Frequently Asked Questions
About Koning Vera (KBCT)
Radiation dose of Koning Vera was measured to be in the same range as diagnostic mammograms. KBCT biopsy imaging dose was measured as a 50% reduction when compared to stereotactic biopsies.
Read more here:
After rigorous study, Koning Vera obtained FDA PMA approval for both breast CT and 3D-guided biopsy. This is the highest bar of approval for the FDA.
Read more here:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130025
Effective 1/2021, the American Medical Association provided Breast CT with 6 dedicated CPT codes. The codes are now being accepted by both public and private payers.
Surveys have shown the majority of women who receive mammograms consider the experience to be painful due to compression. Unfortunately, all mammograms require rigorous breast compression which is the only way for 2-dimensional mammography X-rays to penetrate the breast tissue.
Additional surveys have shown, pain from compression leads many women to forego the recommendations to obtain an annual mammogram. Not complying with the recommendations often results in late-stage cancer diagnoses where treatment outcomes are not as promising in comparison to cancer found earlier.
Breast CT, “KBCT”, is the first X-ray-based breast imaging device that does not require painful compression and produces a true 3-dimensional image of the breast at the same dose as a 2-dimensional compressional mammogram and the exam time is a rapid 7 seconds per breast. Koning believes the vast majority of women will find this a welcome improvement from mammography and Breast CT should have a positive impact on those currently not complying with the recommendations.
Read more here:
https://www.jpsmjournal.com/article/S0885-3924(02)00598-5/pdf
Compressional DBT has been marketed as 3D when, in fact, it is not true 3D. For an image to be true 3D it must be "isotropic" (the same from any angle). Breast CT is true 3D - the image can be viewed from any angle equally, which eliminates any overlapping structures. It acquires true 3D images without compression.
By the end of 2023, KBCT has been installed in 25 facilities globally, and is rapidly expanding.
At this time, KBCT is in clinical use in Atlanta, GA, Birmingham, AL, Knoxville, TN, Little Rock, AR, and New York City, NY.
On January 1, 2021, the AMA listed 6 CPT codes for Breast CT. To date, the reimbursement has proven to be higher than DBT reimbursement from most insurance payers.
The Breast CT prone biopsy is rather quick depending on the patient. The average biopsy can be completed in around 15 minutes. The two most important factors regarding Breast CT biopsy are targeting accuracy by utilizing isotropic 3D targeting and the ability to reduce the number of images which equates to a radiation exposure level which is 50% less dose when compared to stereo biopsy.
The Koning website illustrates Breast CT images compared to DBT images.
Create an account with Koning to access image demos: Register Here
Cone beam imaging has already expanded to maxillofacial imaging, dental imaging, ENT imaging and soon we will see extremity imaging with Cone Beam CT. It is anticipated that Cone Beam imaging will eventually enter into angiography.
We believe the screening indication is the most important project currently in the product plan. The clinical trial is underway and the anticipated timing for a screening indication is by end of 2024.
The clinical trial has been registered on clinicaltrials.gov: https://clinicaltrials.gov/ct2/show/NCT05036096
Over 130 papers have been published on the technology. Please visit Our Publications for access to the papers.
Breast CT vs. Other Imaging Options
- Breast CT is an efficient (7 second) breast imaging device that obtains a low dose, isotropic, 360° image of the breast. This allows radiologists to see the condition of the breast from multiple angles and in a true 3-dimensional image without multiple requests for additional views.
- Patients will no longer endure the discomfort from compression and the patient with implants will no longer be required to receive double the pictures which means double the dose to the breast tissue.
- Breast CT produces one 360° image of the breast, and the patient is done.
Mainly, no compression to the breast. Moreover, Breast CT completely eliminates overlapping structures by imaging all the way around the breast rather than imaging with a limited sweep angle tomographic sweep.
No this is not true. The FDA tested the Breast CT device and stated the radiation dose was in the same range as diagnostic mammography.
Read more here:
https://www.koninghealth.com/news-insights/publications
- Unilateral or bi-lateral imaging of the breast with or without contrast.
- X-ray guided 3-dimensionally targeted biopsy
- Contrast-enhanced imaging when indicated
- Breast implant imaging without displacement views
- Neoadjuvant therapy monitoring imaging
We suggest a minimum of 10' x 14’ room size and the electric power requirement is the same as mammography – 208 to 240 Volt, 35 Amp single phase.
The room doesn't require special shielding. KBCT can be installed with an operator console with a glass shield as extra protection to the technologist.
Scientific articles have been published in peer-reviewed journals and conferences. Recent studies show that:
1. CBBCT has comparable diagnostic performance to breast MRI in patients with high suspicion of or known breast malignancy and should be considered as a substitute in patients that cannot undergo breast MRI. ---- SBI 2022
2. CE-CBBCT showed substantial agreement and comparable inter-reader reliability with MRI for BPE evaluation. ---- Journal of European Radiology, 2022, vol.32
3. CE-CBBCT is concordant with surgical pathology in breast tumor size measurement. Compared with bMRI, CE-CBBCT provides more accurate tumor size estimation among invasive ductal carcinoma lesions, small size (≤2cm) lesions and premenopause patients. CE-CBBCT can be used as a valuable modality for pre-operative assessment. ------ San Antonio Breast Cancer Symposium 2022
The current studies have demonstrated at least equivalent diagnostic effectiveness between KBCT and MRI. Large-scale comparison study directly compare the sensitivity, specificity and AUC of KBCT and MRI has yet to be carried out and published.
Read Our Publications.
Read more here:
1. Siddall, K. (2022). "Exploring the Diagnostic Performance of Dedicated Cone-Beam Breast CT: Can It Be Utilized as a Substitute for Breast MRI?" SBI 2022. (https://www.eventscribe.net/2022/SBIACR2022/fsPopup.asp?efp=VlVWTERNS1kxNTM5OQ&PresentationID=1070475&rnd=0.5330223&mode=presinfo)
2. Y, M., et al. (2022). "Comparison of background parenchymal enhancement (BPE) on contrast-enhanced cone-beam breast CT (CE-CBBCT) and breast MRI." European radiology 32(8).
3. Comparison of cone beam breast CT and breast MRI in preoperative assessment of primary breast cancer tumor size
Ji Y, Liao G, Luo N, Jiang Y, Liao X, Tang W, Yang H. Guangxi Medical University Tumor Hospital. (https://www.sabcs.org/Program/Poster-Sessions/Poster-Session-3)
Koning Breast CT is intended to provide three dimensional images for diagnostic imaging of the breast.