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 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT04769960
Eligibility Criteria:
Patients with breast tissue expanders that require an MRI for clinical purposes are eligible for this study. Patients must provide an implant card or surgical report indicated the exact make and model of their implanted tissue expander. Breast tissue expanders marked as "MRI unsafe" will be allowed with exceptions as described in the Participant exclusion criteria. While all types of MRI will be included in this study, including breast MRI, we anticipate that most of the MRI examinations ordered will evaluate the brain or spine for detecting or following metastasis.
Inclusion Criteria:
* Patient ≥ 18 years old on day of signing informed consent
* Has a breast tissue expander implanted \> 28 days ago
* Patients must provide an implant card or surgical report indicated the exact make and model of their implanted tissue expander
Exclusion Criteria:
* Patients with AeroForm Tissue Expanders (manufactured by AirXpanders)
* Anyone who would normally be excluded from undergoing an MRI examination as per the Memorial Hospital for Cancer and Allied Diseases screening policy in the MRI Safety Policy (https://one.mskcc.org/sites/pub/ehs/Policies/ECSE-2009.pdf), aside from having a breast tissue expander
* Patients who are reportedly pregnant, who have a positive urine or serum pregnancy test at the time of imaging, or for which pregnancy cannot be ruled out.
* Patients who are unable to tolerate, comply or complete the MRI exam due to claustrophobia, anxiety, known psychiatric or substance abuse disorder, age, frailty, or medical instability.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04769960
Study Brief:
Protocol Section:
NCT04769960