Clinical trial NCT04769960: Study of the Safety of MRI Scans in People Who Have Breast Tissue Expanders After Mastectomy
Official title: A Pilot Safety Study for Performing MRI in Patients Who Have Breast Tissue Expanders
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Breast Neoplasms
Breast Adenocarcinoma
Keywords: breast tissue expander
breast cancer
mastectomy
21-055
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC). If the investigator is a member of the treatment team, s/he will screen their patient's medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study. Potential subjects contacted by their treating physician will be referred to the investigator/research staff of the study.

Brief summary: The purpose of this study is to find out whether it is safe to perform MRI scans in people who have breast tissue expanders in place.


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.

Primary outcomes:
measure: Safety of MRI scans for patients with breast tissue expanders
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent only )
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Consent Only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Alicia Meng, MD
role: PRINCIPAL_INVESTIGATOR
References: