Breast Cancer
Conditions
Keywords
breast abnormality, ultrasound imaging, ultrasound contrast agent, subharmonic imaging
Brief summary
This is a non-randomized trial of 450 women with a breast abnormality, who are scheduled for a breast biopsy of this abnormality. The study will be conducted at two clinical sites. The primary objective of this trial is: To evaluate if quantitative 3D Subharmonic imaging (SHI) or pulse inversion harmonic imaging (HI) can improve the characterization of benign and malignant breast masses (independently or in combination with other imaging modes) compared to x-ray mammography, fundamental grayscale ultrasound (US) or power Doppler imaging (PDI). The secondary aim of this trial is: To compare quantitative (bifurcations & vessel length) and semi-quantitative (blood pool & parametric imaging) measures of the vascular morphology of breast lesions determined by pathology and by SHI.
Detailed description
This is an open-label, non-randomized trial that will be conducted at two clinical sites (the Breast Imaging Centers at Thomas Jefferson University (TJU) Hospital and University of California, San Diego (UCSD) Hospital). All 450 subjects will receive at most two IV bolus injections of Definity (Lantheus Medical Imaging, Billerica, MA), will undergo an unenhanced (baseline) and Definity contrast-enhanced US imaging study for evaluation of a breast mass or breast abnormality without mass, and will be scheduled to undergo a clinically indicated biopsy of the breast lesion under investigation.
Interventions
DRUG3D HI and SHI of UCA
Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)
Sponsors
National Cancer Institute (NCI)
Lantheus Medical Imaging
University of California, San Diego
Thomas Jefferson University
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
* Be a female diagnosed by x-ray mammography (performed within 90 days prior to the study procedure) as having a solid breast mass or abnormal area without a mass. * Be scheduled for a biopsy (core / excisional / lumpectomy) of the mass or region of abnormality or for mastectomy within 30 days after this study procedure. * Be at least 18 years of age. * Be medically stable. * If a female of child-bearing potential, must have a negative pregnancy test. * Have signed Informed Consent to participate in the study.
Exclusion criteria
* Males * Females who are pregnant or nursing. * Patients whose breast lesion is unequivocally a cyst by unenhanced US. * Patients currently on chemotherapy or with other primary cancers requiring systemic treatment. * Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example: * Patients on life support or in a critical care unit. * Patients with unstable occlusive disease (eg, crescendo angina) * Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia. * Patients with uncontrolled congestive heart failure (NYHA Class IV) * Patients with recent cerebral hemorrhage. * Patients with clinically significant and unstable renal and/or liver disease (eg, transplant recipients in rejection) * Patients who have undergone surgery within 24 hours prior to the study sonographic examination. * Patients with known hypersensitivity to perflutren * Patients who have received any contrast medium (X-ray, MRI, CT, of US) in the 24 hours prior to the research US exam * Patients with cardiac shunts. * Patients with congenital heart defects. * Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli. * Patients with confirmed or suspected liver lesions. * Patients with respiratory distress syndrome. * Patients who have had excisional biopsy/lumpectomy of the current area of interest within the past 6 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Breast Cancer Lesions Characterized as Malignant or Benign With 3D SHI, Harmonic Imaging (HI) or Power Doppler Imaging (PDI) | 2 hours | Characterization of benign and malignant breast cancer lesions is compared by each imaging method which evaluates vascular activity. Imaging methods to be compared are 3D Subharmonic imaging (SHI) or pulse inversion harmonic imaging (HI), fundamental grayscale ultrasound (US) or power Doppler imaging (PDI). Data will be analyzed qualitatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vascular Volume of Breast Lesions as Assessed by Subharmonic Imaging (SHI) Signal Intensity | 2 hours | Quantitative measures of the vascular volumes of breast lesions determined by SHI utilizing bifurcations and vessel length, and blood pool and parametric imaging |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 3D HI and SHI of UCA Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)
3D HI and SHI of UCA: Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI) | 219 |
| Total | 219 |
Baseline characteristics
| Characteristic | 3D HI and SHI of UCA |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 44 Participants |
| Age, Categorical Between 18 and 65 years | 175 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 204 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 14 Participants |
| Race (NIH/OMB) Black or African American | 97 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 108 Participants |
| Region of Enrollment United States | 219 participants |
| Sex: Female, Male Female | 219 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 219 |
| other Total, other adverse events | 0 / 219 |
| serious Total, serious adverse events | 0 / 219 |
Outcome results
Primary
Number of Breast Cancer Lesions Characterized as Malignant or Benign With 3D SHI, Harmonic Imaging (HI) or Power Doppler Imaging (PDI)
Characterization of benign and malignant breast cancer lesions is compared by each imaging method which evaluates vascular activity. Imaging methods to be compared are 3D Subharmonic imaging (SHI) or pulse inversion harmonic imaging (HI), fundamental grayscale ultrasound (US) or power Doppler imaging (PDI). Data will be analyzed qualitatively.
