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 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT00584233
Eligibility Criteria:
Inclusion Criteria:
* Age at least 35 years old
* Diagnostic findings from prior mammography highly suggestive of breast malignancy (BI- RADS® category 4 or BI-RADS® category 5)
* Not pregnant or breast-feeding
* Ability to lie motionless for up to 5 minutes
Exclusion Criteria:
* Recent breast biopsy
* History of moderate or severe reaction to contrast agent injection
* History of Allergy to Iodine
* History of multiple food and/or drug allergy
* Currently taking Glucophage or Glucovance (Metformin)
* History of Chronic Asthma
* History of Diabetes Mellitus
* Renal (kidney) disease, or solitary kidney
* Recent lab tests showing elevated serum creatinine (≥ 1.5 mg/dL)
* Recent lab tests showing estimated glomerular filtration rate (eGFR) ≤ 60 ml/minute
* Positive urine pregnancy test or currently breast-feeding
* Inability to understand the risks and benefits of the study
* The standard MRI contraindications apply, including but not limited to: having a pacemaker or other implanted electronic device, metal foreign bodies within the eye, aneurysm clips, heart valve prosthesis, vascular stents, coils, intrauterine devices (IUDs), inferior vena cava (IVC) filters, gunshot wounds with retained bullet fragments.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
35 Years
Study:
NCT00584233
Study Brief:
Protocol Section:
NCT00584233