Clinical trial · Interventional
3-D Super Resolution Ultrasound Microvascular Imaging
High Frame Rate 3-D Super Resolution Ultrasound Microvascular Imaging
NCT04136912CI-TRIAL-00096303terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Grant ended
Summary
Brief summary (as posted)
This is a 3-arm single center study of 45 patients. These cohorts will include 15 breast patients scheduled to undergo a biopsy, and 15 thyroid patients scheduled to undergo fine needle aspiration, biopsy, or thyroidectomy that consent to undergo an acoustic angiography in conjunction with b-mode ultrasound prior to their scheduled biopsy. Prior to imaging clinical patients, the third arm will include 15 healthy volunteers that will be imaged to optimize imaging parameters.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acoustic Angiography | Device | — | UNRESOLVED |
| Definity | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Breast Imaging Cohort
- description
- A total of 15 women with known breast lesions that are already scheduled to undergo a clinical biopsy
- interventionNames
- Drug: Definity
- Device: Acoustic Angiography
- type
- EXPERIMENTAL
- label
- Thyroid Imaging Cohort
- description
- A total of 15 participants with known thyroid lesions that are already scheduled to undergo a clinical biopsy
- interventionNames
- Drug: Definity
- Device: Acoustic Angiography
- type
- EXPERIMENTAL
- label
- Healthy Volunteers Cohort
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Healthy Volunteers Inclusion Criteria * Able to provide informed consent * Negative urine pregnancy test in women of child-bearing potential Exclusion Criteria * Institutionalized subject (prisoner or nursing home patient) * Critically ill or medically unstable and whose critical course during the observation period would be unpredictable (e.g., chronic obstructive pulmonary disease (COPD) * Known hypersensitivity to perflutren lipid (Definity®) * Active cardiac disease including any of the following: * Severe congestive heart failure * Unstable angina. * Severe arrhythmia * Myocardial infarction within 14 days prior to the date of proposed Definity® administration. * Pulmonary hypertension * Cardiac shunts Breast Imaging Patients Inclusion Criteria * Women * Patient had a diagnostic breast ultrasound study performed at UNC * Scheduled for a core needle or surgical breast biopsy of at least one breast lesion that is 2 cm or less in size and 3 cm in depth from the skin surface * Able to provide informed consent * Negative urine pregnancy test in women of child-bearing potential * BIRADS score of 4 or 5. Exclusion Criteria * Male * Institutionalized subject (prisoner or nursing home patient) * Critically ill or medically unstable and whose critical course during the observation period would be unpredictable (e.g., chronic obstructive pulmonary disease (COPD) * Sonographically visible breast lesion larger than 2cm or greater than 3cm in depth from the skin surface * Known hypersensitivity to perflutren lipid (Definity®) * Active cardiac disease including any of the following: * Severe congestive heart failure * Unstable angina. * Severe arrhythmia * Myocardial infarction within 14 days prior to the date of proposed Definity® administration. * Pulmonary hypertension * Cardiac shunts Thyroid Imaging Patients Inclusion Criteria * Patient had a diagnostic thyroid ultrasound study performed at UNC * TIRADS risk score of 4c or 5 * Scheduled for a core needle or surgical thyroid biopsy, fine needle aspiration, or thyroidectomy of at least one sonographically visible thyroid lesion that is 3 cm in depth from the skin surface * Able to provide informed consent * Negative urine pregnancy test in women of child-bearing potential Exclusion Criteria * Institutionalized subject (prisoner or nursing home patient) * Critically ill or medically unstable and whose critical course during the observation period would be unpredictable (e.g., chronic obstructive pulmonary disease (COPD) * Known hypersensitivity to perflutren lipid (Definity®) * Active cardiac disease including any of the following: * Severe congestive heart failure * Unstable angina. * Severe arrhythmia * Myocardial infarction within 14 days prior to the date of proposed Definity® administration. * Pulmonary hypertension * Cardiac shunts
References
Publications (0)
Data not yet available
No reference posted for this study.