Time frame: 2 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3D HI and SHI of UCA | Number of Breast Cancer Lesions Characterized as Malignant or Benign With 3D SHI, Harmonic Imaging (HI) or Power Doppler Imaging (PDI) | Power Doppler Imaging (PDI) : Benign | 69 lesions |
| 3D HI and SHI of UCA | Number of Breast Cancer Lesions Characterized as Malignant or Benign With 3D SHI, Harmonic Imaging (HI) or Power Doppler Imaging (PDI) | Power Doppler Imaging (PDI) : Malignant | 24 lesions |
| 3D HI and SHI of UCA | Number of Breast Cancer Lesions Characterized as Malignant or Benign With 3D SHI, Harmonic Imaging (HI) or Power Doppler Imaging (PDI) | Power Doppler Imaging (PDI) : Not Characterized | 126 lesions |
| 3D HI and SHI of UCA | Number of Breast Cancer Lesions Characterized as Malignant or Benign With 3D SHI, Harmonic Imaging (HI) or Power Doppler Imaging (PDI) | 3D SHI : Benign | 58 lesions |
| 3D HI and SHI of UCA | Number of Breast Cancer Lesions Characterized as Malignant or Benign With 3D SHI, Harmonic Imaging (HI) or Power Doppler Imaging (PDI) | 3D SHI : Malignant | 25 lesions |
| 3D HI and SHI of UCA | Number of Breast Cancer Lesions Characterized as Malignant or Benign With 3D SHI, Harmonic Imaging (HI) or Power Doppler Imaging (PDI) | 3D SHI : Not Characterized | 136 lesions |
| 3D HI and SHI of UCA | Number of Breast Cancer Lesions Characterized as Malignant or Benign With 3D SHI, Harmonic Imaging (HI) or Power Doppler Imaging (PDI) | Harmonic Imaging (HI) : Benign | 3 lesions |
| 3D HI and SHI of UCA | Number of Breast Cancer Lesions Characterized as Malignant or Benign With 3D SHI, Harmonic Imaging (HI) or Power Doppler Imaging (PDI) | Harmonic Imaging (HI) : Malignant | 5 lesions |
| 3D HI and SHI of UCA | Number of Breast Cancer Lesions Characterized as Malignant or Benign With 3D SHI, Harmonic Imaging (HI) or Power Doppler Imaging (PDI) | Harmonic Imaging (HI) : Not Characterized | 211 lesions |
Secondary
Change in Vascular Volume of Breast Lesions as Assessed by Subharmonic Imaging (SHI) Signal Intensity
Quantitative measures of the vascular volumes of breast lesions determined by SHI utilizing bifurcations and vessel length, and blood pool and parametric imaging
Time frame: 2 hours
Population: breast cancer lesions
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 3D HI and SHI of UCA | Change in Vascular Volume of Breast Lesions as Assessed by Subharmonic Imaging (SHI) Signal Intensity | Peripheral benign lesions | 1.5 dB | Standard Deviation 0.09 |
| 3D HI and SHI of UCA | Change in Vascular Volume of Breast Lesions as Assessed by Subharmonic Imaging (SHI) Signal Intensity | Central malignant lesions | 1.72 dB | Standard Deviation 0.33 |
| 3D HI and SHI of UCA | Change in Vascular Volume of Breast Lesions as Assessed by Subharmonic Imaging (SHI) Signal Intensity | Central Benign lesions | 1.83 dB | Standard Deviation 0.16 |
| 3D HI and SHI of UCA | Change in Vascular Volume of Breast Lesions as Assessed by Subharmonic Imaging (SHI) Signal Intensity | peripheral malignant lesions | 1.26 dB | Standard Deviation 0.21 |