← Back to Search

Imaging Technology

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

N/A

Waitlist Available

Led By Naomi Ko, MD MPH

Research Sponsored by Boston Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female with diagnosis of invasive breast cancer confirmed by clinical breast examination, diagnostic imaging, or initial tissue biopsy

Tumor size ≥ 2cm, measured on imaging or estimated by physical exam

Must not have

Medically unstable

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether an investigational imaging technology called DOSI can predict how well breast cancer patients will respond to chemotherapy treatment. DOSI is a noninvasive imaging method that uses harmless near-infrared light and requires no external contrast agent.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Since DOSI involves nonionizing radiation and does not require external contrast agents or high light exposure, it is considered low-risk with minimal side effects related primarily to skin contact from wearable probes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman diagnosed with invasive breast cancer.

Select...

My tumor is at least 2cm big.

Select...

I am scheduled for breast surgery after initial treatment.

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

I am 18 years old or older.

Select...

I am scheduled for chemotherapy before surgery to remove my tumor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am medically stable.

Select...

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

Select...

I can safely receive initial chemotherapy.

Select...

I have had treatment (chemo, radiation, or surgery) on the breast with cancer.

Select...

I am under 18 years old.

Select...

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Biopsy

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