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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Tc99m sestamibi

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].

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hannah L Chung; Phone Number: (713) 745-4555; Email: hlchung@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Hannah L Chung; Phone Number: 713-745-4555; Email: hlchung@mdanderson.org
      • Principal Investigator: Hannah L Chung, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tc99m sestamibi; MBI uses an injection of a small amount of radioactive material called technetium99m (Tc99m) sestamibi	Drug: Tc99m sestamibi; Given by IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Hannah L Chung, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: September 8, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Technetium Tc 99m Sestamibi
• Other Study ID Numbers: 2020-0927; NCI-2021-09605 (Other Identifier: NCI CTRP Clinical Trials Registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No