N/A N=45

ARFI, VisR and DDAI Ultrasound for Improving Discrimination of Malignant and Unresponsive Breast Cancer

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT03785782 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2024

Primary outcome: Primary: Correlation of Peak Displacement (PD) for Detecting Malignancy — 4.5803; 8.628 microns — p=0.2988

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Ultrasound (Device)
Age: Adult, Older Adult · 30+ yrs
Sex: Female
Sponsor: UNC Lineberger Comprehensive Cancer Center
Primary completion: Jul 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Correlation of Peak Displacement (PD) for Detecting Malignancy	4.5803; 8.628	0.2988
PRIMARY Weighted Correlation Between Peak Displacement (PD) to Predict Response to Neoadjuvant Chemotherapy.	2.4715; 6.7281; 2.5268; 3.2511	0.36
PRIMARY Weighted Correlation Between Displacement at a Given Time (TD) for ARFI to Predict Response to Neoadjuvant Chemotherapy	2.3495; 6.1222; 2.2757; 3.0156	0.43
PRIMARY Weighted Correlation Between Relative Elasticity (RE) to Predict Response to Neoadjuvant Chemotherapy.	177.69; 89.41; 190.51; 164.42	0.42
PRIMARY Weighted Correlation Between Relative Viscosity (RV) to Predict Response to Neoadjuvant Chemotherapy.	384.55; 164.12; 362.58; 281.54	0.45
PRIMARY Weighted Correlation Between Tissue Mass (TM) for VisR to Predict Response to Neoadjuvant Chemotherapy.	0.02; 0.05; 0.03; 0.05	0.18
PRIMARY Comparison of ARFI PD Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.	3.56; 2.11; 7.99; 6.06; 2.52; 2.11	0.78
PRIMARY Comparison of Ratio of ARFI PD Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.	155.59; 170.15; 69.45; 107.00; 179.02; 185.64	0.45
PRIMARY Weighted Correlation Between Ratio of RV Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.	289.93; 386.65; 144.27; 191.86; 322.84; 332.70	0.34
PRIMARY Correlation of Displacement at a Given Time (TD) for Detecting Malignancy.	4.16; 7.15	0.7465
PRIMARY Correlation of Relative Elasticity (RE) for Detecting Malignancy.	125.59; 89.88	0.0466 sig
PRIMARY Correlation of Relative Viscosity (RV) for Detecting Malignancy.	194.43; 137.60	0.1567
PRIMARY Correlation of Tissue Mass (TM) for VisR for Detecting Malignancy	0.46; 0.34	0.1837
PRIMARY Correlation of Ratio of ARFI PD Values at 90o Versus 0o Transducer Orientations for Detecting Malignancy.	4.88; 4.30; 9.84; 8.10	0.7447
PRIMARY Correlation of Ratio of VisR RE Values at 90o Versus 0o Transducer Orientations for Detecting Malignancy.	139.66; 117.26; 77.47; 84.06	0.0739
PRIMARY Correlation of Ratio of VisR RV Values at 90o Versus 0o Transducer Orientations for Detecting Malignancy.	161.10; 205.46; 113.67; 157.49	0.9995

Summary

Purpose: The purpose of this study is to evaluate in vivo the diagnostic relevance of ultrasound-derived metrics for stiffness, elasticity, viscosity, and anisotropy. Participants: Forty women with breast lesions that have a BIRADS-4 or BIRADS-5 rating and forty women undergoing neoadjuvant chemotherapy (NAC) for malignant breast lesions will be recruited. Subjects will be recruited from the Breast Imaging Division of UNC Hospitals. Procedures (methods): In this exploratory clinical study, the investigators will attempt to demonstrate that ARFI, VisR, and DDAI ultrasound reliably detect malignant breast masses (Aim #1) and distinguish masses that respond to chemotherapy from those that do not (Aim #2). The ARFI, VisR, and DDAI imaging location will be on the surface of the breast, above the suspicious or malignant mass. This unblinded, open-label, exploratory study will be conducted in 40 women with diagnosed BIRADS-4 or -5 masses in Aim #1 and in 40 women with malignant masses undergoing neoadjuvant chemotherapy (NAC) in Aim #2.

Eligibility Criteria

Inclusion Criteria

Aim 1:

Inclusion Criteria

Patients are 30-90 years of age
Patients have breast masses with BIRADS 4a, 4b, 4c, or 5 rating
Lesion is sonographically visible with B-Mode ultrasound on diagnostic workup
Informed consent obtained and signed

Aim 2:

Inclusion Criteria

Patients are 30-90 years
Patients who are or will be undergoing neoadjuvant chemotherapy (NAC) for stage 2 or 3 malignant breast lesions
Lesion is sonographically visible with B-Mode ultrasound on diagnostic workup
Informed consent is obtained and signed

Exclusion Criteria: Subjects who meet any of the exclusion criteria will be excluded from study participation for both Aim 1 and Aim 2.

Inability to provide informed consent
Inability to communicate in English
Inability to remain motionless for 15 minutes
Suspicious or malignant breast mass deeper than 3 cm from skin surface
Previous biopsy or surgery to the site of the suspicious or malignant mass
Patients who are pregnant
Patients who are lactating
Patients with a history of masectomy
Patients with breast implants

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03785782). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.