NCT04561297

Assessing the Utility of Tissue Dielectric Constant (TDC) Measurements to Differentiate Breast Cancer From Healthy Breasts

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Nova Southeastern University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with pending breast biopsies will have the tumor site's tissue dielectric constant (TDC) measured prior to the biopsy. Similar TDC measurements will be made at a standard breast site on the biopsied breast and on mirrored sites on the non-affected breast.

Detailed description

Patients with pending breast biopsies will have the tumor site's tissue dielectric constant (TDC) measured prior to the biopsy. Similar TDC measurements will be made at a standard breast site on the biopsied breast and on mirrored sites on the non-affected breast. Values obtained at the biopsy site will be compared against the outcome of the biopsy analysis: benign vs. malignant. In addition the measurements obtained at the standardized site for all breasts will be used to establish a set of reference values to characterize breast TDC values. In addition, inter-breast differentials will be used to characterize these ranges for future studies and clinical assessments.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	TDC differential value	TDC measurements in all patients agreeing to participate who are scheduled for a biopsy of a breast tumor or mass

Timeline

• Start date: 2019-02-08
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2020-09-23
• Last updated: 2022-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study