Study To Investigate the Feasibility and Safety of A Dedicated High Resolution Nuclear Breast Imaging Camera (THORN)

February 15, 2013 updated by: Ontario Clinical Oncology Group (OCOG)

The Hamilton Prospective Pilot Study To Investigate the Feasibility and Safety of A Dedicated High Resolution Nuclear Breast Imaging Camera

To evaluate the feasibility, acceptability and safety of using a molecular breast imaging (MBI) Gamma Camera in women at high risk of developing breast cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • Juravinski Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Females ≥18 years of age

  • Undergoing annual breast MRI because of a high risk of breast cancer due to any of the following:

    • Known BRCA1 or BRCA2 mutation carriers, or is untested for BRCA but is a first degree relative of a BRCA mutation carrier
    • History of radiation to the chest between 10-30 years of age (e.g. Hodgkin's Disease)
    • History of Cowdens or Li Fraumeni Syndrome
    • A first degree relative with Cowdens or Li Fraumeni Syndrome
    • Prior breast biopsy positive for lobular carcinoma in situ (LCIS) or atypical lobular hyperplasia or atypical ductal hyperplasia (ADH)
    • Family history consistent with a hereditary breast cancer syndrome and estimated personal lifetime cancer risk ≥25% using the IBIS risk evaluator

Exclusion Criteria:

  • Pregnant or lactating
  • History of invasive breast cancer or ductal carcinoma in situ (DCIS)

  • Unable to undergo MRI because of:

    • Renal dysfunction with an estimated creatinine clearance of < 30 ml/min calculated using the Cockcroft-Gault formula
    • Implanted ferrous metal prostheses
    • Claustrophobia
    • Medical or psychological conditions that on assessment, make them unable to complete the procedure
    • Known allergies to Gadolinium-DTPA
  • Known allergies to Sestamibi (Miraluma or Cardiolite)
  • Prior bilateral mastectomy
  • Prior breast biopsy or surgery within 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: nuclear breast imaging
nuclear breast imaging using MBI Gamma camera
Device: nuclear breast imaging using MBI Gamma camera
nuclear breast imaging using MBI Gamma camera in addition to MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the feasibility, safety and acceptability to patients of the MBI Gamma camera.
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
To explore the ability of the MBI Gamma camera to detect breast cancer.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ontario Clinical Oncology Group (OCOG)

Investigators

  • Principal Investigator: Gregory Pond, Ontario Clinical Oncology Group - McMaster University
  • Principal Investigator: Karen Gulenchyn, Hamilton Health Sciences Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

February 2, 2010

First Submitted That Met QC Criteria

February 3, 2010

First Posted (Estimate)

February 4, 2010

Study Record Updates

Last Update Posted (Estimate)

February 18, 2013

Last Update Submitted That Met QC Criteria

February 15, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCOG-2009-THORN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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