A Pilot Study to Determine the Efficacy of Cryoablation for the Treatment of Invasive Breast Carcinoma Following Neoadjuvant Therapy
To perform cryoablation in this study, the doctor will insert the cryoprobe like a needle
until the tip rests in about the middle of the cancerous area. In this study, an ultrasound
imaging device will also be used to allow the doctor to see where to insert the cryoprobe.
If you are found to be eligible and agree to take part in this study, you will have an
ultrasound-guided biopsy to confirm your diagnosis. To perform an ultrasound-guided biopsy,
a tissue sample will be withdrawn from your breast using a needle and a syringe. A very
small amount of tissue will be taken. The needle is guided while being viewed by the doctor
on an ultrasound.
Before you have the cryoablation procedure, blood (about 1 teaspoon) will be drawn for
routine tests. Within 30 days after you join this study, the cryoablation procedure will be
performed. The affected area will first be numbed with anesthetic. Your study doctor will
insert the cryoprobe needle and use an ultrasound device to help guide the cryoprobe until
it reaches the cancerous area.
When in place, the cryoprobe will be used to freeze the cancerous area. The doctor will be
very careful to try to avoid damaging the surrounding normal tissue.
The cryoablation procedure will last about 20 minutes. The cryoprobe will be removed when
your doctor thinks the cancerous area has been treated as much as possible.
There will be a small wound, like a puncture wound from a large needle. Most likely, you
will not need any stitches to close this wound.
First Follow-Up Visit:
About 2-4 weeks after cryoablation:
- You will have a physical exam.
- You will have an MRI scan of the breast to check the status of the disease. This scan
is for research purposes only. Researchers want to learn if an MRI scan after
cryoablation can detect any remaining breast cancer.
Your MRI scans and the ultrasound images will be reviewed by the study radiologist. This
will include the MRI scans from before and after cryoablation, and the ultrasound images
from during cryoablation.
Within 4 weeks after cryoablation, you will have standard-of-care surgery to remove the
remaining area that was treated during cryoablation. You will be asked to sign a separate
consent form that describes the surgery in more detail.
After surgery, the doctor will also check to see if the cryoablation destroyed all of the
cancerous area. This will help researchers learn if cryoablation is effective.
Second Follow-Up Visit:
About 2 weeks after surgery:
- You will have a physical exam.
- You will be asked about any side effects you may have had from the cryoablation and
When you have finished cryoablation and surgery, you and your doctor will decide if you need
additional treatment. Additional treatment is not considered part of this study. Your
doctor will be able to answer questions you may have about additional treatment.
Length of Study Participation:
You will remain on study for about 2 months. You will be taken off study early if the
disease gets worse, if intolerable side effects occur, or if you are unable to follow study
This is an investigational study. The ultrasound-guided cryoablation system that will be
used for your cryoablation procedure has been FDA-approved for use in cancer. The use of
this system for breast cancer after chemotherapy is investigational.
Up to 10 patients will take part in this study. All will be enrolled at MD Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of Complete Ablation
Complete ablation is defined as no remaining invasive or in situ carcinoma present upon pathological examination of the targeted lesion. The rate computed as the number of patients with complete tumor ablation divided by the total number of eligible patients.
2-4 weeks after cryoablation
Rosa Hwang, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
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