No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 and older
Sex
Female
Study type
Interventional
Purpose
Diagnostic
Participants needed
600 (estimated)
Sponsor
University of Arizona · Other
Who this trial is looking for
This trial is looking for women who are 40 years or older and are getting breast imaging or need a biopsy due to an abnormality. Participants will undergo a new type of breast imaging to help doctors see small structures more clearly.
Are You a Good Fit for This Trial?
You may be able to join if
I am 40 years old or older
I am undergoing or scheduled for breast imaging
I need a biopsy to check an abnormality in my breast
You may not be able to join if
I am a man
I am under 40 years old
I cannot consent for myself
I am currently pregnant or breastfeeding
I have physical limitations preventing me from lying down for the exam
I weigh more than 440 lbs
I have received radiation treatment to my chest
I have participated in another breast trial with extra radiation
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Status
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 biop…
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.
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