Percutaneous Excision Trial (I-PET)
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|ClinicalTrials.gov Identifier: NCT00720642|
Recruitment Status : Completed
First Posted : July 23, 2008
Last Update Posted : September 12, 2012
|Condition or disease|
|Imaged Breast Abnormalities|
|Study Type :||Observational|
|Actual Enrollment :||1170 participants|
|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.
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT00720642
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