DOSI Monitoring for Chemotherapy Response in Breast Cancer

(DOSI Trial)

AJ
NK
Overseen ByNaomi Ko, MD MPH
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Boston Medical Center
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new imaging method, Diffuse Optical Spectroscopy Imaging (DOSI), can predict breast cancer patients' responses to chemotherapy. DOSI uses harmless near-infrared light to assess tumor activity and can be performed easily at a doctor’s office. Women with breast cancer planning to undergo chemotherapy and surgery might be suitable candidates, particularly if their tumor is 2 cm or larger. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in breast cancer care.

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 prior data suggests that Diffuse Optical Spectroscopy Imaging (DOSI) is safe for monitoring chemotherapy response in breast cancer?

Research has shown that Diffuse Optical Spectroscopy Imaging (DOSI) is very safe for people. Early results suggest that DOSI, which uses harmless near-infrared light, causes no harm. This method involves low light exposure and requires no additional chemicals, making it gentle on the body. Studies, including one focused on using DOSI for breast cancer, reported no safety concerns, indicating that patients handle the imaging process well. DOSI is designed to be simple and safe, allowing for frequent scans without risk to patients.12345

Why are researchers excited about this trial?

Researchers are excited about Diffuse Optical Spectroscopy Imaging (DOSI) for breast cancer because it offers a non-invasive way to monitor how well chemotherapy is working. Unlike traditional imaging techniques, DOSI measures changes in tissue composition, such as blood and oxygen levels, providing real-time insights into tumor response. This means it could help doctors adjust treatments more quickly and effectively, potentially improving outcomes for patients undergoing chemotherapy.

What evidence suggests that Diffuse Optical Spectroscopy Imaging (DOSI) is effective for predicting chemotherapy response in breast cancer?

Research has shown that Diffuse Optical Spectroscopy Imaging (DOSI) effectively tracks breast cancer tumors' responses to chemotherapy. In this trial, participants will be divided into two groups: one will undergo DOSI at a single time point, while the other will have DOSI at six different time points during neoadjuvant chemotherapy. Studies have found that DOSI provides clear images of a tumor's chemical makeup and monitors changes during treatment. This capability might help doctors determine early on if the chemotherapy is effective. DOSI uses safe, low-level light and doesn't require injections or radiation, making it easy and noninvasive. It has been successfully used to monitor tumor responses in women receiving chemotherapy before surgery.36789

Who Is on the Research Team?

Naomi Y. Ko, MD | Boston Medical Center

Naomi Ko, MD

Principal Investigator

Boston Medical Center

Are You a Good Fit for This Trial?

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.
See 5 more

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.
See 4 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Diffuse Optical Spectroscopy Imaging - Non-NAC CohortExperimental Treatment1 Intervention
Group II: Diffuse Optical Spectroscopy Imaging - Neoadjuvant Chemo (NAC) CohortExperimental Treatment1 Intervention

Find a Clinic Near You

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+

Citations

Diffuse optical spectroscopic imaging correlates with final ...This approach is well suited to monitoring breast tumour response and may provide feedback for optimizing therapeutic outcomes and minimizing side-effects.
Monitoring Neoadjuvant Chemotherapy Response in ...This study seeks to enroll women with breast cancer undergoing neoadjuvant chemotherapy to evaluate the efficacy of an investigational imaging technology ...
Predicting response to breast cancer neoadjuvant ...In early-stage clinical studies, diffuse optical imaging and DOS have been used to characterize breast tumor biochemical composition and monitor therapeutic ...
Optical Mammography Using Diffuse Optical Spectroscopy for ...This prospective study shows the successful use of optical imaging using diffuse optical spectroscopy (DOS) for tumor response monitoring during NAC in patients ...
Diffuse optical spectroscopic imaging reveals distinct early ...Diffuse optical spectroscopic imaging correlates with final pathological response in breast cancer neoadjuvant chemotherapy. Philos Trans R ...
Impact of clinical factors on the diagnostic performance ...This study investigates the impact of clinical factors on the diagnostic performance of diffuse optical spectroscopic imaging (DOSI) for detecting breast ...
Breast cancer differential diagnosis using diffuse optical ...Diffuse optical spectroscopic imaging (DOSI) noninvasively probes functional hemodynamic and compositional parameters in deep tissue and has been shown to be ...
DOSI Monitoring for Chemotherapy Response in Breast ...The studies on Diffuse Optical Spectroscopy Imaging (DOSI) for monitoring chemotherapy response in breast cancer do not report any safety concerns, suggesting ...
Application of optical spectroscopy in diagnosing and ...Optical imaging, and spectroscopy are known as real-time, sensitive, and non-invasive detecting approaches for human cancers in inaccessible locations.
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