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

Study Overview
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Brief Summary
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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

Official Title
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The Hamilton Prospective Pilot Study To Investigate the Feasibility and Safety of A Dedicated High Resolution Nuclear Breast Imaging Camera

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: nuclear breast imaging using MBI Gamma camera


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nuclear breast imaging<br>nuclear breast imaging using MBI Gamma camera | Device: nuclear breast imaging using MBI Gamma camera<br>* nuclear breast imaging using MBI Gamma camera in addition to MRI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the feasibility, safety and acceptability to patients of the MBI Gamma camera. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To explore the ability of the MBI Gamma camera to detect breast cancer. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, molecular breast imaging, MRI, gamma camera