Houston, Texas 77030


Purpose:

The goal of this clinical research study is to compare Tc99m sestamibi molecular breast imaging (MBI) scans to mammograms and ultrasounds (the current standard of care) to learn if MBI scans can measure if the disease is responding to chemotherapy.


Study summary:

If you are found to be eligible to take part in this study and you agree, you will have a total of 3 MBI scans: before you start your already scheduled chemotherapy treatment, after 2 cycles of chemotherapy, and after you complete your chemotherapy treatment but before surgery. You will also receive your standard of care scans. Before each MBI scan, you will receive an injection of Tc99m sestamibi (a type of drug that gives off energy that is seen with special cameras, like the MBI scan, which creates images of the breast). 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 mammography cameras. The scan should take about 40 minutes. Information, such as images from previous scans and your medical history, will also be collected from your medical record. The results from the MBI scans will not affect or change your treatment, including the type of surgery you may have. Length of Study: Your active participation on this study will be over after the last MBI scan is completed. This is an investigational study. 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 MBI scans to measure how much cancer is in the breast during chemotherapy is considered investigational. Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.


Criteria:

Inclusion Criteria: 1. Female of 18 years and older of any race 2. Has biopsy-proven invasive breast cancer (BI-RADS 6) and scheduled for neoadjuvant chemotherapy (NAC). 3. 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. 4. Patients with stage T1 or greater (T1-T4), nodal involvement (N0 - N3), without metastasis (M0) invasive breast cancer, including patients with inflammatory breast cancer. 5. Patients who agree to sign an informed consent to undergo MBI 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


NCT ID:

NCT02324387


Primary Contact:

Principal Investigator
Gaiane M. Rauch, MD, PHD
M.D. Anderson Cancer Center

Gaiane M. Rauch, MD, PHD
Phone: 713-745-5768
Email: GMRauch@mdanderson.org


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.