Cone Beam CT for Breast Cancer Screening

Not currently recruiting at 3 trial locations
XZ
Overseen ByXiaohua Zhang, Ph.D.
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Koning Corporation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve breast cancer screening techniques by testing a new imaging method called Cone Beam CT (CBBCT). Participants will either come from a routine screening group or have been flagged for possible breast issues requiring further diagnostic testing. The trial will compare CBBCT imaging with regular mammograms (digital mammography) to determine if it provides better data before any necessary biopsies. Women scheduled for routine mammograms or those with detected breast abnormalities might be suitable candidates. As an unphased trial, this study offers participants the opportunity to contribute to advancements in breast cancer screening technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on imaging and does not mention medication restrictions.

What prior data suggests that CBBCT Imaging is safe for breast cancer screening?

Research has shown that Cone Beam CT (CBBCT) imaging is a promising tool for breast cancer screening. Studies have found that this method provides clear, three-dimensional images of the breast, allowing doctors to see more detail than traditional mammograms.

The FDA has approved the CBBCT device for breast imaging, confirming its safety for diagnosing breast issues. While standard precautions apply, as with most imaging devices, no major safety concerns have been reported.

Overall, patients generally tolerate CBBCT imaging well. It offers a detailed view of breast tissue and is considered safe for both screening and diagnosis.12345

Why are researchers excited about this trial?

Researchers are excited about Cone Beam CT (CBBCT) for breast cancer screening because it offers a promising new imaging method. Unlike traditional digital mammography, CBBCT provides 3D images, which can improve the detection of tumors, especially in dense breast tissue. This technique could potentially reduce the number of false positives and unnecessary biopsies. By delivering a more detailed view with less discomfort, CBBCT aims to enhance early detection and improve the overall screening experience for patients.

What evidence suggests that CBBCT imaging is effective for breast cancer screening?

This trial will evaluate Cone Beam CT (CBBCT) for breast cancer screening. Research has shown that CBBCT surpasses digital mammography in diagnosing breast cancer. Studies indicate that CBBCT covers more breast tissue, enabling it to detect cancer more effectively. Although CBBCT is more accurate than standard digital mammography, it is slightly less effective than MRI. CBBCT proves particularly helpful in early breast cancer detection, which is crucial for successful treatment. While CBBCT remains under investigation, these findings suggest it could become a valuable tool for breast cancer screening and diagnosis.23467

Who Is on the Research Team?

XZ

Xiaohua Zhang, Ph.D.

Principal Investigator

Koning Corporation

Are You a Good Fit for This Trial?

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
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Imaging

Participants undergo bilateral or unilateral CBBCT imaging within 4 weeks of their screening or diagnostic mammography exam

4 weeks
1 visit (in-person)

Follow-up

Participants are monitored for recall rates and radiation dose after CBBCT and mammography imaging

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • CBBCT Imaging
  • Digital Mammography

Trial Overview

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.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: CBBCT Imaging Screening PatientsExperimental Treatment2 Interventions
Group II: CBBCT Imaging Diagnostic PatientsExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Koning Corporation

Lead Sponsor

Trials
10
Recruited
2,700+

Citations

Diagnostic accuracy of cone-beam breast computed ... - PMC

The CBBCT has greater diagnostic accuracy than digital mammography (DM), although its diagnostic performance is marginally inferior to that of magnetic ...

Head-to-head comparison of cone-beam breast computed ...

The diagnostic performance of CBBCT for primary breast cancer was better than that of MG. However, the results of both the CBBCT and MG are based on studies ...

Cone-Beam CT for Breast Imaging - AJR Online

Breast tissue coverage was statistically significantly better with cone-beam breast CT than with mammography in the lateral (p < 0.0001), medial (p < 0.0001), ...

Emerging Clinical Applications for Cone Beam Breast CT

Studies have found that non-contrast CBBCT generally outperforms digital mammography, and contrast-enhanced CBBCT is exceptionally effective in ...

Cone Beam Computed Tomography of the Breast

They added that CBBCT might be a useful modality for breast cancer detection and that more prospective studies on CBBCT application should be ...

summary of safety and effectiveness data (ssed)

WARNINGS AND PRECAUTIONS. The warnings and precautions can be found in the Koning Breast CT (CBCT1000) labeling. V. DEVICE DESCRIPTION. The Koning Breast CT ( ...

Cone Beam Computed Tomography for Breast Imaging

The goal is to accumulate a body of evidence to provide data to incorporate CBCT into the diagnostic work-up of breast lesions. Official Title.