Clincosm LogoSign in Get a demo

Cone Beam Breast CT for Breast Cancer Screening

Sponsor
Koning Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05036096
Collaborator
(none)
1,024
Enrollment
2
Locations
2
Arms
12
Anticipated Duration (Months)
512
Patients Per Site
42.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: CBBCT Imaging
  • Device: Digital Mammography
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1024 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Cone Beam Breast CT for Breast Cancer Screening
Actual Study Start Date :
Oct 30, 2021
Anticipated Primary Completion Date :
Sep 29, 2022
Anticipated Study Completion Date :
Oct 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: CBBCT Imaging Screening Patients

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

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.
Experimental: CBBCT Imaging Diagnostic Patients

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

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.

Outcome Measures

Primary Outcome Measures

  1. Radiation Dose [3 months after the CBBCT imaging and Mammography imaging]

    The radiation dose of CBBCT imaging and Mammography imaging

  2. Recall Rates [3 months after CBBCT image review and Mammography image review]

    The overall recall rates of CBBCT imaging and Mammography imaging

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
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 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).

Exclusion Criteria:

  • 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

  • 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Port Orange Imaging Center Port Orange Florida United States 32129
2 Knoxville Comprehensive Breast Center Knoxville Tennessee United States 37909

Sponsors and Collaborators

  • Koning Corporation

Investigators

  • Study Director: Xiaohua Zhang, Ph.D., Koning Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Koning Corporation
ClinicalTrials.gov Identifier:
NCT05036096
Other Study ID Numbers:
  • 2021SCR
First Posted:
Sep 5, 2021
Last Update Posted:
Dec 3, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Dec 3, 2021