Breast CancerPhase 2NCT01388777
Cryoablation for Invasive Breast Carcinoma Following Neoadjuvant Therapy
A Phase 2 study testing Visica 2™ Treatment System, Cryoablation and Surgical Resection in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Visica 2™ Treatment System, Cryoablation and Surgical Resection
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2012to 14 Jun 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unifocal primary invasive ductal breast carcinoma diagnosed by core needle biopsy. NOTE: Patients with lobular carcinoma, multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or ductal carcinoma in situ (DCIS) with microinvasion are NOT eligible. Patients with contralateral disease will remain eligible.
- Neoadjuvant chemotherapy or hormonal therapy for the index tumor is required.
- Residual tumor size </= 2.0 cm in greatest diameter. Specifically, the tumor must measure </= 2.0 cm in the axis parallel to the treatment probe and </= 1.5 cm in the axis anti-parallel to the treatment probe. Largest size measured by mammogram, ultrasound or MRI will be used to determine eligibility.
- Tumor enhancement on pre-registration MRI.
- Tumor with <25% intraductal components in the aggregate.
- Adequate breast size for safe cryoablation. Male breast cancer patients and female breast cancer patients with breasts too small to allow safe cryoablation are not eligible as the minimal thickness of the breast tissue does not lend itself to cryoablation.
- Patients with prior in-situ or invasive breast carcinomas are eligible if the prior carcinomas occurred in the contralateral breast. Patients with prior in-situ or invasive carcinomas of the ipsilateral breast are not eligible.
Who cannot join
- History of open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer. Note: Prior rotational and/or vacuum-assisted core biopsies are permitted if no significant distortion is seen on imaging that could obscure visualization and detection of residual disease on MRI, or visualization of cancer on ultrasound for cryoablation procedure.
- Pregnant and/or lactating. Patients of childbearing potential must have a negative serum or urine pregnancy test. NOTE: Peri-menopausal women must be amenorrheic for > 12 months to be considered not of childbearing potential.
- Patient has contra-indication to an MRI examination, such as clips/prostheses/implants that are not MRI compatible, or compromised renal function, with a measured or calculated glomerular filtration rate of 60ml/min/1.73m^2
- Patients less than 18 years of age will not be included in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Pilot Study to Determine the Efficacy of Cryoablation for the Treatment of Invasive Breast Carcinoma Following Neoadjuvant Therapy
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.
Read the detailed description
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:
- 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.
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:
- You will have a physical exam.
- You will be asked about any side effects you may have had from the cryoablation and 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.
- Conditions
- Breast Cancer
- Being tested
- Visica 2™ Treatment System, Cryoablation, Surgical Resection
- Keywords
- Breast Cancer, Breast Carcinoma, Cryoablation, The Visica 2™ Treatment System, Unifocal primary invasive ductal breast carcinoma, Cryoprobe
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visica 2™ Treatment SystemDevice
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.
CryoablationProcedure or surgery
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.
Surgical ResectionProcedure or surgery
Also called Surgery
Complete surgical resection of the primary tumor following cryoablation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation | Experimental | Cryoablation therapy followed by re-imaging then complete surgical resection. Receives: Device: Visica 2™ Treatment System; Procedure: Cryoablation; Procedure: Surgical Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From cryoablation through 30 days from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2011 (estimated)
- Study start24 Jan 2012
- Primary completion14 Jun 2017
- Study completion14 Jun 2017
Why it stopped: Early termination leading to small number of subjects analyzed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- To determine the rate of complete tumor ablation in patients treated with cryoablation, with complete tumor ablation defined as no remaining invasive or in situ carcinoma present upon pathological examination of the targeted lesion.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosa Hwang, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388777
- Sponsor's protocol ID
- 2010-0986
- Other IDs
- NCI-2011-01278
- Status last verified
- Jun 2018
- First submitted
- 5 Jul 2011
- Last updated
- 17 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine the Efficacy of Cryoablation for the Treatment of Invasive Breast Carcinoma Following Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT01388777
- Acronym / sponsor ID
- 2010-0986
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Breast Carcinoma, Cryoablation, The Visica 2™ Treatment System, Unifocal primary invasive ductal breast carcinoma, Cryoprobe
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early termination leading to small number of subjects analyzed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 24 Jan 2012 (actual)
- Primary completion
- 14 Jun 2017 (actual)
- Study completion
- 14 Jun 2017 (actual)
- First posted
- 7 Jul 2011 (estimated)
- Results
- Posted 17 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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.
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:
- You will have a physical exam.
- You will be asked about any side effects you may have had from the cryoablation and 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To determine the rate of complete tumor ablation in patients treated with cryoablation, with complete tumor ablation defined as no remaining invasive or in situ carcinoma present upon pathological examination of the targeted lesion.
| Arm | Type | Receives |
|---|---|---|
| Cryoablation | Experimental | Device: Visica 2™ Treatment System, Procedure: Cryoablation, Procedure: Surgical ResectionCryoablation therapy followed by re-imaging then complete surgical resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Unifocal primary invasive ductal breast carcinoma diagnosed by core needle biopsy. NOTE: Patients with lobular carcinoma, multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or ductal carcinoma in situ (DCIS) with microinvasion are NOT eligible. Patients with contralateral disease will remain eligible.
- Neoadjuvant chemotherapy or hormonal therapy for the index tumor is required.
- Residual tumor size </= 2.0 cm in greatest diameter. Specifically, the tumor must measure </= 2.0 cm in the axis parallel to the treatment probe and </= 1.5 cm in the axis anti-parallel to the treatment probe. Largest size measured by mammogram, ultrasound or MRI will be used to determine eligibility.
- Tumor enhancement on pre-registration MRI.
- Tumor with <25% intraductal components in the aggregate.
Key exclusion criteria (4 listed)
- History of open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer. Note: Prior rotational and/or vacuum-assisted core biopsies are permitted if no significant distortion is seen on imaging that could obscure visualization and detection of residual disease on MRI, or visualization of cancer on ultrasound for cryoablation procedure.
- Pregnant and/or lactating. Patients of childbearing potential must have a negative serum or urine pregnancy test. NOTE: Peri-menopausal women must be amenorrheic for > 12 months to be considered not of childbearing potential.
- Patient has contra-indication to an MRI examination, such as clips/prostheses/implants that are not MRI compatible, or compromised renal function, with a measured or calculated glomerular filtration rate of 60ml/min/1.73m^2
- Patients less than 18 years of age will not be included in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visica 2™ Treatment SystemThe 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. | Device | Cryoablation |
| CryoablationCryoablation 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. | Procedure or surgery | Cryoablation |
| Surgical ResectionAlso: SurgeryComplete surgical resection of the primary tumor following cryoablation therapy. | Procedure or surgery | Cryoablation |
Primary outcome
Rate of Complete Tumor Ablation
Time frame: From cryoablation through 30 days from surgery
The rate of complete tumor ablation in the target lesion will be evaluated by pathologic review of the surgical specimen.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa Hwang, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Visica 2™ Treatment System, Cryoablation and Surgical Resection in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Complete Tumor Ablation (time frame: From cryoablation through 30 days from surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.