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| ID | Type | Description | Link |
|---|---|---|---|
| RSG-14-015-01-CCE | Other Grant/Funding Number | American Cancer Society | |
| DOSI | Other Identifier | Boston Medical Center |
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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
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This study seeks to enroll women with breast cancer undergoing neoadjuvant chemotherapy to evaluate if Diffuse Optical Spectroscopy Imaging (DOSI) can predict a 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.
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 30-60 minutes/ 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.
A cohort of 10 additional patients with breast cancer who are not receiving neoadjuvant chemotherapy (NAC) who will only be measured at baseline has been created. Complete characterization of baseline properties in patients is essential for understanding subsequent changes from baseline in response to chemotherapy. Adding an additional 10 patients who are not receiving NAC to be enrolled will allow for better characterization of baseline properties, which in turn will allow for a better understanding of the changes in properties seen in those patients who are undergoing NAC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diffuse Optical Spectroscopy Imaging - Neoadjuvant Chemo (NAC) Cohort | Diffuse Optical Spectroscopy Imaging (DOSI) at 6 time points. |
| |
| Diffuse Optical Spectroscopy Imaging - Non-NAC Cohort | Diffuse Optical Spectroscopy Imaging (DOSI) at 1 time point. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diffuse Optical Spectroscopy Imaging (DOSI) - Neoadjuvant Chemo (NAC) Cohort | Device | Participants will have up to 9 DOSI scans at 6 different time points during the course of their neoadjuvant chemotherapy. The time course of chemotherapy may vary between 3-9 months depending on the type chemotherapy subjects receive. Depending on chemotherapy schedule, subjects may or may not be asked to participate in all the 6 measurement time points. The number of DOSI scans each subject requires will be decided during consent. Each DOSI scan will take about 30-60 minutes, although scans at infusion time point will take longer in total due to repeated or continuous measurements. |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of differences in longitudinal trends of oxyhemoglobin concentration as related to final pathological response | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of longitudinal trends of other composite DOSI derived parameters (deoxyhemoglobin, total blood volume, oxygen saturation, water, lips concentrations) | 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. |
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Inclusion Criteria for Neoadjuvant Chemo (NAC) Cohort:
Inclusion Criteria for Non-NAC Cohort:
Exclusion Criteria for All Cohorts:
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The first cohort will consist of participants with up to 9 DOSI scans at 6 different time points during the course of their neoadjuvant chemotherapy (NAC). The time course of chemotherapy may vary between 3-9 months depending on the type chemotherapy subjects receive.
There will be a second cohort of patients with breast cancer who are not receiving neoadjuvant chemotherapy (NAC) and who will only be measured at baseline.
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| Name | Affiliation | Role |
|---|---|---|
| Naomi Ko, MD MPH | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 2, 2022 | Jun 3, 2025 |
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| Diffuse Optical Spectroscopy Imaging (DOSI) - Non-NAC Cohort | Device | Participants will have 1 DOSI scan at baseline. The DOSI scan will take about 30-60 minutes. |
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| 6 months |
| 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 | 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. | up to 6 months |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D015331 | Cohort Studies |
| ID | Term |
|---|---|
| D016021 | Epidemiologic Studies |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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