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Completed

NCT Number: NCT01885741

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

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.

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Key information

Conditions

Breast Cancer Screening Breast Cancer Diagnosis Breast Diseases Breast Neoplasms MRI Guided Breast Biopsy Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IPBS

Device

Primary outcomes

  1. Frequency of target reached by the interventional tools as determined by a qualified physician reviewing the MR images.

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

A Prospective, Open-Label, Single-Arm, Single-Site, 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.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 25, 2013
Registry last updated
Apr 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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