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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014