A Phase 2 interventional study of Visica 2™ Treatment System and Cryoablation in Breast Cancer, sponsored by M.D. Anderson Cancer Center. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-17.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
Cryoablation is a procedure that uses a hollow, thin tube called a cryoprobe to freeze and destroy cancer tissue.
The goal of this clinical research study is to learn about the level of effectiveness of using ultrasound-guided cryoablation in patients with invasive breast cancer. The safety of this procedure will also be studied.
Study Procedure:
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 To perform an ultrasound-guided biopsy, a tissue sample will be withdrawn from your breast using a needle and a syringe.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.
Cryoablation:
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:
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.
Surgery:
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:
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 directions.
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 1 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cryoablation therapy followed by re-imaging then complete surgical resection.
Device: Visica 2™ Treatment System · Procedure: Cryoablation · Procedure: Surgical Resection
The Visica 2™ Treatment System uses a closed system to circulate liquid nitrogen within the probe tip creating sub-freezing temperatures that result in precision cryoablation of the intended target tissue.
Cryoablation procedure uses a hollow, thin tube called a cryoprobe to freeze and destroy cancer tissue. The cryoprobe needle insertion is done using ultrasound guide to reach target, procedure lasts about 20 minutes.
Complete surgical resection of the primary tumor following cryoablation therapy.
Also known as: Surgery
Rate of Complete Tumor Ablation
The rate of complete tumor ablation in the target lesion will be evaluated by pathologic review of the surgical specimen.
Time frame: From cryoablation through 30 days from surgery
Ten participants are required for analysis. Patients over 18, with invasive ductal carcinoma with less than or equal to 2 cm residual disease after neoadjuvant treatment, among other criteria are eligible.
| Milestone | All Participants Enrolled and Started Treatment |
|---|---|
| Started | 1 |
| Cryoablation | 1 |
| Completed | 1 |
| Not completed | 0 |
The rate of complete tumor ablation in the target lesion will be evaluated by pathologic review of the surgical specimen.
| Participants | All Participants Enrolled and Started Treatment |
|---|---|
| Rate of Complete Tumor Ablation | 0 |
Collected over From cryoablation through 30 days from surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Participants Enrolled and Started Treatment | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
Overall number of baseline participants does not differ from the number of participants assigned to the arms/overall.
| Age, Categorical(Participants) | All Participants Enrolled and Started Treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | All Participants Enrolled and Started Treatment |
|---|---|
| Female | 1 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | All Participants Enrolled and Started Treatment |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | All Participants Enrolled and Started Treatment |
|---|---|
| United States | 1 |
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This study is terminated, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center