Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the diagnostic performance of Tc99m sestamibi (MBI) compared to breast MRI in women who are at high risk for developing breast cancer.

To assess the relationship of tumor size, histologic subtype and location of lesion and how it affects lesion conspicuity and sensitivity in MBI detected cancers.

Detailed description: Primary Objective:

-To compare 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.

Secondary Objectives:

* To evaluate the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of MBI compared to breast MRI in women who are at high risk of developing breast cancer.
* To assess patient preference for the two examinations by conducting a post examination survey and follow up questionnaire (see addendum).
* To assess the relationship of tumor size, histologic subtype and location of lesion with lesion conspicuity (mild, moderate, marked uptake compared to background activity) according to MBI lexicon \[1\].

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.

Primary outcomes:
measure: 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
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Beatriz Adrada
role: PRINCIPAL_INVESTIGATOR
References: