Percutaneous Excision Trial (I-PET)

Intact Medical

Status: Completed

Conditions: Imaged Breast Abnormalities

Study type: Observational

Funder types: Industry

Identifiers

NCT00720642

Intact 06-06

Details and patient eligibility

About

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.

Enrollment: 1,170 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,170 participants in 2 patient groups

PSAP

Description:

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

Description:

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.