Tc99m Sestamibi Molecular Breast Imaging
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/12/2019 |
| Start Date: | June 2015 |
| End Date: | June 2019 |
| Contact: | Gaiane M. Rauch, MD, PHD |
| Phone: | 713-745-5768 |
Assessment of the Tumor Response to Neoadjuvant Chemotherapy in Women With Locoregional Invasive Breast Cancer Using Tc99m Sestamibi Molecular Breast Imaging: A Prospective Study
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.
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.
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.
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.
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
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
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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