Comparing Molecular Breast Imaging and MRI for Breast Cancer Detection in High-Risk Women

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

This study is testing if a new type of breast imaging called Molecular Breast Imaging works better than MRI for spotting breast cancer in women who are at high risk.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT05042687 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of Molecular Breast Imaging (MBI) using Tc99m sestamibi compared to traditional breast Magnetic Resonance Imaging (MRI) in women at high risk for breast cancer. The primary goal is to assess the diagnostic performance of MBI in identifying and excluding breast carcinoma. Secondary objectives include measuring the sensitivity, specificity, and predictive values of both imaging techniques, as well as understanding patient preferences through surveys. The study also aims to explore how tumor characteristics affect the visibility and detection rates of cancers identified by MBI.

Who should consider this trial

Good fit: Ideal candidates are female patients aged 18 and older with a calculated lifetime risk of breast cancer greater than 20% or specific histopathological findings.

Not a fit: Patients who do not meet the high-risk criteria for breast cancer or those who are not scheduled for a breast MRI may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic accuracy for breast cancer in high-risk women, potentially allowing for earlier detection and better treatment outcomes.

How similar studies have performed: Other studies have shown promising results in using MBI for breast cancer detection, suggesting that this approach may be effective, though this specific comparison with MRI is less commonly tested.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Houston, Texas

• M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Beatriz Adrada — M.D. Anderson Cancer Center
• Study coordinator: Beatriz Adrada

Conditions Breast Cancer