DCE-MRI and MBI in Assessing Tumor Response to Chemotherapy in Patients With Triple Negative Breast Cancer

  • STATUS
    Recruiting
  • days left to enroll
    63
  • participants needed
    100
  • sponsor
    M.D. Anderson Cancer Center
Updated on 22 January 2021
cancer
estrogen
breast cancer
growth factor
progesterone
immunohistochemistry
HER2
biomarker analysis
human epidermal growth factor
triple negative breast cancer
progesterone receptor
erbb2
epidermal growth factor
estrogen receptor

Summary

This early phase I trial studies how well dynamic contrast enhanced molecular resonance imaging (DCE-MRI) and technetium-Tc99m sestamibi molecular breast imaging (MBI) work in assessing tumor response to chemotherapy in patients with triple negative breast cancer (TNBC) who are undergoing chemotherapy. Investigational imaging scans such as MBI and DCE-MRI may help researchers predict which patients may respond to treatment.

Description

PRIMARY OBJECTIVES:

I. To determine the predictive value of advanced imaging modalities Tc99m sestamibi (technetium Tc-99m sestamibi) molecular breast imaging (MBI) and dynamic contrast enhanced (DCE) magnetic resonance imaging (MRI) for neoadjuvant chemotherapy (NAC) response in triple negative breast cancer (TNBC).

SECONDARY OBJECTIVES:

I. To evaluate and compare the ability all imaging modalities including standard of care digital mammogram (DM) and ultrasound (US) as well as novel modalities DCE-MRI and MBI to assess and predict response to neoadjuvant chemotherapy (NAC) in patients with triple negative breast cancer (TNBC).

EXPLORATORY OBJECTIVES:

I. To determine effect of molecular subtype of TNBC on diagnostic performance of different types of imaging modalities in predicting treatment response.

II. To determine the Utility of Dynamic Tc99m sestamibi MBI and DCE-MRI together with molecular profiling to identify a subgroup of chemoresistant TNBC patients.

OUTLINE

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).

Details
Condition Breast Cancer, Estrogen Receptor Negative, Progesterone Receptor Negative, HER2/Neu Negative, Triple-Negative Breast Carcinoma, HER2/Neu Negative, Triple-Negative Breast Carcinoma, Triple Negative Breast Carcinoma, HER2/Neu Negative
Treatment laboratory biomarker analysis, dynamic contrast-enhanced magnetic resonance imaging, Dynamic Contrast Enhanced Molecular Resonance Imaging (DCE-MRI), Tc99m Sestamibi Molecular Breast Imaging (MBI), 99mTc Sestamibi, 99mTc Sestamibi, Scintimammography, Technetium Tc-99m Sestamibi
Clinical Study IdentifierNCT02744053
SponsorM.D. Anderson Cancer Center
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Patients who are able to understand and give consent to participating in the study

Exclusion Criteria

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
Has known contraindications to MRI
Has contraindication to MRI contrast
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