Feasibility Study of MRI in Evaluation of Cardiovascular Parameters and Residual Breast Tissue in Transmasculine Patients

Overview

About this study

The purpose of this study is to determine the feasibility of CMR for detecting and characterizing any potential effects of exogenous, testosterone-based gender-affirming hormone therapy (GAHT) on cardiac anatomy and function in transmasculine persons (men, nonbinary, and other gender expansive people whose sex was recorded female at birth). These parameters will be compared to 1:1 age-matched Mayo Clinic archival cisgender men and women.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

    • Subjects should be >18 years of age;
    • Assigned female at birth;
    • Healthy and not under treatment for existing cardiovascular diseases (heart failure, cardiomyopathy, myocardial infarction, uncontrolled hypertension, hypertrophic cardiomyopathy, familial dyslipidemia, or congenital heart diseases);
    • With or without oophorectomy;
    • Subjects must be receiving testosterone-based GAHT for > 2 years and >12 months from chest masculinization surgery.
    • Review of renal function prior to the MRI administration of contrast material.

Exclusion Criteria: 

    • Persons who are not deemed safe to enter the MRI (metal, claustrophobia, etc). Patients may be eligible to receive an anxiolytic medication for claustrophobia. In this case, they would be eligible to receive the scan.;
    • Persons with allergy to other contraindication to receiving gadolinium-based contrast material;
    • Known cardiomyopathy, infiltrative or depositional disorder (hemochromatosis, glycogen storage disease, Anderson-Fabry),
    • Previous myocardial infarction or myocardial surgery

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 07/22/2024. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Justin Stowell, M.D.

Open for enrollment

Contact information:

Justin Stowell M.D.

(904) 956-1997

Stowell.Justin@mayo.edu

More information

Publications

Publications are currently not available