Percutaneous Excision Trial (I-PET)

Percutaneous Excision Trial (I-Pet): A Multi-Center Clinical Study Of The Intact Breast Lesion Excision System (Bles) To Demonstrate That A Definitive Diagnosis Can Be Made From The Tissue Sample Collected With The Intact Bles.

To confirm that a definitive diagnosis can be made from the tissue sample collected using the Intact BLES when defined radiology and pathology criteria are met.

Study Overview

• Status: Completed
• Conditions: Imaged Breast Abnormalities

• Study Type: Observational
• Enrollment (Actual): 1170

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas For Medical Services
  • California
    • Indio, California, United States, 92201
      • The Breast Health Center
    • Long Beach, California, United States, 90806
      • Long Beach Memorial Breast Center
    • Pasadena, California, United States, 91105
      • The Hill Breast Center
  • Florida
    • St. Augustine, Florida, United States, 32086
      • Flagler Hospital
    • West Palm Beach, Florida, United States, 33407
      • Center for Breast Care HCA
  • Georgia
    • Lithonia, Georgia, United States, 30058
      • Metro Surgical Associates, Inc.
    • Tifton, Georgia, United States, 31793
      • TIFT Regionald Medical Center
  • Hawaii
    • Wailuku, Hawaii, United States, 96793
      • Maui Medical Group
  • Kansas
    • Overland Park, Kansas, United States, 66204
      • Shawnee Mission Medical Center
  • Maryland
    • Towson, Maryland, United States, 21204
      • St. Joseph Medical Center
  • Massachusetts
    • Springfield, Massachusetts, United States, 01102
      • Mercy Medical Center
  • Michigan
    • Grand Blanc, Michigan, United States, 48439
      • Genesys Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Cancer Institute
  • New York
    • Binghamton, New York, United States, 13905
      • Lourdes Hospital Breast Center
    • Johnson City, New York, United States, 13790
      • Wilson Hospital Breast Center
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Jewish Hospital Breast Center
    • Cincinnati, Ohio, United States, 45267-0772
      • University of Cincinnati The Barrett Center
    • Elyria, Ohio, United States, 44035
      • Elyria Memorial Hospital
    • Westlake, Ohio, United States, 44145
      • St. John West Shore Hospital
  • Pennsylvania
    • Lewisburg, Pennsylvania, United States, 17837
      • Evangelical Hospital
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
  • South Carolina
    • Murrells Inlet, South Carolina, United States, 29576
      • Coastal Carolina Breast Center
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • Nashville Breast Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients with an imaged breast abnormality found with mammography or sonography whose initial biopsy will be taken with the Intact BLES.

Description

Inclusion Criteria:

• Patient must be a female at least 18 years of age at the time of Intact BLES biopsy
• Patient must have had an imaged abnormality found via mammography or sonography that warrants a biopsy for further diagnosis

Exclusion Criteria:

• Patients who have pre-pectoral breast implants
• Patients who have implantable devices such as pacemakers and defibrillators
• Patients who are pregnant or lactating
• Patients in whom the device is contraindicated
• Patients who are contraindicated for surgery due to factors such as anti-coagulant use which cannot be safely reversed or who exhibit fever or other clinical evidence of infection

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
PSAP; This is the population of patients in whom surgical intervention could possibly be avoided. These patients will be those in whom all imaging evidence (mammographic or sonographic) was removed during the Intact BLES procedure, and in whom a definitive diagnosis of ADH could be made using the pathology assessment criteria outlined in the protocol.
NPSAP; Patients with a pathology diagnosis of ADH in whom all imaging evidence (mammographic or sonographic) of the target lesion was NOT removed OR in whom a definitive diagnosis of ADH COULD NOT be made by implementing the pathology criteria for evaluation outlined in the protocol AND patients with a diagnosis of DCIS will undergo open surgical excision and will be analyzed separately from the PSAP group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of patients in various populations who undergo an Intact procedure with an upgrade in the diagnosis after undergoing an open surgical excision.	Post Intact Excision

Collaborators and Investigators

• Sponsor: Intact Medical Corporation

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (ACTUAL): June 1, 2011
• Study Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: July 21, 2008
• First Submitted That Met QC Criteria: July 22, 2008
• First Posted (ESTIMATE): July 23, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): September 12, 2012
• Last Update Submitted That Met QC Criteria: September 11, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: Intact 06-06