Intraoperative Use of the BP Device for Detecting Positive Margins During Lumpectomy Procedure
MAST Study Protocol
1 other identifier
interventional
300
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Nov 2006
Shorter than P25 for not_applicable breast-cancer
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2006
CompletedFirst Posted
Study publicly available on registry
September 27, 2006
CompletedStudy Start
First participant enrolled
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedMay 28, 2008
May 1, 2008
11 months
September 26, 2006
May 25, 2008
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Women diagnosed with carcinoma of the breast
- Undergoing lumpectomy (local wide excision) procedure.
- Over 18 years of age
- Signed ICF
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
HaEmek Mc
Afula, Israel
Rambam MC
Haifa, Israel
Haddasah Medical Organization
Jerusalem, Israel
Shaare Zedek
Jerusalem, Israel
Meir MC
Kfar Saba, Israel
Rabin MC
Petah Tikva, Israel
Rivka Ziv MC
Safed, Israel
Souraski MC
Tel Aviv, Israel
Poria MC
Tiberias, Israel
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dan Hershko, Dr.
Rambam MC
- PRINCIPAL INVESTIGATOR
Rona Spector, Dr.
Rabin MC
- PRINCIPAL INVESTIGATOR
Eran Sharon
Rabin MC
- PRINCIPAL INVESTIGATOR
Zvi Kaufman, Dr.
Meir MC
- PRINCIPAL INVESTIGATOR
Tal Kopelman, Dr.
Bnei Zion Mc
- PRINCIPAL INVESTIGATOR
Yuri Berlin, Dr.
HaEmek MC
- PRINCIPAL INVESTIGATOR
Moshe Papa, Prof.
Sheba Mc
- PRINCIPAL INVESTIGATOR
Tanir Allweis, Dr.
Haddasah Medical Organization
- PRINCIPAL INVESTIGATOR
Shlomo Schneebaum, Prof.
Souraski MC
- PRINCIPAL INVESTIGATOR
Moshe Carmon, Dr.
Shaare Zedek MC
- PRINCIPAL INVESTIGATOR
Amram Adari, Dr.
Ziv Mc
- PRINCIPAL INVESTIGATOR
Moshe Zilberman, Dr.
Poria MC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 26, 2006
First Posted
September 27, 2006
Study Start
November 1, 2006
Primary Completion
October 1, 2007
Study Completion
April 1, 2008
Last Updated
May 28, 2008
Record last verified: 2008-05