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NCT03954431 | NOT YET RECRUITING | Breast Cancer

High-Resolution Lower Dose Dedicated Breast Computed Tomography (CT)
Sponsor:

University of Arizona

Brief Summary:

This study is being performed to find out if a new kind of breast imaging (called dedicated breast CT or BCT) can help doctors to see the small structures in breast tissue more clearly. The investigators also want to find out if using the BCT will provide a more accurate diagnosis of breast cancer.

Condition or disease

Breast Cancer

Intervention/treatment

Dedicated breast CT(BCT)

Detailed Description:

The breast imaging device that will be used in this study (breast computed tomography or BCT) is not FDA-approved for this use so this is a research study. The machine has been redesigned to see if doctors can see smaller structures and use a lower radiation dose. The breast CT device will take multiple pictures of the subject's breast and create a 3-D image of the breast. It does not compress or squash the breast like a mammogram.

Study Type : OBSERVATIONAL
Estimated Enrollment : 600 participants
Official Title : Study of High-resolution, Lower Dose Dedicated Breast CT.
Actual Study Start Date : 2025-01
Estimated Primary Completion Date : 2028-12
Estimated Study Completion Date : 2029-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: 1
Criteria
Inclusion criteria: All subjects that are eligible to participate in the study will be women who satisfy all of the inclusion criteria stated below
  • * who are 40 years of age or older (typical screening age range)
  • * who are undergoing or scheduled for screening or diagnostic imaging, or need a biopsy to investigate an abnormality in the breast.
  • Exclusion criteria: Subjects that present with any of the criteria listed below will be excluded
    • * Males,
    • * women less than 40 years old,
    • * women unable to self-consent,
    • * prisoners,
    • * pregnant, suspected to be pregnant, or lactating women (self-reported)
    • * 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, frail, or unable to cooperate;
    • * women who weigh more than 440 lbs (200 Kg), which is the weight limit for the patient support table of the BCT system;
    • * women who have received radiation treatments to the thorax 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, and 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 number of diagnostic x-ray examinations for monitoring of disease such as (but not limited to) tuberculosis, and severe scoliosis.
High-Resolution Lower Dose Dedicated Breast Computed Tomography (CT)

Location Details

NCT03954431

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Arizona

University of Arizona

Tucson, arizona, United States, 85724