Cone Beam Breast CT for Breast Cancer Screening

Description

Up to one thousand and twenty-eight (1028) patients from screening and diagnostic population will be enrolled and consented to participate in the study to create an enriched data set. These women will be enrolled from annual screening population and diagnostic workup population. The enrolled patient will undergo KBCT scans within 4 weeks of her screening or diagnostic mammography exam and before breast biopsy occurs if biopsy is needed.

Conditions

Breast Cancer

Talk to us

Study Overview

On this page

Study Details

Study overview

Up to one thousand and twenty-eight (1028) patients from screening and diagnostic population will be enrolled and consented to participate in the study to create an enriched data set. These women will be enrolled from annual screening population and diagnostic workup population. The enrolled patient will undergo KBCT scans within 4 weeks of her screening or diagnostic mammography exam and before breast biopsy occurs if biopsy is needed.

Cone Beam Breast CT for Breast Cancer Screening

Cone Beam Breast CT for Breast Cancer Screening

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Port Orange

Port Orange Imaging Center, Port Orange, Florida, United States, 32129

Dacula

Women's Imaging Specialists, Dacula, Georgia, United States, 30019

Tifton

The Howard Center for Women's Health, Tifton, Georgia, United States, 31794

Knoxville

Knoxville Comprehensive Breast Center, Knoxville, Tennessee, United States, 37909

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Female sex of any ethnicity
  • * Age 40 years or older
  • * Scheduled for a routine screening mammography exam within 4 weeks.
  • * Female sex of any ethnicity
  • * Age 30 years or older
  • * Have an abnormality detected by Breast Self Exam (BSE), or Clinical Breast Exam (CBE), or have an abnormality detected by an imaging modality.
  • * Will undergo diagnostic mammography, prior to breast biopsy (if needed).
  • * Pregnancy
  • * Lactation
  • * Unknown pregnancy status AND
  • * has refused pregnancy testing and
  • * has refused to sign a pregnancy test waiver
  • * Women who are unable or unwilling to understand or to provide informed consent
  • * Women with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker.
  • * Women who are unable to tolerate study constraints.
  • * Women who have received radiation treatments to the thorax or breast area 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 Hodgkin's disease
  • * Women who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
  • * Women who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to):
  • * Tuberculosis
  • * Severe scoliosis Additional exclusion criteria due to machine limitations
  • * Patient's body weight is over the limit of the scanner table (440 lbs. or 200kg)

Ages Eligible for Study

30 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Koning Corporation,

Xiaohua Zhang, Ph.D., STUDY_DIRECTOR, Koning Corporation

Study Record Dates

2024-12-30