Koning Breast Computed Tomography Guided Biopsy

Koning Health

Status and phase

Completed

Phase 1

Conditions

Breast Cancer

Treatments

Device: Koning Breast CT-guided Biopsy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01750320

KBCT-004

W81XWH-09-1-0441 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

4 patients

Sex

Female

Ages

35+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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