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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02510456
Recruitment Status : Suspended (Currently no recruitment or study interventions due to COVID-19 policies)
First Posted : July 29, 2015
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Diffuse Optical Spectroscopy Imaging (DOSI) Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Monitoring Neoadjuvant Chemotherapy Response In Breast Cancer Patients Using Diffuse Optical Spectroscopic Imaging (DOSI)
Actual Study Start Date : January 2015
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diffuse Optical Spectroscopy Imaging
Diffuse Optical Spectroscopy Imaging (DOSI)
Device: Diffuse Optical Spectroscopy Imaging (DOSI)
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 timepoint will take longer in total due to repeated or continuous measurements.




Primary Outcome Measures :
  1. Analysis of differences in longitudinal trends of oxyhemoglobin concentration as related to final pathological response [ Time Frame: 6 months ]
    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 complete response or non-complete response) of the primary tumor in patients with locally advanced breast cancer.


Secondary Outcome Measures :
  1. Analysis of longitudinal trends of other composite DOSI derived parameters (deoxyhemoglobin, total blood volume, oxygen saturation, water, lips concentrations) [ Time Frame: 6 months ]
    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.

  2. 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 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02510456


Locations
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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
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Principal Investigator: Naomi Ko, MD MPH Boston Medical Center
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Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT02510456    
Other Study ID Numbers: H-33188
RSG-14-015-01-CCE ( Other Grant/Funding Number: American Cancer Society )
DOSI ( Other Identifier: Boston Medical Center )
First Posted: July 29, 2015    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases