Breast Biopsy
Conditions
Brief summary
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.
Interventions
DEVICEHand-held hybrid probe
Consists of a commercially available US transducer located in the middle and near-infrared source and detector optical fibers distributed at the periphery
Sponsors
National Cancer Institute (NCI)
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
* Lesions located in the darkly pigmented nipple-areolar complex area * Subjects with breast implants * Abnormality in the mirror image location of the contralateral breast. * Additional abnormalities in the same region of the breast that would be included in US-guided DOT imaging of the abnormality undergoing biopsy * Previous breast irradiation of the mirror image location of the contralateral breast * Lesions located at previous biopsy sites when biopsy occurred within the last six months. * Pregnancy * Superficial abnormalities located entirely within (i.e. less than) 5mm of the overlying skin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Completion of enrollment for all patients (61 months), the imaging session took approximately 1 hour for the participating patient | -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. |
| 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 | Completion of enrollment for all patients (61 months), the imaging session took approximately 1 hour for the participating patient | -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. |
| 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 | — |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| US-DOT (US/NIR) Imaging * US-DOT (US/NIR) Imaging Exam
* Breast biopsy or FNA performed (standard of care)
* A hand-held hybrid probe will be used for the scans | 298 |
| Total | 298 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | DOT system problem | 1 |
| Overall Study | No biopsy after physician review | 4 |
| Overall Study | Patient withdrew | 2 |
| Overall Study | Poor DOT probe contact with breast | 2 |
| Overall Study | Switched to x-ray guided biopsy | 3 |
Baseline characteristics
| Characteristic | US-DOT (US/NIR) Imaging |
|---|---|
| Age, Continuous | 50 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 287 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 86 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 201 Participants |
| Region of Enrollment United States | 298 participants |
| Sex: Female, Male Female | 298 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 286 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 286 |
Outcome results
Primary
Assess the Impact of Adjunctive US-guided DOT Data in the Management of Discordant Pathology Results
Time frame: Completion of enrollment for all patients (61 months), the imaging session took approximately 1 hour for the participating patient
Population: 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.
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.
Time frame: Completion of enrollment for all patients (61 months), the imaging session took approximately 1 hour for the participating patient
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| US-DOT (US/NIR) Imaging | 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 | 5 BIRADS assessments |
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.
Time frame: Completion of enrollment for all patients (61 months), the imaging session took approximately 1 hour for the participating patient
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| US-DOT (US/NIR) Imaging | 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 | 148 BIRADS assessments |