← 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

DOSI Trial 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.Check my eligibility

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.See study design

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.

DOSI Trial 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.

DOSI Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Biopsy

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

DOSI Trial Design

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.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Medical CenterLead Sponsor

385 Previous Clinical Trials

873,523 Total Patients Enrolled

4 Trials studying Breast Cancer

8,083 Patients Enrolled for Breast Cancer

American Cancer Society, Inc.OTHER

224 Previous Clinical Trials

110,408 Total Patients Enrolled

32 Trials studying Breast Cancer

8,837 Patients Enrolled for Breast Cancer

Naomi Ko, MD MPHPrincipal InvestigatorBoston Medical Center

Media Library

Diffuse Optical Spectroscopy Imaging (DOSI) (Imaging Technology) Clinical Trial Eligibility Overview. Trial Name: NCT02510456 — N/A

Breast Cancer Research Study Groups: Diffuse Optical Spectroscopy Imaging - Non-NAC Cohort, Diffuse Optical Spectroscopy Imaging - Neoadjuvant Chemo (NAC) Cohort

Breast Cancer Clinical Trial 2023: Diffuse Optical Spectroscopy Imaging (DOSI) Highlights & Side Effects. Trial Name: NCT02510456 — N/A

Diffuse Optical Spectroscopy Imaging (DOSI) (Imaging Technology) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02510456 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there presently opportunities for enrolment in this clinical trial?

"This specific treatment trial is no longer accepting patients. Initially posted on January 1st 2015, it was last updated on September 20th 2022. However, there are still more than 2600 active clinical studies that may be seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2015. "Monitoring Neoadjuvant Chemotherapy Response in Breast Cancer Patients Using Diffuse Optical Spectroscopic Imaging". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02510456.