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Cone Beam Breast CT for Breast Cancer Screening

NCT05036096 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1024

Last updated 2026-02-05

No results posted yet for this study

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

Interventions

DEVICE

CBBCT Imaging

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

DEVICE

Digital Mammography

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

Sponsors & Collaborators

  • Koning Corporation

    lead INDUSTRY

Principal Investigators

  • Xiaohua Zhang, Ph.D. · Koning Corporation

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-30
Primary Completion
2026-12-29
Completion
2026-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05036096 on ClinicalTrials.gov