Clinical Trials Logo
  1. Home
  2. Breast Cancer
  3. NCT01885741
  4. Details
NCT01885741 Clinical Trial

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

Breast Cancer Screening Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01885741
Other study ID # IPBS-001
Secondary ID
Status Completed
Phase N/A
First received June 19, 2013
Last updated April 17, 2017
Start date September 2013
Est. completion date May 2014

Study information
Verified date April 2017
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 9
Est. completion date May 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• IPBS

Locations
Country Name City State
Canada St. Joseph's Healthcare Hamilton Hamilton Ontario
Canada Hopital du Saint-Sacrement Quebec City Quebec

Sponsors (1)
Lead Sponsor Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency of target reached by the interventional tools as determined by a qualified physician reviewing the MR images. Day 1
See also
  Status Clinical Trial Phase
Completed NCT04601272 - Evaluating the Shared Decision Making Process Scale in Cancer Screening Decisions
Completed NCT03979729 - Breast Cancer Screening for Underserved Women: Comparing Outcomes and Lowering Recall Rates With 3D- vs. 2D-mammography
Completed NCT02198690 - Trial of a Mammography Decision Aid for Women Aged 75 and Older N/A
Completed NCT01267110 - Engaging Diverse Underserved Communities to Bridge the Mammography Divide N/A
Completed NCT00287040 - Breast Cancer Screening Via Computer V. Phone Phase 3
Recruiting NCT05268224 - A Tear-based, Lab-developed Test for Breast Cancer for Women With Dense Breast Tissue
Recruiting NCT06098118 - Adapting a Mammography Decision Aid to Support Women Living in a Community Contaminated by PFAS N/A
Completed NCT05821023 - Messaging Strategies to Reduce Breast Cancer Over-screening in Older Women N/A
Recruiting NCT05841355 - Empowering Latinas to Obtain Guideline Concordant Screenings N/A
Recruiting NCT05960188 - Project 1: Self-Triage by 2D Full-field Digital Mammography or Synthetic Images N/A
Recruiting NCT04429269 - A Comparative Study of Mammography and Ultrasound for Breast Cancer Screening and Early Diagnosis
Active, not recruiting NCT03377036 - Breast Cancer Screening: Digital Breast Tomosynthesis Versus Digital 2D Mammography N/A
Completed NCT05756725 - Improving Cancer Screening and Follow-up in Community Health Centers N/A
Enrolling by invitation NCT06059300 - Digital Breast Tomosynthesis for the Dutch National Breast Cancer Screening Program N/A
Completed NCT03046004 - Effect of Information About the Benefits and Harms of Mammography on Women's Decision Making N/A
Completed NCT03517813 - CESM ABMR Breast Cancer Screening Trial
Completed NCT02273206 - Collaborative Care to Reduce Depression and Increase Cancer Screening Among Low-Income Urban Women N/A
Completed NCT00224224 - A Comparison of Primary Care and Traditional Internal Medicine Residents N/A
Recruiting NCT04102722 - Safety and Performance of the Multi-Modal UltraSound Tomography (MUST) Device in Breast Cancer Screening N/A
Completed NCT04259866 - FALSE POSITIVE FINDINGS IN BREAST CANCER TOMOSYNTHESIS