NCT01062100CompletedNot Applicable
The Hamilton Prospective Pilot Study To Investigate the Feasibility and Safety of A Dedicated High Resolution Nuclear Breast Imaging Camera
Ontario Clinical Oncology Group (OCOG)1 site in 1 country42 target enrollmentStarted: February 1, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- To assess the feasibility, safety and acceptability to patients of the MBI Gamma camera.
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
To assess the feasibility, safety and acceptability to patients of the MBI Gamma camera.
Time Frame: 1 year
Secondary Outcomes
- To explore the ability of the MBI Gamma camera to detect breast cancer.(1 year)
Investigators
Study Sites (1)
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