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 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 12:02 AM
NCT ID:
NCT00058058
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Recently confirmed unilateral ductal carcinoma in situ or invasive cancer of the breast
* Confirmed by biopsy or fine needle aspiration (FNA) within the past 60 days
* Negative or benign mammogram (BI-RADS assessment 1 or 2) and negative or benign clinical breast exam of the contralateral breast within the past 90 days
* Prior biopsy of the contralateral breast (including FNA) is allowed provided it was performed at least 6 months prior to study entry
* Prior magnetic resonance exam of the contralateral breast is allowed provided it was performed at least 1 year prior to study entry
* No remote history of breast cancer
* No new breast symptoms within the past 60 days for which further evaluation is recommended
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Female
Menopausal status
* Not specified
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Cardiovascular
* No pacemaker
* No magnetic aneurysm clips
Other
* Not pregnant
* No implanted magnetic device
* No severe claustrophobia
* No other contraindications to MRI
* No psychiatric, psychological, or other condition that would preclude informed consent
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* At least 6 months since prior anticancer chemotherapy
Endocrine therapy
* No concurrent therapeutic hormonal therapy, tamoxifen, or aromatase inhibitors (preventive therapy allowed)
Radiotherapy
* Not specified
Surgery
* Not specified
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00058058
Study Brief:
Protocol Section:
NCT00058058