Recruiting

MBI vs. MRI

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05042687

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tc99m sestamibi

Study Details

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.

Conditions

Breast Cancer

Study ID

NCT05042687

Start date

Dec 13, 2021

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Tc99m sestamibi

MBI uses an injection of a small amount of radioactive material called technetium99m (Tc99m) sestamibi

Interventions

Tc99m sestamibi

Given by IV

Primary outcome 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 [ Time Frame: through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Beatriz Adrada

(713) 792-2709beatriz.adrada@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Beatriz Adrada

713-792-2709beatriz.adrada@mdanderson.org

Principal Investigator:

Beatriz Adrada, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-04-15.