ACTIVE_NOT_RECRUITING

Cone Beam Breast CT for Breast Cancer Screening

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Cone Beam Breast CT for Breast Cancer Screening

Quick Facts

Study Start:2021-10-30

Study Completion:2026-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05036096

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Female sex of any ethnicity * Age 40 years or older * Scheduled for a routine screening mammography exam within 4 weeks. * Female sex of any ethnicity * Age 30 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).	* 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)

Inclusion Criteria

Exclusion Criteria

* Female sex of any ethnicity
* Age 40 years or older
* Scheduled for a routine screening mammography exam within 4 weeks.
* Female sex of any ethnicity
* Age 30 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).

* 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

Principal Investigator

Xiaohua Zhang, Ph.D.

STUDY_DIRECTOR

Koning Corporation

Study Locations (Sites)

Port Orange Imaging Center

Port Orange, Florida, 32129

United States

Women's Imaging Specialists

Dacula, Georgia, 30019

United States

The Howard Center for Women's Health

Tifton, Georgia, 31794

United States

Knoxville Comprehensive Breast Center

Knoxville, Tennessee, 37909

United States

Collaborators and Investigators

Sponsor: Koning Corporation

Xiaohua Zhang, Ph.D., STUDY_DIRECTOR, Koning Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-30

Study Completion Date2026-12-30

Study Record Updates

Study Start Date2021-10-30

Study Completion Date2026-12-30

Terms related to this study

Additional Relevant MeSH Terms

Breast Cancer