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 @ 5:06 PM
Ignite Modification Date:
2025-12-24 @ 5:06 PM
NCT ID:
NCT02009150
Eligibility Criteria:
Inclusion Criteria:
* Female
* Woman has read, understood and signed the inform consent form
* Age: 20 years and older
* Women who are asymptomatic for breast cancer
* Proven carriers of deleterious BRCA1 or BRCA2 mutations Or Women that were found to have a lifetime risk of developing breast cancer greater or equal to 20% based on Tyrer-Cuzick, Gail or Clause risk models
* Women scheduled to undergo routine mammography and/or US or MRI screening
Exclusion Criteria:
* Women who have had a mammography and/or ultrasound examination performed on the day of the study prior to MIRA scan
* Women who had a lumpectomy surgery
* Women who had undergone mastectomy and/or reconstruction
* Women who have undergone any type of breast surgery throughout the 6 months preceding the study
* Women who have had a breast biopsy performed throughout the 10 weeks preceding the study.
* Women who have a fever on the day of the MIRA imaging
* Women who are pregnant
* Women who are breast-feeding
* Women who had undergone breast reduction/augmentation
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
20 Years
Study:
NCT02009150
Study Brief:
Protocol Section:
NCT02009150