Study of the Safety of MRI Scans in People Who Have Breast Tissue Expanders After Mastectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-19

Study Completion Date

2026-02-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer Breast Neoplasms Breast Adenocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with breast tissue expanders

Participants with breast tissue expanders that require an MRI for clinical purposes are eligible for this study.

MRI Studies

Intervention Type DIAGNOSTIC_TEST

MRI scans will be performed on a 1.5T MRI scanner. Department of Radiology MRI SafetyGuidelines will be followed except regarding breast tissue expanders. Conventional MRIstudies will be performed using the standard of care clinical sequences.

Patient Reported Outcomes

Intervention Type BEHAVIORAL

Participants will fill out questionnaires before, immediately after, and approximately 3 months following the MRI examination +/- 1 month to evaluate for any pain or perceived changes with the breast tissue expander. The first questionnaire will obtain background participants information as well as establish a baseline pain level, the second questionnaire will evaluate any changes in pain after undergoing the MRI examination, and the last questionnaire will evaluate long term changes in pain. The patient reported outcome questionnaire will be optional at 3 months post-MRI +/-1 month.

Interventions

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MRI Studies

MRI scans will be performed on a 1.5T MRI scanner. Department of Radiology MRI SafetyGuidelines will be followed except regarding breast tissue expanders. Conventional MRIstudies will be performed using the standard of care clinical sequences.

Intervention Type DIAGNOSTIC_TEST

Patient Reported Outcomes

Participants will fill out questionnaires before, immediately after, and approximately 3 months following the MRI examination +/- 1 month to evaluate for any pain or perceived changes with the breast tissue expander. The first questionnaire will obtain background participants information as well as establish a baseline pain level, the second questionnaire will evaluate any changes in pain after undergoing the MRI examination, and the last questionnaire will evaluate long term changes in pain. The patient reported outcome questionnaire will be optional at 3 months post-MRI +/-1 month.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes