DOSI Monitoring for Chemotherapy Response in Breast Cancer

(DOSI Trial)

Overseen By Naomi Ko, MD MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Boston Medical Center

Disqualifiers: Previous treatment, Uncontrolled illness, Medically unstable, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

47 Participants Needed

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Diffuse Optical Spectroscopy Imaging (DOSI) for monitoring chemotherapy response in breast cancer?

Research shows that DOSI can effectively monitor changes in breast tumors during chemotherapy, such as reductions in tumor size and changes in blood and water content, which are indicators of treatment response. Studies found that DOSI measurements can predict how well a patient will respond to chemotherapy as early as one day after treatment starts, helping to adjust treatment plans for better outcomes. ^{1 2 3 4 5}

Is Diffuse Optical Spectroscopy Imaging (DOSI) safe for monitoring chemotherapy response in breast cancer?

The studies on Diffuse Optical Spectroscopy Imaging (DOSI) for monitoring chemotherapy response in breast cancer do not report any safety concerns, suggesting it is generally safe for use in humans. ^{1 2 3 6 7}

How does the treatment Diffuse Optical Spectroscopy Imaging (DOSI) differ from other treatments for breast cancer?

Diffuse Optical Spectroscopy Imaging (DOSI) is unique because it is a noninvasive method that uses light to measure changes in the breast tissue, allowing doctors to monitor how well a tumor is responding to chemotherapy in real-time. Unlike traditional imaging methods, DOSI can provide detailed information about the tumor's physiological changes, such as blood and water content, which can help predict treatment outcomes. ^{1 2 3 7 8}

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline DOSI Scan

Participants undergo a baseline DOSI scan to establish initial tumor metabolic activity

1 week

1 visit (in-person)

Neoadjuvant Chemotherapy with DOSI Monitoring

Participants receive neoadjuvant chemotherapy with DOSI scans at multiple time points including during drug infusion, early therapy, mid-therapy, and post-therapy

6 months

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Diffuse Optical Spectroscopy Imaging (DOSI)

Trial Overview 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.

Participant Groups

Group I: Diffuse Optical Spectroscopy Imaging - Non-NAC Cohort Experimental Treatment 1 Intervention

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

Group II: Diffuse Optical Spectroscopy Imaging - Neoadjuvant Chemo (NAC) Cohort Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Optical mammography using diffuse optical spectroscopy for monitoring tumor response to neoadjuvant chemotherapy in women with locally advanced breast cancer. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Combined diffuse optical spectroscopy and contrast-enhanced magnetic resonance imaging for monitoring breast cancer neoadjuvant chemotherapy: a case study. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Monitoring neoadjuvant chemotherapy in breast cancer using quantitative diffuse optical spectroscopy: a case study. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Optical imaging of breast cancer oxyhemoglobin flare correlates with neoadjuvant chemotherapy response one day after starting treatment. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Tissue oxygen saturation predicts response to breast cancer neoadjuvant chemotherapy within 10 days of treatment. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Diffuse optical monitoring of blood flow and oxygenation in human breast cancer during early stages of neoadjuvant chemotherapy. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Predicting Responses to Neoadjuvant Chemotherapy in Breast Cancer: ACRIN 6691 Trial of Diffuse Optical Spectroscopic Imaging. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Predicting breast cancer response to neoadjuvant chemotherapy using pretreatment diffuse optical spectroscopic texture analysis. [2019]