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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA228047-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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Ultrasound-guided diffuse optical tomography (DOT) has demonstrated its potential role in differentiating malignant and benign breast abnormalities and in predicting and monitoring the neoadjuvant chemotherapy (NAC) response of breast cancer. This unique approach employs a commercial ultrasound (US) transducer and near infrared (NIR) optical imaging sensors mounted on a hand-held US probe. The co-registered US is used for lesion localization, and optical sensors are used for imaging tumor related vascularity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| US-DOT (US/NIR) Imaging | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hand-held hybrid probe | Device | Consists of a commercially available US transducer located in the middle and near-infrared source and detector optical fibers distributed at the periphery |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of US-guided DOT on the Potential Reduction of Benign Biopsies as Measured by Comparing the Reads With a Non- Suspicious Assessment of Conventional Imaging (CI) Alone Versus CI & US-DOT | -BI-RADS scores without and then with optical data will be rendered by study radiologists. Radiologists will be blinded to the biopsy exam and pathology outcomes. Optical data including total Hemoglobin concentration will be provided by the bioengineering team. Benign biopsy reduction will be calculated as the proportion of reads (CI & US-DOT subtract CI) with a non- suspicious assessment, i.e. BIRADS 2 'benign' or BIRADS 3 'probably benign', divided by the denominator of total reads with no cancer demonstrated at biopsy. US-guided core biopsy results and subsequent surgical pathology (if present) will be entered by the study pathologist. | Completion of enrollment for all patients (61 months), the imaging session took approximately 1 hour for the participating patient |
| Impact of US-guided DOT as an Adjunct to Conventional Breast Imaging on Maintaining High Sensitivity as Measured by Comparing the False Negative Rate or Missing Malignancy of Conventional Imaging (CI=US +/- Mammography) Alone Versus CI & US-DOT | -BI-RADS scores without and then with optical data will be rendered by study radiologists. Radiologists will be blinded to the biopsy exam and pathology outcomes. Optical data including total Hemoglobin concentration will be provided by the bioengineering team. The engineering team is also blinded to the biopsy exam and pathology outcomes. The False Negative Rate will be calculated as the proportion of reads with a non-suspicious assessment i.e. BIRADS 2 'benign' or BIRADS 3 'probably benign', who have cancer (defined as Invasive cancer or Ductal Carcinoma In Situ) demonstrated at biopsy divided by the denominator of all reads with cancer. US-guided core biopsy results and subsequent surgical pathology (if present) will be entered by the study pathologist. | Completion of enrollment for all patients (61 months), the imaging session took approximately 1 hour for the participating patient |
| Assess the Impact of Adjunctive US-guided DOT Data in the Management of Discordant Pathology Results | Completion of enrollment for all patients (61 months), the imaging session took approximately 1 hour for the participating patient |
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Inclusion Criteria:
Female subjects ≥ 18 years old with ultrasound visible breast abnormalities (BI-RADS 3*, 4A, 4B, 4C, and 5) referred for ultrasound-guided core needle biopsy or fine needle aspiration
*note that while a BI-RADS 3 assessment is probably benign, a subset of patients with this assessment choose to undergo biopsy rather than follow up imaging).
Willing and able to provide informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Debbie Bennett, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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The protocol states that there are two phases: phase I - training set and phase 2 - prospective trial. For the training set, the readers underwent an approximately 60-minute training session using a tool created from a pre-existing representative DOT findings in patients who had previously undergone US-guided DOT and who had a spectrum of documented benign and malignant pathology. Those patients were not consented or enrolled in this study and are not included in the presented data.
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| ID | Title | Description |
|---|---|---|
| FG000 | US-DOT (US/NIR) Imaging |
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
The protocol states that there are two phases: phase I - training set and phase 2 - prospective trial. For the training set, the readers underwent an approximately 60-minute training session using a tool created from a pre-existing representative DOT findings in patients who had previously undergone US-guided DOT and who had a spectrum of documented benign and malignant pathology. Those patients were not consented or enrolled in this study and are not included in the presented data.
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| ID | Title | Description |
|---|---|---|
| BG000 | US-DOT (US/NIR) Imaging |
|
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Impact of US-guided DOT on the Potential Reduction of Benign Biopsies as Measured by Comparing the Reads With a Non- Suspicious Assessment of Conventional Imaging (CI) Alone Versus CI & US-DOT | -BI-RADS scores without and then with optical data will be rendered by study radiologists. Radiologists will be blinded to the biopsy exam and pathology outcomes. Optical data including total Hemoglobin concentration will be provided by the bioengineering team. Benign biopsy reduction will be calculated as the proportion of reads (CI & US-DOT subtract CI) with a non- suspicious assessment, i.e. BIRADS 2 'benign' or BIRADS 3 'probably benign', divided by the denominator of total reads with no cancer demonstrated at biopsy. US-guided core biopsy results and subsequent surgical pathology (if present) will be entered by the study pathologist. | Posted | Count of Units | BIRADS assessments | Completion of enrollment for all patients (61 months), the imaging session took approximately 1 hour for the participating patient | BIRADS assessments | BIRADS assessments |
|
Serious adverse events that occurred within 24 hours of an NIR/US exam were collected. All-cause mortality was collected through 24 hours of the NIR/US exam.
The protocol states that there are two phases: phase I - training set & phase 2 - prospective trial. For the training set, the readers underwent a training session using a tool created from a pre-existing DOT findings in patients who had previously undergone US-guided DOT and who had a spectrum of documented benign and malignant pathology. Those patients were not consented or enrolled in this study and are not included in the data.
Non-serious adverse events were not collected for the patients.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | US-DOT (US/NIR) Imaging |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Debbie Bennett, M.D. | Washington University School of Medicine | 314-454-7696 | debbie.bennett@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2021 | Apr 22, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 13, 2024 | Feb 20, 2025 | ICF_000.pdf |
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| No biopsy after physician review |
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| Patient withdrew |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| US-DOT (US/NIR) Imaging |
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| Primary | Impact of US-guided DOT as an Adjunct to Conventional Breast Imaging on Maintaining High Sensitivity as Measured by Comparing the False Negative Rate or Missing Malignancy of Conventional Imaging (CI=US +/- Mammography) Alone Versus CI & US-DOT | -BI-RADS scores without and then with optical data will be rendered by study radiologists. Radiologists will be blinded to the biopsy exam and pathology outcomes. Optical data including total Hemoglobin concentration will be provided by the bioengineering team. The engineering team is also blinded to the biopsy exam and pathology outcomes. The False Negative Rate will be calculated as the proportion of reads with a non-suspicious assessment i.e. BIRADS 2 'benign' or BIRADS 3 'probably benign', who have cancer (defined as Invasive cancer or Ductal Carcinoma In Situ) demonstrated at biopsy divided by the denominator of all reads with cancer. US-guided core biopsy results and subsequent surgical pathology (if present) will be entered by the study pathologist. | Posted | Count of Units | BIRADS assessments | Completion of enrollment for all patients (61 months), the imaging session took approximately 1 hour for the participating patient | BIRADS assessments | BIRADS assessments |
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| Primary | Assess the Impact of Adjunctive US-guided DOT Data in the Management of Discordant Pathology Results | There were not any cases that were considered discordant in clinical practice as such there was not any data to present for this outcome measure. | Posted | Completion of enrollment for all patients (61 months), the imaging session took approximately 1 hour for the participating patient |
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