Breast CancerPivotalNCT00749931
MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery
A study testing MarginProbe and Lumpectomy in people with Breast Cancer, run by Dune Medical Devices at 21 sites in 2 countries.
Trial summary
The purpose of this study is to show that addition of device use to a routine breast cancer tumor excision procedure is beneficial and assists the surgeon in correctly determining the extent of excision. 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?
- MarginProbe and Lumpectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 664 participants
- Where
- 21 sitesin 2 countries
- Study dates
- Oct 2008to Jun 2010
- Phase
- Interventional
- 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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women histologically diagnosed with carcinoma of the breast
- Women with non-palpable malignant lesions, requiring image guided localization.
- Undergoing lumpectomy (partial mastectomy) procedure.
- Age 18 years or more
- Signed ICF
Who cannot join
- Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast)
- Bilateral disease (diagnosed cancer in both breasts)
- Neoadjuvant systemic therapy
- Previous radiation in the operated breast
- Prior surgical procedure in the same breast
- Implants in the operated breast
Show all 9Show fewer
- Pregnancy
- Lactation
- Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States18 sites
Breast Care Center
Allentown, Pennsylvania, 18104
Anne Arundel Medical Center
Annapolis, Maryland, 21401
Virginia Hospital Center
Arlington, Virginia, 22205
Mercy Hospital Services
Baltimore, Maryland, 21202
Franklin Square Hospital Center
Baltimore, Maryland, 21237
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
Pacific Breast Care
Costa Mesa, California, 92627
University of Southern California
Los Angeles, California, 90033
Cedars Sinai Hospital
Los Angeles, California, 90048
Beth Israel Medical Center
New York, New York, 10003
NYU Clinical Cancer Center
New York, New York, 10016
St. Luke's Roosevelt
New York, New York, 10019
Weill Medical College of Cornell University
New York, New York, 10021
Columbia University Medical Center
New York, New York, 10032
HOAG Memorial Hospital
Newport Beach, California, 92658-6100
St. Joseph Hospital
Orange, California, 92868
UCIrvine Medical Center
Orange, California, 92868
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Israel3 sites
Haddasah Medical Organization
Jerusalem
Shaare Zedek
Jerusalem
Assaf Harofeh Medical Center
Zrifin, 70300
About this study
The purpose of this study is to show that addition of device use to a routine breast cancer tumor excision procedure is beneficial and assists the surgeon in correctly determining the extent of excision.
Read the detailed description
The study is a prospective, multi-center, randomized, double arm study demonstrating the effectiveness of the device in adjunctive use for locating the tissue for additional excision following primary specimen excision. One arm is a "Standard of Care" (SOC) Control group and the other arm a "Device+SOC" group.In the "Device +SOC" group the surgeon will use the MarginProbe device on the tissue specimen removed during the surgical procedure.The surgeon will use the results derived from the device and other routine assessments to decide if it is necessary to remove some additional breast tissue.
- Conditions
- Breast Cancer
- Being tested
- MarginProbe, Lumpectomy
- Keywords
- IDC, DCIS, ILC
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MarginProbeDevice
Device use to assess margin status of the excised specimen surface.
LumpectomyProcedure or surgery
Standard of care lumpectomy procedure
| Study group | Role | What they receive |
|---|---|---|
| SOC | Active comparator | Standard of Care arm - standard of care lumpectomy procedure Receives: Procedure: Lumpectomy |
| Device + SOC | Experimental | Use of the device in addition to the standard of care lumpectomy procedure. Receives: Device: MarginProbe; Procedure: Lumpectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Effectiveness Endpoint is a Measure of Intraoperative Success in Addressing Positive Margins as Detected by Permanent Pathology)by Additional Oriented Tissue Re-excision From the Surgical Cavity.
Tests the efficacy of the device to intra-operatively assess positive margins (superiority) - CSR is 'positive' when all positive margins, as detected by histology, on the main specimen addressed intra-operatively
Measured: two weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionMar 2010
- Study completionJun 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 664 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dune Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tanir M. Allweis, MD, Principal investigator, Hadassah Medical Organization, IsraelMoshe Carmon, MD, Principal investigator, Shaare Zedek Medical Center, IsraelTami Karni, MD, Principal investigator, Assaf Harefeh Medical Center, IsraelAlison Estabrook, MD, Principal investigator, St. Luke's Roosevelt, NY, USAFreya Schnabel, MD, Principal investigator, NYU Clinical Cancer Center, NY, USARache M. Simmons, MD, Principal investigator, Weill Medical College of Cornell University, NY, USASheldon M. Feldman, MD, Principal investigator, Columbia University Medical Center, NY, USAMark A. Gittelman, MD, Principal investigator, Breast Care Specialist, Allentown, Pennsylvania, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749931
- Sponsor's protocol ID
- CP-03-001
- Acronym
- Pivotal
- Status last verified
- May 2014
- First submitted
- 7 Sep 2008
- Last updated
- 27 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Schnabel F, Boolbol SK, Gittleman M, Karni T, Tafra L, Feldman S, Police A, Friedman NB, Karlan S, Holmes D, Willey SC, Carmon M, Fernandez K, Akbari S, Harness J, Guerra L, Frazier T, Lane K, Simmons RM, Estabrook A, Allweis T. A randomized prospective study of lumpectomy margin assessment with use of MarginProbe in patients with nonpalpable breast malignancies. Ann Surg Oncol. 2014 May;21(5):1589-95. doi: 10.1245/s10434-014-3602-0. Epub 2014 Mar 5.
