Clinical trial NCT03954431: High-Resolution Lower Dose Dedicated Breast Computed Tomography (CT)
Official title: Study of High-resolution, Lower Dose Dedicated Breast CT.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2019-05-17
Enrollment: 600
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who present for breast cancer screening imaging exam, recalled after screening exam, and assigned to undergo tissue sampling (biopsy).

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.

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.

Eligibility 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.

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: 12 months after completion of accrual
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Srinivasan Vedantham, PhD
role: PRINCIPAL_INVESTIGATOR
References: