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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: nuclear breast imaging using MBI Gamma camera

• Registration Number: NCT01062100
• Lead Sponsor: Ontario Clinical Oncology Group (OCOG)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-02
• Study First Submitted QC: 2010-02-03
• Study First Posted: 2010-02-04
• Primary Completion: 2012-09
• Status Verified: 2013-02
• Study Completion: 2013-02
• Last Update Submitted: 2013-02-15
• Last Update Posted: 2013-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nuclear breast imaging	nuclear breast imaging using MBI Gamma camera	nuclear breast imaging using MBI Gamma camera

Primary Outcome Measures

Name	Time	Method
To assess the feasibility, safety and acceptability to patients of the MBI Gamma camera.	1 year

Secondary Outcome Measures

Name	Time	Method
To explore the ability of the MBI Gamma camera to detect breast cancer.	1 year

Trial Locations

Locations (1)

Juravinski Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada