Multimodality Breast Imaging for the Assessment of Tumor Response to Neoadjuvant Chemotherapy in Triple Negative Breast Cancer Patients



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/8/2018
Start Date:November 2016
End Date:November 2020
Contact:Gaiane M. Rauch, MD, PHD
Phone:713-745-5768

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The goal of this clinical research study is to learn if investigational imaging scans can
help researchers predict which patients may respond to treatment. The results of these
investigational scans will be compared to the results of standard digital mammograms (DMs)
and ultrasound (US).

The investigational imaging scans being used on this study are:

- Tc99m Sestamibi Molecular Breast Imaging (MBI), and

- Dynamic Contrast Enhanced Molecular Resonance Imaging (DCE-MRI).

If you agree to take part in this study, you will be receiving an anthracycline regimen or
anthracycline neoadjuvant-based therapies, depending on what the treating physician thinks is
in your best interest.

In addition to the tests and procedures described in the consent for study 2014-0185, you
will have DCE-MRIs and MBI scans at 3 different time points. These will be performed at:

- Before you start anthracycline regimen therapy

- When you finish receiving anthracycline regimen therapy

- When you finish receiving neoadjuvant therapy before surgery

Before each DCE-MRI , you will be given contrast injection by vein. Each DCE-MRI will take 45
minutes to an hour total, and is performed like a normal MRI.

Before each MBI scan, you will receive an injection of 99mTc sestamibi (a type of drug that
gives off energy that is seen with special cameras, like a mammogram). You will have an MBI
scan about 5 minutes after you receive Tc99m sestamibi. During the scan, your breast will be
positioned between 2 detectors and lightly compressed. The detectors are 2 square cameras,
which look very similar to mammogram cameras. You are seated during the entire procedure and
the scan should take about an hour.

During the first part of this imaging study, the MBI scans for the first 5-10 patients may be
about 20 minutes longer than normal, and the MRI scans will take about 10 minutes longer than
normal. These scans may take longer because the study staff will be adjusting the machines
for this study.

If the doctor thinks it is needed to check the status of the disease (as part of your
standard of care), you will also have digital mammography and ultrasound at the same 3 time
points. You will receive the results of the mammography and ultrasound.

Information, such as images from previous scans and your medical history, will also be
collected from your medical record.

The results from the DCE-MRI and MBI scans will not affect or change your course of
treatment, including the type of surgery you may have. You and your treating physician will
receive the results of the MBI and DCE/MRI but the results will not be used for treatment
planning.

Length of Study:

Your participation on this study will be over once you complete your surgery. If you are
unable to have one of the investigational scans due to intolerable side effects, you will be
taken off study early.

This is an investigational study. DCE-MRIs of the breast and MBI scans on this study are
performed using FDA-approved and commercially available methods. Tc99m sestamibi is
FDA-approved and commercially available. The use of MRI and MBI scans for TNBC is considered
investigational.

Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.

Inclusion Criteria:

1. The patient has proven TNBC, defined by standard pathologic assays as negative for ER
and PR (<10% tumor staining) and negative for HER2 (IHC score <3, gene copy number not
amplified).

2. TNBC patients who are previously untreated and enrolled in the prospective IRB
approved clinical trial: 2014-0185.

3. Patient >/= 18 years of age.

4. Patients who are able to understand and give consent to participation in the study.

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.

5. Has known contraindications to MRI.

6. Has contraindication to MRI contrast.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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mi
from
Houston, TX
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