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Imaging Techniques for Breast Cancer

Phase < 1

Waitlist Available

Led By Gaiane M Rauch

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The patient has proven TNBC, defined by standard pathologic assays as negative for estrogen receptor (ER) and progesterone receptor (PR) (< 10% tumor staining) and negative for human epidermal growth factor 2 (HER2) (immunohistochemistry [IHC] score < 3, gene copy number not amplified)

TNBC patients who are previously untreated and enrolled in the prospective Institutional Review Board (IRB) approved clinical trial: 2014-0185

Must not have

Has lesions involving chest wall

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial uses DCE-MRI and technetium-Tc99m sestamibi molecular breast imaging (MBI) to assess tumor response to chemotherapy in patients with triple negative breast cancer (TNBC).

Who is the study for?

This trial is for individuals who can consent to participate, have confirmed triple negative breast cancer (TNBC) with no prior treatment, and are enrolled in the clinical trial: 2014-0185. It's not for those with MRI contraindications, pregnant or nursing women, patients with chest wall-involved lesions, allergies to Tc99m sestamibi, or issues with MRI contrast.

What is being tested?

The study is testing how well DCE-MRI and MBI imaging techniques measure the effectiveness of chemotherapy in TNBC patients. These advanced scans might help predict patient response to treatment before it's visible through standard methods.

What are the potential side effects?

While this trial focuses on imaging techniques rather than drugs, potential side effects may include discomfort during the scan procedure, allergic reactions to dyes used in DCE-MRI or MBI (rare), and anxiety from being in a confined space during MRI.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My breast cancer is triple-negative, not showing positive for estrogen, progesterone, or HER2.

Select...

I have triple-negative breast cancer and haven't started treatment yet.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My cancer has spread to my chest wall.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent change in tumor volume assessed by dynamic Tc99m-sestamibi MBI

Neoplasms

Tumor response assessed by pathological examination

Other study objectives

Utility of molecular breast imaging (MBI) and dynamic contrast enhanced molecular resonance imaging (DCE-MRI) together with molecular profiling to identify a subgroup of chemoresistant triple negative breast cancer (TNBC) patients

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (DCE-MRI, MBI)Experimental Treatment4 Interventions

Patients undergo DCE-MRI over 45-60 minutes. Patients receive technetium Tc-99m sestamibi via injection, and after 5 minutes patients undergo MBI scan over 1 hour. Both DCE-MRI and MBI are performed at the time of enrollment, at the end of anthracycline therapy, and at the conclusion of NAC before surgery. All patients also undergo standard of care imaging with DM and US (at the same time points if the treating doctor chooses to do so).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

2006

Completed Phase 2

~310

0 / 3Eligibility criteria met