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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

February 2, 2010
February 15, 2013
February 2010
September 2012   (final data collection date for primary outcome measure)
To assess the feasibility, safety and acceptability to patients of the MBI Gamma camera. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01062100 on ClinicalTrials.gov Archive Site
To explore the ability of the MBI Gamma camera to detect breast cancer. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study To Investigate the Feasibility and Safety of A Dedicated High Resolution Nuclear Breast Imaging Camera
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
Not Provided
Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Breast Cancer
Device: nuclear breast imaging using MBI Gamma camera
nuclear breast imaging using MBI Gamma camera in addition to MRI
Experimental: nuclear breast imaging
nuclear breast imaging using MBI Gamma camera
Intervention: Device: nuclear breast imaging using MBI Gamma camera
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
February 2013
September 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01062100
OCOG-2009-THORN
No
Ontario Clinical Oncology Group (OCOG)
Ontario Clinical Oncology Group (OCOG)
Not Provided
Principal Investigator: Gregory Pond Ontario Clinical Oncology Group - McMaster University
Principal Investigator: Karen Gulenchyn Hamilton Health Sciences Corporation
Ontario Clinical Oncology Group (OCOG)
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP