3-D Super Resolution Ultrasound Microvascular Imaging

Breast Cancer Clinical Trial

Official title:

High Frame Rate 3-D Super Resolution Ultrasound Microvascular Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04136912
• Other study ID #: LCCC1915
• Secondary ID: R01CA220681
• Status: Recruiting
• Phase: Phase 2
• Start date: May 26, 2022
• Est. completion date: October 2024

Study information

• Verified date: October 2023
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: Carly Sronce
• Phone: 9199663262
• Email: carly_sronce[@]med.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Increasing the sensitivity and specificity of diagnostic imaging in patients at high risk for breast or thyroid cancer could provide substantial clinical benefit by improving diagnosis, preventing over-treatment, and reducing healthcare costs. Acoustic angiography is a new type of contrast enhanced ultrasound imaging which is specifically sensitive to microvascular structure and density. It evaluates tumor micro-vasculature and may provide a powerful prognostic tool for the diagnosis of breast cancer, and eventually for treatment evaluation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Thyroid Cancer
• Thyroid Neoplasms

Intervention

Drug:
• Definity
Perflutren will be administered in split doses using the dosing range and administration type IV bolus) within the perflutren prescribing information. When administered as a bolus, the package insert recommends 10 uL/kg patient weight administered within 30-60 seconds, followed by a 10mL saline flush with a second dose of 10 uL/kg patient weight 30 minutes following the first dose, if needed.

Device:
• Acoustic Angiography
Acoustic angiography imaging involves a research ultrasound scanner as well as conventional b-mode ultrasound to guide the location of the imaging. The conventional ultrasound will be conducted just prior to the acoustic angiography for localization. Imaging will be performed within the package insert guidelines for ultrasound system mechanical index (a measurement of output power) when imaging perflutren contrast agent (less than 0.8). Acoustic angiography imaging will be performed by trained medical personnel using mild compression to eliminate motion. Total imaging time is estimated to be less than 15 minutes.

Locations

Country	Name	City	State
United States	Univeristy of North Carolina Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of Acoustic Angiography; Breast Imaging (percent of positive scans)	Sensitivity of Acoustic Angiography in the analysis of know breast lesions will be evaluated by comparing image analyses to the pathological results for these lesions.	Calculated once all imaging is complete [Anticipated 1.5 years]
Primary	Specificity of Acoustic Angiography; Breast Imaging (percent of negative scans)	Specificity of Acoustic Angiography in the analysis of know breast lesions will be evaluated by comparing image analyses to the pathological results for these lesions.	Calculated once all imaging is complete [Anticipated 1.5 years]
Primary	Sensitivity of Acoustic Angiography; Thyroid Imaging (percent of positive scans)	Sensitivity of Acoustic Angiography in the analysis of know thyroid lesions will be evaluated by comparing image analyses to the pathological results for these lesions.	Calculated once all imaging is complete [Anticipated 1.5 years]
Primary	Specificity of Acoustic Angiography; Thyroid Imaging (percent of negative scans)	Specificity of Acoustic Angiography in the analysis of know thyroid lesions will be evaluated by comparing image analyses to the pathological results for these lesions.	Calculated once all imaging is complete [Anticipated 1.5 years]
Secondary	Area Under the Curve of Acoustic Angiography (arbitrary units)	To compare the area under the curve (AUC) of acoustic angiography to the AUC of the b-mode ultrasound	Calculated once all imaging is complete [Anticipated 1.5 years]
Secondary	Radiologist preference (Arbitrary units)	To compare radiologist preference of acoustic angiography to conventional b-mode ultrasound for each lesion characteristic (shape, margins, and vascularity)	Calculated once all imaging is complete [Anticipated 1.5 years]
Secondary	Sensitivity of acoustic angiography compared to conventional ultrasound: Breast (arbitrary units)	To compare (using a reader study) the sensitivity of acoustic angiography to the sensitivity of conventional b-mode ultrasound in evaluation of known breast lesions for predicting malignancy.	Calculated once all imaging is complete [Anticipated 1.5 years]
Secondary	Specificity of acoustic angiography compared to conventional ultrasound: Breast (arbitrary units)	To compare (using a reader study) the specificity of acoustic angiography to the specificity of conventional b-mode ultrasound in evaluation of known breast lesions for predicting malignancy.	Calculated once all imaging is complete [Anticipated 1.5 years]
Secondary	Sensitivity of acoustic angiography compared to conventional ultrasound: Thyroid (arbitrary units)	To compare (using a reader study) the sensitivity of acoustic angiography to the sensitivity of conventional b-mode ultrasound in evaluation of known thyroid lesions for predicting malignancy.	Calculated once all imaging is complete [Anticipated 1.5 years]
Secondary	Specificity of acoustic angiography compared to conventional ultrasound: Thyroid (arbitrary units)	To compare (using a reader study) the specificity of acoustic angiography to the specificity of conventional b-mode ultrasound in evaluation of known thyroid lesions for predicting malignancy.	Calculated once all imaging is complete [Anticipated 1.5 years]