuvant Chemotherapy Response In Breast Cancer Patients Using Diffuse Optical Spectroscopic Imaging (DOSI)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study seeks to enroll women with breast cancer undergoing neoadjuvant chemotherapy to evaluate if Diffuse Optical Spectroscopy Imaging (DOSI) can predict a patient response to chemotherapy treatment. DOSI is a noninvasive imaging method that uses harmless near-infrared light using simple wearable probes held against the skin by transparent dressings to predict tumor metabolic activity. It uses nonionizing radiation, requires no external contrast agent and uses low light exposure to human tissue. DOSI scans can be performed frequently at the bedside in settings such as a doctor's office or infusion center.

Detailed description

DOSI has already shown promise in monitoring breast cancer patients undergoing preoperative chemotherapy. Several groups have demonstrated optical changes predictive of response in the course of weeks to months of treatment. The investigators group has begun to show that DOSI measurements during drug infusions and at early time-points (first 24 hours) correlate with tumor final pathological response. While this data is provocative, significantly more work is needed to confirm that early time-points are predictive in different treatment groups and tumor molecular subtypes. In this study, breast cancer patients will receive DOSI scans at a subset or all of the following time-points: baseline, during drug infusion, early therapy, mid-therapy and post-therapy. DOSI results will be compared to standard of care pathology results determined after surgery. Additionally, the investigators will correlate DOSI parameters with any additional biopsy specimens taken during treatment (typically for patients on adaptive treatment trials). Each DOSI scan will take about 30-60 minutes/ session, although infusion measurements will take longer. DOSI can potentially help doctors to gain information necessary to make evidence-based changes in treatment strategies of individual patients. The investigators long-term goal is to provide oncologists with a relatively simple, risk-free bedside tool that can help predict response early, thereby maximizing therapeutic response and minimizing unnecessary toxicity. A cohort of 10 additional patients with breast cancer who are not receiving neoadjuvant chemotherapy (NAC) who will only be measured at baseline has been created. Complete characterization of baseline properties in patients is essential for understanding subsequent changes from baseline in response to chemotherapy. Adding an additional 10 patients who are not receiving NAC to be enrolled will allow for better characterization of baseline properties, which in turn will allow for a better understanding of the changes in properties seen in those patients who are undergoing NAC.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Diffuse Optical Spectroscopy Imaging (DOSI) - Neoadjuvant Chemo (NAC) Cohort	Participants will have up to 9 DOSI scans at 6 different time points during the course of their neoadjuvant chemotherapy. The time course of chemotherapy may vary between 3-9 months depending on the type chemotherapy subjects receive. Depending on chemotherapy schedule, subjects may or may not be asked to participate in all the 6 measurement time points. The number of DOSI scans each subject requires will be decided during consent. Each DOSI scan will take about 30-60 minutes, although scans at infusion time point will take longer in total due to repeated or continuous measurements.
DEVICE	Diffuse Optical Spectroscopy Imaging (DOSI) - Non-NAC Cohort	Participants will have 1 DOSI scan at baseline. The DOSI scan will take about 30-60 minutes.

Timeline

• Start date: 2015-01-01
• Primary completion: 2025-05-08
• Completion: 2025-05-08
• First posted: 2015-07-29
• Last updated: 2025-10-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study