NCT01885741

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

April 19, 2017

Status Verified

April 1, 2017

Enrollment Period

6 months

First QC Date

June 19, 2013

Last Update Submit

April 17, 2017

Conditions

Breast Cancer ScreeningMRI Guided Breast BiopsyBreast Cancer Diagnosis

Outcome Measures

Primary Outcomes (1)

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

    Day 1

Study Arms (1)

IPBS

EXPERIMENTAL
Device: IPBS

Interventions

IPBSDEVICE
IPBS

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Hopital du Saint-Sacrement

Québec, Quebec, G1S 4L8, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2013

First Posted

June 25, 2013

Study Start

September 1, 2013

Primary Completion

March 1, 2014

Study Completion

May 1, 2014

Last Updated

April 19, 2017

Record last verified: 2017-04

Locations

CA(2)