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Comparing MBI and MRI for High-Risk Breast Cancer Screening

This study is comparing two imaging tests, Molecular Breast Imaging (MBI) using Tc99m sestamibi (a special dye given through an IV), and Magnetic Resonance Imaging (MRI) of the breast. The goal is to see how well each test finds or rules out breast cancer in women who have a high risk of getting the disease. Researchers want to understand which test performs better. You may be able to join if you are a woman aged 18 or older with a high risk for breast cancer, such as having a calculated lifetime risk over 20% or certain genetic mutations. The main way they will measure success is by comparing the diagnostic performance of MBI to MRI over about one year. The current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment or intervention. It aims to enroll 300 women.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through study completion, which is an average of 1 year.

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NCT05042687

Comparative Performance of Molecular Breast Imaging (MBI) to Magnetic Resonance Imaging (MRI) of the Breast in Identifying and Excluding Breast Carcinoma in Women at High Risk for Breast Cancer

Recruiting
NAAges 18+InterventionalDiagnostic
M.D. Anderson Cancer Center
~300 participants
Updated 2026-04-15 on ClinicalTrials.gov
What's tested:Tc99m sestamibi

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To establish the diagnostic performance of Molecular Breast Imaging (MBI) to breast Magnetic Resonance Imaging (MRI) in women who are at high risk of developing breast cancer
Measured over through study completion, an average of 1 year

Conditions

Breast Cancer

Explore related trials

Breast CarcinomaGenetic mutation

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Beatriz Adrada · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Beatriz Adrada
[email protected]
(713) 792-2709
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

The subjects to be studied will include female patients ages 18 and older of any race, identified as carrying an elevated risk for breast cancer referred to MDACC.
High risk may be defined as having a calculated lifetime risk \>20%, histopathology of lobular neoplasia or atypical ductal hyperplasia, atypia NOS or a genetic mutation known to predispose the patient to breast cancer.
Subject who are scheduled for a Breast MRI who are willing to participate fully in all aspects of the study including completing both a Breast MRI \& MBI screening exam within a two-week time window, a biopsy of any positive findings and complete a post examination survey. Consent for the enrollment may be obtained upon scheduling the MRI examination. For non-English speakers, a language interpreter will assist in translation.
Written consent will be obtained from all participants to obtain MBI of the breasts and biopsy as indicated, based on findings. All participants will be asked to provide a post examination survey of their experience with both tests.

Exclusion

Subjects who are pregnant will be excluded as MBI exam involves injection of radioactive tracer
contrast enhanced MRI involves gadolinium injection, both of which are contraindicated during pregnancy.

What this trial measures

  • To establish the diagnostic performance of Molecular Breast Imaging (MBI) to breast Magnetic Resonance Imaging (MRI) in women who are at high risk of developing breast cancerthrough study completion, an average of 1 year