NOT_YET_RECRUITING
High-Resolution Lower Dose Dedicated Breast Computed Tomography (CT)
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.
Conditions:
🦠 Breast Cancer
🗓️ Study Start (Actual) January 2024
🗓️ Primary Completion (Estimated) December 2026
✅ Study Completion (Estimated) December 2027
👥 Enrollment (Estimated) 600
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Tucson, Arizona, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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:

    • * 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.
Ages Eligible for Study: 40 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ 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

  • First Submitted 15 May 2019
  • First Submitted that Met QC Criteria 15 May 2019
  • First Posted 17 May 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 30 August 2023
  • Last Update Posted 1 September 2023
  • Last Verified August 2023