Koning Breast Computed Tomography Guided Biopsy

NCT01750320 | Completed Phase 1 DMC

• 2 other identifiers: KBCT-004W81XWH-09-1-0441
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to show that the accuracy of Koning Breast CT-guided biopsy is at least equivalent to that of stereotactic-guided biopsy.

Conditions

Breast Cancer

Keywords

Breast CT; Biopsy

Outcome Measures

Primary Outcomes (1)

• The accuracy of Koning breast CT-guided biopsy

  The goal of this study is to evaluate the concordance of Koning Breast CT-guided Biopsy (KBCT-GBx) results to diagnostic work-up imaging (at least mammographic) and KBCT imaging and to verify that the localization and guidance accuracy of KBCT-GBx is at least equivalent to stereotactic-guided biopsy to validate the localization and guidance accuracy of KBCT-GBx.

  about 1 year

Study Arms (1)

Koning Breast CT - guided Biopsy

EXPERIMENTAL

Device: Koning Breast CT-guided Biopsy

Interventions

Koning Breast CT-guided Biopsy DEVICE

The breast will be positioned and stabilized in the grid/compression device. Four KBCT scans will be taken to guide the vacuum-assisted biopsy procedure.

Koning Breast CT - guided Biopsy

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female at least 35 years of age of any ethnicity
• Lesion seen on mammography
• Diagnostic report read as BI-RADS 4 or 5
• Will undergo biopsy no later than four weeks from date of mammogram
• Is able to undergo informed consent

You may not qualify if:

• Pregnancy
• Lactation
• Subjects with breast implants
• Subjects with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pacemaker.
• Subjects who are unable to tolerate study constraints.
• Subjects who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to)
• Treatment for enlarged thymus gland as an infant
• Irradiation for benign breast conditions, including breast inflammation after giving birth
• Treatment for Hodgkins disease
• Subjects who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
• Subjects who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)
• Tuberculosis
• Severe scoliosis

Sponsors & Collaborators

• Koning Corporation: lead
• Elizabeth Wende Breast Care, LLC: collaborator

Study Sites (1)

Elizabeth Wende Breast Care

Rochester, New York, 14620, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: December 17, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 7, 2018

Record last verified: 2018-03

Locations

US (1)