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:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2025-12-24 @ 9:37 PM
NCT ID:
NCT01852032
Eligibility Criteria:
Inclusion Criteria:
* 35 years of age or older
* While male patients will not be explicitly excluded, it is expected that all patients in this study will be women
* Diagnostic findings from prior mammography suspicious for, or highly suggestive of, breast malignancy -BIRADS (Breast Imaging Reporting and Data System) categories 4 and 5
* Scheduled for ultrasound or stereotactic core biopsy
* Ability to lie still on a table top for up to 10 minutes, longer than the typical breast CT duration.
* Ability to understand risks, procedures, and benefits involved
Exclusion Criteria:
* Recent breast biopsy
* History of breast augmentation implant
* Pregnant or Positive urine pregnancy test (UPT) or currently breast-feeding
* History of moderate or severe adverse reaction to iodinated contrast injection
* Recent serum creatinine ≥ 1.5 mg/dL
* History of Diabetes Mellitus
* Currently taking Glucophage or Glucovance (Metformin)
* History of chronic asthma
* History of allergy to iodine
* Multiple food and/or drug allergy
* Renal disease
* History of pulmonary disease, phobia of breath holding, or other condition that could prevent the subject from being able to perform the 16 second breath hold
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
35 Years
Study:
NCT01852032
Study Brief:
Protocol Section:
NCT01852032