Percutaneous Excision Trial (I-PET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00720642
Recruitment Status : Completed
First Posted : July 23, 2008
Last Update Posted : September 12, 2012
Information provided by (Responsible Party):
Intact Medical Corporation

Brief Summary:
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.

Condition or disease
Imaged Breast Abnormalities

Study Type : Observational
Actual Enrollment : 1170 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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.
Study Start Date : July 2006
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

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.
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.

Primary Outcome Measures :
  1. The proportion of patients in various populations who undergo an Intact procedure with an upgrade in the diagnosis after undergoing an open surgical excision. [ Time Frame: Post Intact Excision ]

Biospecimen Retention:   Samples Without DNA
Breast lesion tissue

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00720642

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Sponsors and Collaborators
Intact Medical Corporation

Responsible Party: Intact Medical Corporation Identifier: NCT00720642     History of Changes
Other Study ID Numbers: Intact 06-06
First Posted: July 23, 2008    Key Record Dates
Last Update Posted: September 12, 2012
Last Verified: September 2012