Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT01062100
First received: February 2, 2010
Last updated: February 15, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention
Breast Cancer
 Device: nuclear breast imaging using MBI Gamma camera

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Hamilton Prospective Pilot Study To Investigate the Feasibility and Safety of A Dedicated High Resolution Nuclear Breast Imaging Camera

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ontario Clinical Oncology Group (OCOG):

Primary Outcome Measures:
  • To assess the feasibility, safety and acceptability to patients of the MBI Gamma camera. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To explore the ability of the MBI Gamma camera to detect breast cancer. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: February 2010
Study Completion Date: February 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01062100

Locations
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Investigators
Principal Investigator: Gregory Pond Ontario Clinical Oncology Group - McMaster University
Principal Investigator: Karen Gulenchyn Hamilton Health Sciences Corporation
  More Information

No publications provided

Responsible Party: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT01062100     History of Changes
Other Study ID Numbers: OCOG-2009-THORN
Study First Received: February 2, 2010
Last Updated: February 15, 2013
Health Authority: Canada: Health Canada

Keywords provided by Ontario Clinical Oncology Group (OCOG):
breast cancer
molecular breast imaging
MRI
gamma camera

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013