Cone Beam Breast CT for Breast Cancer Screening

NCT05036096 | Active Not Recruiting FDA Device

• 1 other identifier: 2021SCR
• Study Type: interventional
• Target: 1,024
• Locations: 1 country
• Sites: 4

Brief Summary

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

Outcome Measures

Primary Outcomes (2)

• Radiation Dose

  The radiation dose of CBBCT imaging and Mammography imaging

  3 months after the CBBCT imaging and Mammography imaging

• Recall Rates

  The overall recall rates of CBBCT imaging and Mammography imaging

  3 months after CBBCT image review and Mammography image review

Study Arms (2)

CBBCT Imaging Screening Patients

EXPERIMENTAL

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

Device: CBBCT Imaging; Device: Digital Mammography

CBBCT Imaging Diagnostic Patients

EXPERIMENTAL

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

Device: CBBCT Imaging; Device: Digital Mammography

Interventions

CBBCT Imaging DEVICE

Both breasts will be scanned by CBBCT. Only one breast will be scanned if the patient had mastectomy.

CBBCT Imaging Diagnostic Patients; CBBCT Imaging Screening Patients

Digital Mammography DEVICE

Both breasts will take digital mammography standard views (CC, MLO) Only one breast will take digital mammography standard views if the patient had mastectomy.

CBBCT Imaging Diagnostic Patients; CBBCT Imaging Screening Patients

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Screening Group:
• Female sex of any ethnicity
• Age 40 years or older
• Scheduled for a routine screening mammography exam within 4 weeks.
• Diagnostic Group:
• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Koning Corporation: lead

Study Sites (4)

Port Orange Imaging Center

Port Orange, Florida, 32129, United States

Location

Women's Imaging Specialists

Dacula, Georgia, 30019, United States

Location

The Howard Center for Women's Health

Tifton, Georgia, 31794, United States

Location

Knoxville Comprehensive Breast Center

Knoxville, Tennessee, 37909, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Xiaohua Zhang, Ph.D.

  Koning Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two groups of patients: Screening: patients who are scheduled for annual breast cancer screening. Diagnostic: patients who have an abnormality detected by Breast Self Exam, or Clinical Breast Exam (CBE), or have an abnormality detected by an imaging modality.

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 5, 2021
• Study Start: October 30, 2021
• Primary Completion (Estimated): December 29, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)