High-resolution, lower-dose dedicated breast CT

Study of High-resolution, Lower Dose Dedicated Breast CT.

This study will test whether a new dedicated breast CT scan gives clearer 3-D breast images at a lower radiation dose for women age 40 and older who are having screening, diagnostic imaging, or a biopsy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 40 Years and up
• Sex: Female
• Sponsor: University of Arizona (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Tucson, Arizona)
• Trial ID: NCT03954431 on ClinicalTrials.gov

What this trial studies

The study uses a redesigned dedicated breast CT device that acquires multiple X-ray images and reconstructs a detailed 3-D view of the breast without compression. The redesign aims to visualize smaller structures while delivering a lower radiation dose than earlier prototypes. Eligible women 40 and older who are undergoing screening, diagnostic imaging, or biopsy will undergo the investigational scan at the University of Arizona. Because the device is not FDA-approved for routine use, images are collected for research comparison with standard care.

Who should consider this trial

Good fit: Women aged 40 or older who can give informed consent, are scheduled for screening, diagnostic imaging, or biopsy, and can lie prone on the exam table within the device weight limit are ideal candidates.

Not a fit: Men, women under 40, pregnant or lactating women, those who cannot lie prone or who exceed the table weight limit, and people unable to consent are not eligible and would not benefit from participation.

Why it matters

Potential benefit: If successful, this approach could improve detection and characterization of small breast lesions while reducing radiation exposure and avoiding breast compression.

How similar studies have performed: Prior pilot studies of dedicated breast CT have shown promising image detail and lesion detection, but the technique remains investigational and is not yet standard clinical practice.

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.

Where this trial is running

Tucson, Arizona

• University of Arizona — Tucson, Arizona, United States (Recruiting)

Study contacts

• Principal investigator: Srinivasan Vedantham, PhD — University of Arizona
• Study coordinator: Michele Galvan, R.T.R.

Conditions Breast Cancer