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 @ 4:51 AM
Ignite Modification Date:
2025-12-25 @ 4:51 AM
NCT ID:
NCT03520218
Eligibility Criteria:
Inclusion Criteria:
* Subject is female of any race and ethnicity
* Subject is at least 26 years old
* Following routine mammography imaging, subject is categorized as BI-RADS score 4C or 5 because of calcifications, masses, asymmetries or/and architectural distortion will undergo additional tests including biopsy within 30 days of routine imaging
* Subject is female with a recent breast biopsy confirming breast cancer
Exclusion Criteria:
* Subject unable or unwilling to undergo informed consent
* Subjects who are unable or unwilling to tolerate any of the imaging tests because of claustrophobia, compression, etc.
* Subjects who are pregnant or who think they may be pregnant
* Subjects who are breast-feeding
* Subjects weight exceed table limits of MRI and PET-CT (300-450 lb or 135-205 kg)
* Subjects with history of allergic reaction to gadolinium or previous history of life-threatening anaphylactic reaction to any contrast.
* Claustrophobic subjects
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
26 Years
Study:
NCT03520218
Study Brief:
Protocol Section:
NCT03520218