Breast CancerNCT04828044
Microwave Ablation of Breast Tumors
An observational study of Breast Cancer, run by St. Joseph Hospital of Orange at 1 site in United States.
Trial summary
The purpose of this protocol is to pathologically evaluate the amount of destruction of cancer cells by Microwave Ablation (MWA) in primary breast tumors. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Microwave Ablation/ Coagulation Arm
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis of primary breast tumor for which a surgical resection (excisional, biopsy, segmentectomy or mastectomy) is planned.
Who may be able to join
- a diagnosis of primary breast tumor for which a surgical resection (excisional, biopsy, segmentectomy or mastectomy) is planned.
- Tumor is palpable or visible on ultrasound or both
- All participants need to be fully able to give informed consent
Who cannot join
- Gender: male
- Mental or legal incompetence
- Impaired decision-making capacity
- Pregnant women may not participate
- Implanted Pacemaker
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Joseph Hospital of Orange
Orange, California, 92868
About this study
The purpose of this protocol is to pathologically evaluate the amount of destruction of cancer cells by Microwave Ablation (MWA) in primary breast tumors.
Read the detailed description
Minimally invasive surgical alternatives are becoming more attractive for the treatment of malignancy due to improvements in technology, reduced costs and reduced morbidity. The main objective of this protocol is to determine the extent of ablation based on time and power parameters of the MedWaves in breast cancers. This would be accomplished in patients diagnosed with breast cancer who are already scheduled for breast cancer surgery. Prior to the surgical removal of the cancer, the microwave antenna would be inserted into the tumor under ultrasound guidance (either percutaneously or open). The tumor would be ablated, and then surgically resected in a standard, curative fashion.
- Conditions
- Breast Cancer
- Being tested
- Microwave Ablation/ Coagulation Arm
- Keywords
- Breast Cancer, Tumors
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave Ablation/ Coagulation ArmDevice
Also called Medwaves Microwave Ablation/ Coagulation System
An 11-gauge microwave probe from MedWaves, Inc., will be placed in the tumor. An ablation lesion will then be generated at the appropriate power (10-35 watts) to maintain up to 130C degrees at the MW applicator tip thermocouple for 10 minutes duration. Palpation and/or ultrasound may be used to place the MWA needle and monitor the progress of the microwave ablation.
| Study group | Role | What they receive |
|---|---|---|
| Microwave Ablation/ Coagulation Arm | These patients will receive microwave ablation using MedWaves Microwave Ablation/ Coagulation System. Receives: Device: Microwave Ablation/ Coagulation Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of tissue destruction with MedWaves Microwave Ablation/ Coagulation System.
Measure tissue destruction with the MedWaves Microwave Ablation/ Coagulation System through pathological review of destruction.
Measured: 30 days
Secondary outcomes (2)
Provide the differences between percutaneous and open Microwave Ablation
Evaluate differences between percutaneous and open Microwave Ablation through pathological review and patient follow-up.
Measured: 30 Days
Amount of toxicity of microwave ablation in patients.
Measure toxicity of Microwave Ablation through patient follow-up and assessment.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study startSep 2012
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Lack of sufficient funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph Hospital of Orange
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lawrence Wagman, M.D., Principal investigator, St. Joseph Hospital of Orange
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828044
- Sponsor's protocol ID
- 12-028 MWA - Breast Tumors
- Status last verified
- Mar 2021
- First submitted
- 12 Sep 2012
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microwave Ablation of Breast Tumors
- ClinicalTrials.gov ID
- NCT04828044
- Acronym / sponsor ID
- 12-028 MWA - Breast Tumors
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Tumors
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of sufficient funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Joseph Hospital of OrangeUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this protocol is to pathologically evaluate the amount of destruction of cancer cells by Microwave Ablation (MWA) in primary breast tumors.
Detailed description
Minimally invasive surgical alternatives are becoming more attractive for the treatment of malignancy due to improvements in technology, reduced costs and reduced morbidity. The main objective of this protocol is to determine the extent of ablation based on time and power parameters of the MedWaves in breast cancers. This would be accomplished in patients diagnosed with breast cancer who are already scheduled for breast cancer surgery. Prior to the surgical removal of the cancer, the microwave antenna would be inserted into the tumor under ultrasound guidance (either percutaneously or open). The tumor would be ablated, and then surgically resected in a standard, curative fashion.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microwave Ablation/ Coagulation Arm | – | Device: Microwave Ablation/ Coagulation ArmThese patients will receive microwave ablation using MedWaves Microwave Ablation/ Coagulation System. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of primary breast tumor for which a surgical resection (excisional, biopsy, segmentectomy or mastectomy) is planned.
Key inclusion criteria (3 listed)
- a diagnosis of primary breast tumor for which a surgical resection (excisional, biopsy, segmentectomy or mastectomy) is planned.
- Tumor is palpable or visible on ultrasound or both
- All participants need to be fully able to give informed consent
Key exclusion criteria (5 listed)
- Gender: male
- Mental or legal incompetence
- Impaired decision-making capacity
- Pregnant women may not participate
- Implanted Pacemaker
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 |
|---|---|---|
| Microwave Ablation/ Coagulation ArmAlso: Medwaves Microwave Ablation/ Coagulation SystemAn 11-gauge microwave probe from MedWaves, Inc., will be placed in the tumor. An ablation lesion will then be generated at the appropriate power (10-35 watts) to maintain up to 130C degrees at the MW applicator tip thermocouple for 10 minutes duration. Palpation and/or ultrasound may be used to place the MWA needle and monitor the progress of the microwave ablation. | Device | Microwave Ablation/ Coagulation Arm |
Primary outcome
Amount of tissue destruction with MedWaves Microwave Ablation/ Coagulation System.
Time frame: 30 days
Measure tissue destruction with the MedWaves Microwave Ablation/ Coagulation System through pathological review of destruction.
2 secondary outcomes
Provide the differences between percutaneous and open Microwave Ablation
Time frame: 30 Days
Amount of toxicity of microwave ablation in patients.
Time frame: 30 Days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
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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.
Lawrence Wagman, M.D. principal investigator
St. Joseph Hospital of Orange
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by St. Joseph Hospital of Orange 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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 1 Apr 2021. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Amount of tissue destruction with MedWaves Microwave Ablation/ Coagulation System. (time frame: 30 days). 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 1 Apr 2021.