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:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2025-12-26 @ 12:14 PM
NCT ID:
NCT01062100
Eligibility Criteria:
Inclusion Criteria:
* Females ≥18 years of age
* Undergoing annual breast MRI because of a high risk of breast cancer due to any of the following:
* Known BRCA1 or BRCA2 mutation carriers, or is untested for BRCA but is a first degree relative of a BRCA mutation carrier
* History of radiation to the chest between 10-30 years of age (e.g. Hodgkin's Disease)
* History of Cowdens or Li Fraumeni Syndrome
* A first degree relative with Cowdens or Li Fraumeni Syndrome
* Prior breast biopsy positive for lobular carcinoma in situ (LCIS) or atypical lobular hyperplasia or atypical ductal hyperplasia (ADH)
* Family history consistent with a hereditary breast cancer syndrome and estimated personal lifetime cancer risk ≥25% using the IBIS risk evaluator
Exclusion Criteria:
* Pregnant or lactating
* History of invasive breast cancer or ductal carcinoma in situ (DCIS)
* Unable to undergo MRI because of:
* Renal dysfunction with an estimated creatinine clearance of \< 30 ml/min calculated using the Cockcroft-Gault formula
* Implanted ferrous metal prostheses
* Claustrophobia
* Medical or psychological conditions that on assessment, make them unable to complete the procedure
* Known allergies to Gadolinium-DTPA
* Known allergies to Sestamibi (Miraluma or Cardiolite)
* Prior bilateral mastectomy
* Prior breast biopsy or surgery within 3 months
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01062100
Study Brief:
Protocol Section:
NCT01062100