PubMed 24595800
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery
- ClinicalTrials.gov ID
- NCT00749931
- Acronym / sponsor ID
- Pivotal / CP-03-001
- Conditions
- Breast Cancer
- Keywords
- IDC, DCIS, ILC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 664 participants (actual)
- Lead sponsor
- Dune Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 9 Sep 2008 (estimated)
- Results
- Posted 27 Jun 2014
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 show that addition of device use to a routine breast cancer tumor excision procedure is beneficial and assists the surgeon in correctly determining the extent of excision.
Detailed description
The study is a prospective, multi-center, randomized, double arm study demonstrating the effectiveness of the device in adjunctive use for locating the tissue for additional excision following primary specimen excision. One arm is a "Standard of Care" (SOC) Control group and the other arm a "Device+SOC" group.In the "Device +SOC" group the surgeon will use the MarginProbe device on the tissue specimen removed during the surgical procedure.The surgeon will use the results derived from the device and other routine assessments to decide if it is necessary to remove some additional breast tissue.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOC | Active comparator | Procedure: LumpectomyStandard of Care arm - standard of care lumpectomy procedure |
| Device + SOC | Experimental | Device: MarginProbe, Procedure: LumpectomyUse of the device in addition to the standard of care lumpectomy procedure. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women histologically diagnosed with carcinoma of the breast
- Women with non-palpable malignant lesions, requiring image guided localization.
- Undergoing lumpectomy (partial mastectomy) procedure.
- Age 18 years or more
- Signed ICF
Key exclusion criteria (9 listed)
- Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast)
- Bilateral disease (diagnosed cancer in both breasts)
- Neoadjuvant systemic therapy
- Previous radiation in the operated breast
- Prior surgical procedure in the same breast
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 |
|---|---|---|
| MarginProbeDevice use to assess margin status of the excised specimen surface. | Device | Device + SOC |
| LumpectomyStandard of care lumpectomy procedure | Procedure or surgery | Device + SOC, SOC |
Primary outcome
The Primary Effectiveness Endpoint is a Measure of Intraoperative Success in Addressing Positive Margins as Detected by Permanent Pathology)by Additional Oriented Tissue Re-excision From the Surgical Cavity.
Time frame: two weeks after surgery
Tests the efficacy of the device to intra-operatively assess positive margins (superiority) - CSR is 'positive' when all positive margins, as detected by histology, on the main specimen addressed intra-operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24595800Schnabel F, Boolbol SK, Gittleman M, Karni T, Tafra L, Feldman S, Police A, Friedman NB, Karlan S, Holmes D, Willey SC, Carmon M, Fernandez K, Akbari S, Harness J, Guerra L, Frazier T, Lane K, Simmons RM, Estabrook A, Allweis T. A randomized prospective study of lumpectomy margin assessment with use of MarginProbe in patients with nonpalpable breast malignancies. Ann Surg Oncol. 2014 May;21(5):1589-95. doi: 10.1245/s10434-014-3602-0. Epub 2014 Mar 5.
- Dune Medical Devices official web siteLink 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.
Tanir M. Allweis, MD principal investigator
Hadassah Medical Organization, Israel
Moshe Carmon, MD principal investigator
Shaare Zedek Medical Center, Israel
Tami Karni, MD principal investigator
Assaf Harefeh Medical Center, Israel
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MarginProbe and Lumpectomy in people with Breast Cancer, run by Dune Medical Devices at 21 sites in 2 countries.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Israel. 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?
Yes. Results are posted in the registry (first posted 27 Jun 2014). 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?
The Primary Effectiveness Endpoint is a Measure of Intraoperative Success in Addressing Positive Margins as Detected by Permanent Pathology)by Additional Oriented Tissue Re-excision From the Surgical Cavity. (time frame: two weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00749931, which also lists 1 linked publication.
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 27 Jun 2014.