Breast CancerNCT00380952
Intraoperative Use of the BP Device for Detecting Positive Margins During Lumpectomy Procedure
A study testing Dune Device in people with Breast Cancer, run by Dune Medical Devices at 9 sites in Israel.
Trial summary
This protocol was designed for testing the intraoperative use of the Dune device. This multicenter study will take place in Israel at 12 sites. 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?
- Dune Device
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 9 sitesIsrael
- Study dates
- Nov 2006to Apr 2008
- 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
- Women diagnosed with carcinoma of the breast
- Undergoing lumpectomy (local wide excision) procedure.
- Over 18 years of age
- Signed ICF
Who cannot join
- Neoadjuvant systemic therapy
- Previous radiation in the operated breast
- Prior surgical procedure in the same quadrant
- Implants in the operated breast
- Pregnancy
- 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
9 sites in 1 country.
9 sites in 1 country
Israel9 sites
HaEmek Mc
Afula
Rambam MC
Haifa
Haddasah Medical Organization
Jerusalem
Shaare Zedek
Jerusalem
Meir MC
Kfar Saba
Rabin MC
Petah Tikva
Rivka Ziv MC
Safed
Souraski MC
Tel Aviv
Poria MC
Tiberias
About this study
Official title: MAST Study Protocol
This protocol was designed for testing the intraoperative use of the Dune device. This multicenter study will take place in Israel at 12 sites.
Read the detailed description
Use of the device will take place during a partial mastectomy procedure (lumpectomy).The patient will be randomized to enter the device or control arm.
- Conditions
- Breast Cancer
- Being tested
- Dune Device
- 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.
Dune DeviceDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2006 (estimated)
- Study startNov 2006
- Primary completionOct 2007
- Study completionApr 2008
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dune Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dan Hershko, Dr., Principal investigator, Rambam MCRona Spector, Dr., Principal investigator, Rabin MCEran Sharon, Principal investigator, Rabin MCZvi Kaufman, Dr., Principal investigator, Meir MCTal Kopelman, Dr., Principal investigator, Bnei Zion McYuri Berlin, Dr., Principal investigator, HaEmek MCMoshe Papa, Prof., Principal investigator, Sheba McTanir Allweis, Dr., Principal investigator, Haddasah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00380952
- Sponsor's protocol ID
- CP-02-001
- Status last verified
- May 2008
- First submitted
- 26 Sep 2006
- Last updated
- 28 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAST Study Protocol
- ClinicalTrials.gov ID
- NCT00380952
- Acronym / sponsor ID
- CP-02-001
- Conditions
- Breast Cancer
- Keywords
- IDC, DCIS, ILC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Dune Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 27 Sep 2006 (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.
This protocol was designed for testing the intraoperative use of the Dune device. This multicenter study will take place in Israel at 12 sites.
Detailed description
Use of the device will take place during a partial mastectomy procedure (lumpectomy).The patient will be randomized to enter the device or control arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
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)
- Women diagnosed with carcinoma of the breast
- Undergoing lumpectomy (local wide excision) procedure.
- Over 18 years of age
- Signed ICF
Key exclusion criteria (6 listed)
- Neoadjuvant systemic therapy
- Previous radiation in the operated breast
- Prior surgical procedure in the same quadrant
- Implants in the operated breast
- Pregnancy
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 |
|---|---|---|
| Dune Device | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2008.
- Official company 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.
Dan Hershko, Dr. principal investigator
Rambam MC
Rona Spector, Dr. principal investigator
Rabin MC
Eran Sharon principal investigator
Rabin MC
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dune Device in people with Breast Cancer, run by Dune Medical Devices at 9 sites in Israel.
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 6 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 28 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 28 May 2008.