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

NCT ID: NCT01062100

Last Updated: 2013-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2013-02-28

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

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

nuclear breast imaging

nuclear breast imaging using MBI Gamma camera

Group Type: EXPERIMENTAL

nuclear breast imaging using MBI Gamma camera

Intervention Type: DEVICE

nuclear breast imaging using MBI Gamma camera in addition to MRI

Interventions

nuclear breast imaging using MBI Gamma camera

nuclear breast imaging using MBI Gamma camera in addition to MRI

Intervention Type: DEVICE

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
• Prior breast biopsy or surgery within 3 months

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ontario Clinical Oncology Group (OCOG)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregory Pond

Role: PRINCIPAL_INVESTIGATOR

Ontario Clinical Oncology Group - McMaster University

Karen Gulenchyn

Role: PRINCIPAL_INVESTIGATOR

Hamilton Health Sciences Corporation

Locations

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

OCOG-2009-THORN

Identifier Type: -

Identifier Source: org_study_id