NCT02324387

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
23mo left

Started Jun 2015

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jun 2015Mar 2028

First Submitted

Initial submission to the registry

December 11, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 24, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

June 15, 2015

Completed
12.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

12.8 years

First QC Date

December 11, 2014

Last Update Submit

March 5, 2026

Conditions

Breast Cancer

Keywords

Breast CancerMolecular breast imagingMBITc99m sestamibiNeoadjuvant chemotherapyNAC

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Molecular Breast Imaging (MBI) + Tc99m sestamibi

EXPERIMENTAL

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)Drug: Tc99m sestamibi

Interventions

Molecular Breast Imaging (MBI)PROCEDURE

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.

Also known as: MBI
Molecular Breast Imaging (MBI) + Tc99m sestamibi
Tc99m sestamibiDRUG

8 mCi of 99mTc sestamibi by vein before each molecular breast imaging (MBI).

Molecular Breast Imaging (MBI) + Tc99m sestamibi

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female of 18 years and older of any race
  • Has biopsy-proven invasive breast cancer (BI-RADS 6) and scheduled for neoadjuvant chemotherapy (NAC).
  • 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.
  • Patients with stage T1 or greater (T1-T4), nodal involvement (N0 - N3), without metastasis (M0) invasive breast cancer, including patients with inflammatory breast cancer.
  • Patients who agree to sign an informed consent to undergo MBI

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 35917778DERIVED

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Technetium Tc 99m Sestamibi

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsOrganotechnetium CompoundsOrganometallic Compounds

Study Officials

  • Gaiane M. Rauch, MD, PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2014

First Posted

December 24, 2014

Study Start

June 15, 2015

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Last Updated

March 9, 2026

Record last verified: 2026-03

Locations

US(1)