DOSI Monitoring for Chemotherapy Response in Breast Cancer
(DOSI Trial)
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 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline DOSI Scan
Participants undergo a baseline DOSI scan to establish initial tumor metabolic activity
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
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Diffuse Optical Spectroscopy Imaging (DOSI)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Medical Center
Lead Sponsor
American Cancer Society, Inc.
Collaborator