Tc99m Sestamibi Molecular Breast Imaging

Assessment of the Tumor Response to Neoadjuvant Chemotherapy in Women With Locoregional Invasive Breast Cancer Using Tc99m Sestamibi Molecular Breast Imaging: A Prospective Study

This clinical trial studies technetium Tc-99m sestamibi molecular breast imaging in predicting tumor response in patients with locoregional breast cancer that has spread from where it began in the breast to surrounding normal tissue who are receiving neoadjuvant chemotherapy. Comparing results of diagnostic procedures, such as technetium Tc-99m sestamibi molecular breast imaging, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Molecular Breast Imaging (MBI); Drug: Tc99m sestamibi

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate the ability of technetium Tc-99m sestamibi (Tc 99m sestamibi) molecular breast imaging (MBI) to predict early response to neoadjuvant chemotherapy (NAC) and to assess residual disease at the completion of NAC in patients with locoregional invasive breast cancer.

SECONDARY OBJECTIVES:

I. To evaluate and qualitatively characterize Tc 99m sestamibi uptake by tumor on MBI at the baseline, after 2 cycles of NAC and at the completion of NAC.

II. To compare assessment of tumor response to NAC by MBI with digital mammography (DM), and breast ultrasound (US) exams.

III. To compare tumor size and distribution observed from MBI at the completion of NAC with extent of residual disease at surgery by pathological evaluation.

IV. To develop image acquisition and processing algorithm that quantifies the Tc 99m tumor uptake.

EXPLORATORY OBJECTIVE:

I. To determine effect of molecular subtype of cancer (Her2+, ER/PR/Her2- and ER+/Her2-) on diagnostic performance of MBI in predicting treatment response.

OUTLINE:

Patients undergo technetium Tc-99m sestamibi molecular breast imaging over 45 minutes at baseline (before start of NAC), after 2 courses of NAC (6-12 weeks, depending on the regimen), and the completion of NAC but before surgery. Patients also undergo breast ultrasound and mammographic imaging as standard of care at the same time points.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Female of 18 years and older of any race
2. Has biopsy-proven invasive breast cancer (BI-RADS 6) and scheduled for neoadjuvant chemotherapy (NAC).
3. Newly diagnosed biopsy proven locoregional invasive breast cancer at MD Anderson Cancer Center, or referred to MD Anderson for treatment after initial radiologic (mammographic, sonographic, etc.) exams at an outside institution in whom NAC is planned.
4. Patients with stage T1 or greater (T1-T4), nodal involvement (N0 - N3), without metastasis (M0) invasive breast cancer, including patients with inflammatory breast cancer.
5. Patients who agree to sign an informed consent to undergo MBI

Exclusion Criteria:

1. Is under 18 years of age
2. Is pregnant (confirmed by the patient as Imaging Clinic standard of care) or nursing mother
3. Has lesions involving chest wall
4. Has known allergy to Tc99m sestamibi

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: Molecular Breast Imaging (MBI) + Tc99m sestamibi; Participants undergo 3 MBI scans with injections of injection of Tc99m sestamibi before each scan. First scan is 7 days before scheduled chemotherapy treatment, after 2 cycles of chemotherapy, and after completion of chemotherapy treatment.

Procedure: Molecular Breast Imaging (MBI); Participants undergo 3 MBI scans with injections of injection of Tc99m sestamibi before each scan. First scan is 7 days before scheduled neoadjuvant chemotherapy (NAC) treatment, after 2 cycles of chemotherapy, and after completion of chemotherapy treatment.; Other Names: MBI; Drug: Tc99m sestamibi; 8 mCi of 99mTc sestamibi by vein before each molecular breast imaging (MBI).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of Treatment Response using Molecular Breast Imaging (MBI) plus Tc99m sestamibi	Evaluation of treatment response by molecular breast imaging (MBI) tumor to background ratio (T/B), defined as T/B = ROIt_max/ROIb_mean, calculated.	24 weeks

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Gaiane M. Rauch, MD, PHD, M.D. Anderson Cancer Center

Publications and helpful links

General Publications

• Lopez BP, Rauch GM, Adrada B, Kappadath SC. Functional tumor diameter measurement with molecular breast imaging: development and clinical application. Biomed Phys Eng Express. 2022 Aug 12;8(5). doi: 10.1088/2057-1976/ac85f0.

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2015
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: December 11, 2014
• First Submitted That Met QC Criteria: December 18, 2014
• First Posted (Estimated): December 24, 2014

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Breast Cancer; Neoadjuvant chemotherapy; MBI; NAC; Molecular breast imaging; Tc99m sestamibi
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Organic Chemicals; Nitriles; Organotechnetium Compounds; Organometallic Compounds; Technetium Tc 99m Sestamibi
• Other Study ID Numbers: 2014-0812; NCI-2015-00035 (Registry Identifier: NCI CTRP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes