Cone Beam CT for Breast Cancer Screening

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Koning Corporation

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial uses a special 3D breast scan called KBCT to get detailed images of the breast. It targets women aged 40 and above who are undergoing routine breast checks. The scan takes many pictures from different angles to create a clear 3D image, helping doctors see any problems more easily.

Eligibility Criteria

This trial is for women seeking breast cancer screening or diagnostic workup. Eligible participants are over 40 years old for routine screening, or over 20 with detected abnormalities for diagnostics. Exclusions include lactation, physical limitations, excessive prior x-rays, pregnancy without testing consent, inability to understand the study, and previous radiation treatments.

Inclusion Criteria

I am a woman over 20, found a breast abnormality, and will have a mammogram before any biopsy.

I am a woman aged 40 or older scheduled for a routine mammogram within the next 4 weeks.

Exclusion Criteria

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)

I have had radiation therapy to my chest area for any reason.

Pregnancy

+5 more

Participant Groups

The trial is evaluating Cone Beam Breast CT (CBBCT) imaging against standard Digital Mammography in detecting breast cancer. Up to 1028 women will undergo CBBCT scans within four weeks of their mammogram before any potential biopsy to compare effectiveness.

2Treatment groups

Experimental Treatment

Group I: CBBCT Imaging Screening PatientsExperimental Treatment2 Interventions

Patient undergo bilateral CBBCT imaging (or unilateral CBBCT imaging if the patient had mastectomy) within 4 weeks of screening mammography.

Group II: CBBCT Imaging Diagnostic PatientsExperimental Treatment2 Interventions

Patient undergo bilateral CBBCT imaging (or unilateral CBBCT imaging if the patient had mastectomy) within 4 weeks of diagnostic mammography.