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

Status: Active

Description

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.

Eligibility Criteria

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

Locations & Contacts

Texas

Conroe
MD Anderson in The Woodlands
Status: Active
Contact: Gaiane M. Rauch
Phone: 713-745-5768
Houston
M D Anderson Cancer Center
Status: Active
Contact: Gaiane M. Rauch
Phone: 713-745-5768
MD Anderson West Houston
Status: Active
Contact: Gaiane M. Rauch
Phone: 713-745-5768
Memorial Hermann Memorial City Medical Center
Status: Active
Contact: Gaiane M. Rauch
Phone: 713-745-5768
League City
MD Anderson League City
Status: Active
Contact: Gaiane M. Rauch
Phone: 713-745-5768
Sugar Land
MD Anderson in Sugar Land
Status: Active
Contact: Gaiane M. Rauch
Phone: 713-745-5768

Trial Objectives and Outline

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).

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Diagnostic

Lead Organization

Lead Organization
M D Anderson Cancer Center

Principal Investigator
Gaiane M. Rauch

Trial IDs

Primary ID 2015-0816
Secondary IDs NCI-2016-00715
Clinicaltrials.gov ID NCT02744053