Breast CancerNCT02525913
Feasibility Study of Cavity Radiofrequency Ablation in ex Vivo Mastectomy Breast Tissue
A study testing RFA Applicator in people with Breast Cancer, run by University of Arkansas at 1 site in United States.
Trial summary
The purpose of this study is to build a device that will consistently ablate (destroy or remove) cavitary breast tissue after a formal breast cancer resection in order to mimic the tissue that is now irradiated after breast cancer lumpectomy. 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?
- RFA Applicator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Sep 2016
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age greater than or equal to 18 years.
- Receiving bi-lateral mastectomy due to tumor in the breast, or by choice (prophylactic mastectomy). Only non-cancerous breast tissue will be included in the study.
- Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Those determined by the study investigator to have mental, physical, or medical conditions that would indicate that they should not participate.
- Because there is no patient contact with the device no medical contraindications are foreseen.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
The purpose of this study is to build a device that will consistently ablate (destroy or remove) cavitary breast tissue after a formal breast cancer resection in order to mimic the tissue that is now irradiated after breast cancer lumpectomy. The device would be easier to handle, perform the ablation in less time and by so ablating this margin would avoid the need in many for reoperation to obtain negative margins and based on preliminary data avoid the need for radiation. This would be especially important in poor and rural patients and would lead to decreased costs of treatment in patients with favorable breast cancer.
- Conditions
- Breast Cancer
- Being tested
- RFA Applicator
- Keywords
- Breast, Mastectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFA ApplicatorDevice
| Study group | Role | What they receive |
|---|---|---|
| Bi-lateral mastectomy | Other | Not described Receives: Device: RFA Applicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ablation Depth
Ablation depth is the extent to which tissue has been completely desiccated from the wall of the cavity. It will be assessed by pathologic analysis using H\&, PCNA, and Ki67 stains. The ablation depth of each slide processed is to be the smallest distance of completely necrotic tissue.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Why it stopped: Study was withdrawn from the IRB and never opened. No subjects were enrolled.
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.
- More trials run by University of ArkansasThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Innoblative Designs, Inc.
- Responsible party
- Sponsor
- Investigators
- Suzanne Klimberg, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525913
- Sponsor's protocol ID
- 204538
- Status last verified
- Oct 2015
- First submitted
- 13 Aug 2015
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Cavity Radiofrequency Ablation in ex Vivo Mastectomy Breast Tissue
- ClinicalTrials.gov ID
- NCT02525913
- Acronym / sponsor ID
- 204538
- Conditions
- Breast Cancer
- Keywords
- Breast, Mastectomy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was withdrawn from the IRB and never opened. No subjects were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Innoblative Designs, Inc.
- Study start
- Sep 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 18 Aug 2015 (estimated)
- 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 study is to build a device that will consistently ablate (destroy or remove) cavitary breast tissue after a formal breast cancer resection in order to mimic the tissue that is now irradiated after breast cancer lumpectomy. The device would be easier to handle, perform the ablation in less time and by so ablating this margin would avoid the need in many for reoperation to obtain negative margins and based on preliminary data avoid the need for radiation. This would be especially important in poor and rural patients and would lead to decreased costs of treatment in patients with favorable breast cancer.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bi-lateral mastectomy | Other | Device: RFA Applicator |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- Age greater than or equal to 18 years.
- Receiving bi-lateral mastectomy due to tumor in the breast, or by choice (prophylactic mastectomy). Only non-cancerous breast tissue will be included in the study.
- Ability to understand and the willingness to sign a written informed consent.
Key exclusion criteria (2 listed)
- Those determined by the study investigator to have mental, physical, or medical conditions that would indicate that they should not participate.
- Because there is no patient contact with the device no medical contraindications are foreseen.
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 |
|---|---|---|
| RFA Applicator | Device | Bi-lateral mastectomy |
Primary outcome
Ablation Depth
Time frame: One year
Ablation depth is the extent to which tissue has been completely desiccated from the wall of the cavity. It will be assessed by pathologic analysis using H\&, PCNA, and Ki67 stains. The ablation depth of each slide processed is to be the smallest distance of completely necrotic tissue.
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 12 Oct 2015.
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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.
Suzanne Klimberg, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RFA Applicator in people with Breast Cancer, run by University of Arkansas 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 4 inclusion and 2 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 12 Oct 2015. 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?
Ablation Depth (time frame: One year). 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 12 Oct 2015.