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Clinical Trials/NCT01062100
NCT01062100
Completed
Not 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 enrollmentFebruary 2010
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ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Ontario Clinical Oncology Group (OCOG)
Enrollment
42
Locations
1
Primary Endpoint
To assess the feasibility, safety and acceptability to patients of the MBI Gamma camera.
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

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

Registry
clinicaltrials.gov
Start Date
February 2010
End Date
February 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Ontario Clinical Oncology Group (OCOG)
Responsible Party
Sponsor

Eligibility 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

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)

Study Sites (1)

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