Study to Demonstrate the Preliminary Safety and Effectiveness of IPBS in Performing MRI-Guided Targeting and Intervention of Breast Tissue in Female Patients Indicated for MRI-Guided Breast Biopsy

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McMaster University

Status

Completed

Conditions

Breast Cancer Screening
Breast Cancer Diagnosis
MRI Guided Breast Biopsy

Treatments

Device: IPBS

Study type

Interventional

Funder types

Other

Identifiers

NCT01885741
IPBS-001

Details and patient eligibility

About

A preliminary demonstration of the Safety of IPBS in positioning a vacuum assisted biopsy (VAB) tool to enable an MRI-guided automated breast biopsy. This will consist of 10-15 biopsy procedures facilitated by the MRI-guided system. Patients will be followed after the procedure to assess clinical outcomes.

Enrollment

9 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Female patients over the age of 18 with suspected or confirmed breast cancer requiring a manual MRI-guided breast biopsy for diagnosis and staging.
  • Individuals Capable of giving a free and informed consent.

Exclusion criteria

  • Any patient for whom the manual MRI-guided breast biopsy procedure would not be possible (size of patient, etc.).
  • Patients who refuse the procedure for any reason will be excluded from the study at the investigators discretion.
  • Patients who are not suitable for the procedure will be excluded at the investigators discretion.
  • Patients unwilling to complete associated study questionnaires or follow up visits.
  • Women who are pregnant or who plan to become pregnant within the study duration.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

9 participants in 1 patient group

IPBS
Experimental group
Treatment:
Device: IPBS

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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