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

NCT02510456 | Completed FDA Device

• 3 other identifiers: H-33188RSG-14-015-01-CCEDOSI
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Diffuse Optical Spectroscopy Imaging (DOSI)

Outcome Measures

Primary Outcomes (1)

• Analysis of differences in longitudinal trends of oxyhemoglobin concentration as related to final pathological response

  The longitudinal trends of oxyhemoglobin concentration measured over the early time-points (infusion, first 10 days). Differences in these trends will be analyzed to determine if they are prognostic of the final pathologic response (i.e. pathological complete response or non-complete response) of the primary tumor in patients with locally advanced breast cancer.

  6 months

Secondary Outcomes (2)

• Analysis of longitudinal trends of other composite DOSI derived parameters (deoxyhemoglobin, total blood volume, oxygen saturation, water, lips concentrations)

  6 months

• Analysis of composite DOSI derived parameters (deoxyhemoglobin, total blood volume, oxygen saturation, water, lips concentrations) as related to overall pathologic response and to biopsy results

  up to 6 months

Study Arms (2)

Diffuse Optical Spectroscopy Imaging - Neoadjuvant Chemo (NAC) Cohort

Diffuse Optical Spectroscopy Imaging (DOSI) at 6 time points.

Device: Diffuse Optical Spectroscopy Imaging (DOSI) - Neoadjuvant Chemo (NAC) Cohort

Diffuse Optical Spectroscopy Imaging - Non-NAC Cohort

Diffuse Optical Spectroscopy Imaging (DOSI) at 1 time point.

Device: Diffuse Optical Spectroscopy Imaging (DOSI) - Non-NAC Cohort

Interventions

Diffuse Optical Spectroscopy Imaging (DOSI) - Neoadjuvant Chemo (NAC) Cohort DEVICE

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.

Diffuse Optical Spectroscopy Imaging - Neoadjuvant Chemo (NAC) Cohort

Diffuse Optical Spectroscopy Imaging (DOSI) - Non-NAC Cohort DEVICE

Participants will have 1 DOSI scan at baseline. The DOSI scan will take about 30-60 minutes.

Diffuse Optical Spectroscopy Imaging - Non-NAC Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The first cohort will consist of participants with up to 9 DOSI scans at 6 different time points during the course of their neoadjuvant chemotherapy (NAC). The time course of chemotherapy may vary between 3-9 months depending on the type chemotherapy subjects receive. There will be a second cohort of patients with breast cancer who are not receiving neoadjuvant chemotherapy (NAC) and who will only be measured at baseline.

You may qualify if:

• Female;
• Diagnosis of invasive breast cancer by clinical breast examination, by standard of care diagnostic imaging, or by initial tissue biopsy;
• Planned for primary systemic (neoadjuvant) chemotherapy and surgical resection of residual primary tumor following completion of neoadjuvant chemotherapy;
• Tumor size ≥ 2cm, measured on imaging or estimated by physical exam;
• Planned definitive breast surgery (mastectomy or lumpectomy/breast conservation) following completion of neoadjuvant therapy;
• Age 18 years or older;
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 (Karnofsky performance status ≥ 60%;
• Adequate organ and marrow function, as defined at Boston Medical Center (BMC);
• Postmenopausal for a minimum of one year, OR surgically sterile, OR not pregnant, confirmed by a pregnancy test as per institutional standard of care, and willing to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation;
• Able to understand and willing to sign a written informed consent document and a Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines.
• Female;
• Diagnosis of invasive breast cancer by clinical breast examination, by standard of care diagnostic imaging, or by initial tissue biopsy;
• Tumor size ≥2cm, measured on imaging or estimated by physical exam;
• Planned definitive breast surgery (mastectomy or lumpectomy/breast conservation) following completion of neoadjuvant therapy;
• Age 18 years or older;

You may not qualify if:

• Previous treatment (chemotherapy, radiation, or surgery) to involved breast;
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;
• Medically unstable;
• Under age 18;
• Pregnant or nursing;
• Previous malignancy, other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix, from which the patient has been disease free for less than 5 years;
• No contraindications for primary chemotherapy.

Sponsors & Collaborators

• Boston Medical Center: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cohort Studies

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Naomi Ko, MD MPH

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: July 29, 2015
• Study Start: January 1, 2015
• Primary Completion: May 8, 2025
• Study Completion: May 8, 2025
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)