DOSI Monitoring for Chemotherapy Response in Breast Cancer
(DOSI Trial)

Recruiting in Palo Alto (17 mi)

Overseen byNaomi Ko, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Boston Medical Center

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study seeks to enroll women with breast cancer undergoing neoadjuvant chemotherapy to evaluate the efficacy of an investigational imaging technology known as Diffuse Optical Spectroscopy Imaging (DOSI) in predicting 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.

Research Team

Naomi Ko, MD

Principal Investigator

Boston Medical Center

Eligibility Criteria

This trial is for women over 18 with invasive breast cancer who are postmenopausal, surgically sterile, or using contraception. They must be planning to have surgery after neoadjuvant chemotherapy and have a tumor size of at least 2cm. Participants should not be pregnant, nursing, or have had certain other cancers within the last five years.

Inclusion Criteria

I am a woman diagnosed with invasive breast cancer.

My tumor is at least 2cm big.

I am scheduled for breast surgery after initial treatment.

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Exclusion Criteria

I am medically stable.

I have been cancer-free for less than 5 years, except for certain skin cancers or cervical cancer.

I can safely receive initial chemotherapy.

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Treatment Details

Interventions

Diffuse Optical Spectroscopy Imaging (DOSI) (Imaging Technology)

Trial OverviewThe study tests Diffuse Optical Spectroscopy Imaging (DOSI), a noninvasive method that uses near-infrared light to monitor how breast tumors respond to chemotherapy without harmful radiation or contrast agents. It's designed for frequent use in outpatient settings like doctor's offices.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Diffuse Optical Spectroscopy Imaging - Non-NAC CohortExperimental Treatment1 Intervention

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

Group II: Diffuse Optical Spectroscopy Imaging - Neoadjuvant Chemo (NAC) CohortExperimental Treatment1 Intervention

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