Intraoperative Use of the BP Device for Detecting Positive Margins During Lumpectomy Procedure

MAST Study Protocol

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00380952

Enrollment

300

Registered

2006-09-27

Start date

2006-11-30

Completion date

2008-04-30

Last updated

2008-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

IDC, DCIS, ILC

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.

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.

Interventions

DEVICEDune Device

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Women diagnosed with carcinoma of the breast 2. Undergoing lumpectomy (local wide excision) procedure. 3. Over 18 years of age 4. Signed ICF

Exclusion criteria

1. Neoadjuvant systemic therapy 2. Previous radiation in the operated breast 3. Prior surgical procedure in the same quadrant 4. Implants in the operated breast 5. Pregnancy 6. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026