Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT01107860
Eligibility Criteria:
Inclusion Criteria:
Group I:
* Females at least 35 years of age of any ethnicity
* Had a mammogram, read as BI-RADS® 1 or 2
* Will undergo study imaging no later than four weeks from date of mammogram.
* Is able to undergo informed consent.
Group II:
* Females at least 35 years of age of any ethnicity
* Require diagnostic imaging
* Will undergo study imaging no later than four weeks from date of diagnostic mammogram
* Is able to undergo informed consent
Exclusion Criteria:
Group I and Group II:
* Pregnancy
* Lactation
* Subjects 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.
* Subjects who are unable to tolerate study constraints.
* Subjects 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
* Treatment for Hodgkins disease
* Subjects who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
* Subjects who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)
* Tuberculosis
* Severe scoliosis
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
35 Years
Study:
NCT01107860
Study Brief:
Protocol Section:
NCT01107860