Breast Cancer
Conditions
Keywords
Breast Cancer, Definity, Ultrasound
Brief summary
1. Evaluate quantitative VCEUS imaging for determining early breast cancer response to neoadjuvant chemotherapy and compare results to co-temporal volume change on grayscale ultrasound and post-treatment mammography findings utilizing final surgical pathology and clinical outcome. 2. Assess incremental benefit of quantitative VCEUS to planar CEUS tumor perfusion measurements and enhancement patterns in predicting tumor response to adjuvant treatment in clinical studies. The contrast agent Definity® is FDA approved for use as a contrast agent during ultrasound (echocardiography) of the heart. Definity® will be used off-label (during ultrasound of the breast) in this study. The administration of Definity® during this study will follow total dose guidelines approved by the FDA.
Interventions
DIAGNOSTIC_TEST2D US grayscale plus quantitative VCEUS
This is a pilot study to evaluate quantitative VCEUS imaging for determining early breast cancer response to neoadjuvant chemotherapy, comparing results with volume change on grayscale US and planar CEUS, and correlating imaging findings with pathological response on surgical specimens.
Sponsors
American Cancer Society, Inc.
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients (age 19 years or older). 2. Patients with newly diagnosed and untreated stage II and III breast cancer scheduled to undergo neoadjuvant chemotherapy. 3. Patients with signed informed consent.
Exclusion criteria
1. Any history of prior radiation or chemotherapy for breast cancer. 2. Patients who only have non-measurable disease. 3. Patients who are medically unstable. 4. Patients with other primary cancers requiring systemic treatment. 5. Patients with cardiac shunts. 6. Patients with unstable cardiopulmonary conditions. 7. Patients with known pulmonary hypertension. 8. Patients with known hypersensitivity to any component of Definity (R) microbubble contrast. 9. Patients who are pregnant, breast-feeding or are planning to become pregnant during the study duration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Volume Measure Using Grayscale US | Baseline (first visit) | Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters. |
| VCEUS Perfusion Time to Peak | Baseline | Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathology Residual Tumor | 6 months | Pathology residual tumor measured in millimeters |
Countries
United States
Participant flow
Recruitment details
A total of 22 patients was planned in this pilot study through the UAB Interdisciplinary Breast Center. However, due to early termination of the study, only six breast cancer patients were enrolled. Each participant received both interventions (2D ultrasound grayscale vs Definity Volume contrast enhanced ultrasound).
Pre-assignment details
Recruitment for this study started in June 2015. The primary completion point was reached at July 2016, and study completion July 2016. The study was conducted at the University of Alabama at Birmingham.
Participants by arm
| Arm | Count |
|---|---|
| Evaluation of VCEUS to Determine Response to Chemotherapy Patients with breast cancer receiving neoadjuvant chemotherapy will undergo quantitative VCEUS imaging and 2D grayscale imaging as follows:
1. prior to initiation of treatment (baseline);
2. at 14 (± 4 days) after initiation of neoadjuvant chemotherapy (early treatment);
3. at 28 days (± 4 days) after initiation of neoadjuvant chemotherapy (inter-regimen);
4. at completion of therapy prior to definitive surgery (usually 2-3 months after initiation of treatment). Each patient will undergo a total of four VCEUS examinations.
Definity (Perflutren Lipid Microspheres): This is a pilot study to evaluate quantitative VCEUS imaging for determining early breast cancer response to neoadjuvant chemotherapy, comparing results with volume change on grayscale US and planar CEUS, and correlating imaging findings with pathological response on surgical specimens. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Evaluation of VCEUS to Determine Response to Chemotherapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Region of Enrollment United States | 6 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Tumor Volume Measure Using Grayscale US
Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters.
Time frame: Baseline (first visit)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Grayscale Ultrasound | Tumor Volume Measure Using Grayscale US | 38.2 millimeters | Standard Deviation 23.9 |
Primary
Tumor Volume Measure Using Grayscale US
Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters.
Time frame: Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Grayscale Ultrasound | Tumor Volume Measure Using Grayscale US | 34.0 millimeters | Standard Deviation 29.9 |
Primary
Tumor Volume Measure Using Grayscale US
Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Grayscale Ultrasound | Tumor Volume Measure Using Grayscale US | 27.3 millimeters | Standard Deviation 22.4 |
Primary
Tumor Volume Measure Using Grayscale US
Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Grayscale Ultrasound | Tumor Volume Measure Using Grayscale US | 18.0 millimeters | Standard Deviation 9.01 |
Primary
VCEUS Perfusion Time to Peak
Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds.
Time frame: Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Grayscale Ultrasound | VCEUS Perfusion Time to Peak | 85.7 seconds | Standard Deviation 24.4 |
Primary
VCEUS Perfusion Time to Peak
Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds.
Time frame: Baseline
Population: 1 subject did not complete this timepoint due to machine down
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Grayscale Ultrasound | VCEUS Perfusion Time to Peak | 88.5 seconds | Standard Deviation 12.9 |
Primary
VCEUS Perfusion Time to Peak
Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Grayscale Ultrasound | VCEUS Perfusion Time to Peak | 88.3 seconds | Standard Deviation 29.8 |
Primary
VCEUS Perfusion Time to Peak
Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Grayscale Ultrasound | VCEUS Perfusion Time to Peak | 105.16 seconds | Standard Deviation 43.2 |
Secondary
Pathology Residual Tumor
Pathology residual tumor measured in millimeters
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Grayscale Ultrasound | Pathology Residual Tumor | 34.5 millimeters | Standard Deviation 28.8 |