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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT01773551
Eligibility Criteria:
Treatment Group Inclusion Requirements
1. Premenopausal or peri-menopausal female older than 21 years of age
2. Elect to undergo, but have not yet started tamoxifen therapy;
3. Not pregnant and willing to use adequate contraception for the duration of study participation; and
4. Willing to avoid oral contraception use (which is not recommended while on tamoxifen treatment) for the duration of the study participation.
Normal Group Inclusion Requirements
1. Premenopausal or peri-menopausal female older than 21 years of age
2. Not pregnant and willing to use adequate contraception for the duration of study participation;
Exclusion (both groups) Requirements
1. Had or plan to receive any chemotherapy;
2. Have bilateral breast cancer
3. Previous treatment (chemotherapy, radiation, or surgery) to both breasts, including hormone therapy;
4. Are pregnant or nursing;
5. Have implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical clips (hemostatic clips) or other metallic implants;
6. Have engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or have imbedded metal fragments from military activities;
7. Have received orthodontic work involving ferromagnetic materials;
8. Are claustrophobic; or
9. Medically unstable.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
50 Years
Study:
NCT01773551
Study Brief:
Protocol Section:
NCT01773551