Boston, Massachusetts 02118


Purpose:

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 a simple handheld probe held against the skin 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.


Study summary:

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 a simple handheld probe held against the skin 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. DOSI has already shown promise in monitoring breast cancer patients undergoing preoperative chemotherapy. Several groups have demonstrated optical changes predictive of response in the course of weeks to months of treatment. The investigators group has begun to show that DOSI measurements during drug infusions and at early time-points (first 24 hours) correlate with tumor final pathological response. While this data is provocative, significantly more work is needed to confirm that early time-points are predictive in different treatment groups and tumor molecular subtypes. In this study, breast cancer patients will receive DOSI scans at a subset or all of the following time-points: baseline, during drug infusion, early therapy, mid-therapy and post-therapy. DOSI results will be compared to standard of care pathology results determined after surgery. Additionally, the investigators will correlate DOSI parameters with any additional biopsy specimens taken during treatment (typically for patients on adaptive treatment trials). Each DOSI scan will take about 3045minutes/ session, although infusion measurements will take longer. DOSI can potentially help doctors to gain information necessary to make evidence-based changes in treatment strategies of individual patients. The investigators long-term goal is to provide oncologists with a relatively simple, risk-free bedside tool that can help predict response early, thereby maximizing therapeutic response and minimizing unnecessary toxicity.


Criteria:

Inclusion Criteria: 1. Female; 2. Diagnosis of invasive breast cancer by clinical breast examination, by standard of care diagnostic imaging, or by initial tissue biopsy; 3. Planned for primary systemic (neoadjuvant) chemotherapy and surgical resection of residual primary tumor following completion of neoadjuvant chemotherapy; 4. Tumor size ≥ 2cm, measured on imaging or estimated by physical exam; 5. Planned definitive breast surgery (mastectomy or lumpectomy/breast conservation) following completion of neoadjuvant therapy; 6. Age 18 years or older; 7. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 (Karnofsky performance status ≥ 60%; 8. Adequate organ and marrow function, as defined at Boston Medical Center; 9. Postmenopausal for a minimum of one year, OR surgically sterile, OR not pregnant, confirmed by a pregnancy test as per institutional standard of care, and willing to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation; 10. Able to understand and willing to sign a written informed consent document and a Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines. Exclusion Criteria: 1. Previous treatment (chemotherapy, radiation, or surgery) to involved breast; 2. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; 3. Medically unstable; 4. Under age 18; 5. Pregnant or nursing; 6. 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; 7. No contraindications for primary chemotherapy.


Study is Available At:


Original ID:

H-33188


NCT ID:

NCT02510456


Secondary ID:

RSG-14-015-01-CCE


Study Acronym:

DOSI


Brief Title:

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


Official Title:

Monitoring Neoadjuvant Chemotherapy Response In Breast Cancer Patients Using Diffuse Optical Spectroscopic Imaging (DOSI)


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Boston Medical Center


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

37


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Naomi Ko, MD
Principal Investigator
Boston Medical Center
Primary Contact:Sally Fennessey
617-638-8265
sally.fennessey@bmc.org

Study Dates

Start Date:January 2015
Completion Date:January 2022
Completion Type:Anticipated
Primary Completion Date:January 2021
Primary Completion Type:Anticipated
Verification Date:February 2019
Last Changed Date:February 6, 2019
First Received Date:March 9, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Analysis of composite DOSI derived parameters (deoxyhemoglobin, total blood volume, oxygen saturation, water, lips concentrations) as related to overall pathologic response and to biopsy results
Time Frame:up to 6 months
Safety Issues:False
Description:DOSI derived parameters (deoxyhemoglobin, total blood volume, oxygen saturation, water, lips concentrations) as measured immediately prior to a mid-therapy biopsy. These parameters will be correlated to overall pathologic response and to biopsy results.
Outcome Type:Secondary Outcome
Measure:Analysis of longitudinal trends of other composite DOSI derived parameters (deoxyhemoglobin, total blood volume, oxygen saturation, water, lips concentrations)
Time Frame:6 months
Safety Issues:False
Description:The longitudinal trends of other DOSI derived parameters (deoxyhemoglobin, total blood volume, oxygen saturation, water, lips concentrations) measured over the early time-points (infusion, first 10 days), mid therapy, and end therapy time-points.
Outcome Type:Primary Outcome
Measure:Analysis of differences in longitudinal trends of oxyhemoglobin concentration as related to final pathological response
Time Frame:6 months
Safety Issues:False
Description:The longitudinal trends of oxyhemoglobin concentration measured over the early time-points (infusion, first 10 days). Differences in these trends will be analyzed to determine if they are prognostic of the final pathologic response (i.e. pathological comp

Study Interventions

Intervention Type:Device
Name:Diffuse Optical Spectroscopy Imaging (DOSI)
Description:Subjects will have up to seven DOSI scans at 7 different time points during the course of their chemotherapy. The time course of chemotherapy may vary between 39 months depending on the type chemotherapy subjects receive. Depending on chemotherapy schedule, subjects may or may not be asked to participate in all the 7 measurement time points. The number of DOSI scans each subject requires will be decided during consent. Each DOSI scan will take about 30-45 minutes, although scans at infusion time
Arm Name:Diffuse Optical Spectroscopy Imaging

Study Arms

Study Arm Type:Experimental
Arm Name:Diffuse Optical Spectroscopy Imaging
Description:Diffuse Optical Spectroscopy Imaging (DOSI)

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Boston Medical Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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