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Imaging

CBBCT Imaging for Breast Cancer

N/A
Recruiting
Research Sponsored by Koning Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnostic Group: Female sex of any ethnicity, Age 20 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)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after the cbbct imaging and mammography imaging
Awards & highlights

Study Summary

This trial will enroll 1,028 women from the screening and diagnostic population to create an enriched data set. The women will have KBCT scans within 4 weeks of their mammography exam and before breast biopsy, if needed.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not explicitly listed in the provided information, typical side effects from such imaging tests may include discomfort during the procedure and exposure to low levels of radiation which carries a small risk of harmful effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman over 20, found a breast abnormality, and will have a mammogram before any biopsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months after cbbct image review and mammography image review
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after cbbct image review and mammography image review for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Radiation Dose
Recall Rates

Trial Design

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.

Find a Location

Who is running the clinical trial?

Koning CorporationLead Sponsor
9 Previous Clinical Trials
1,664 Total Patients Enrolled
6 Trials studying Breast Cancer
618 Patients Enrolled for Breast Cancer
Xiaohua Zhang, Ph.D.Study DirectorKoning Corporation

Media Library

CBBCT Imaging (Imaging) Clinical Trial Eligibility Overview. Trial Name: NCT05036096 — N/A
Breast Cancer Research Study Groups: CBBCT Imaging Screening Patients, CBBCT Imaging Diagnostic Patients
Breast Cancer Clinical Trial 2023: CBBCT Imaging Highlights & Side Effects. Trial Name: NCT05036096 — N/A
CBBCT Imaging (Imaging) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05036096 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Cone Beam Breast CT for Breast Cancer Screening
2021. "Cone Beam Breast CT for Breast Cancer Screening". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05036096.
~221 spots leftby Dec 2024
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