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

NCT01062100 | Completed

• 1 other identifier: OCOG-2009-THORN
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Keywords

breast cancer; molecular breast imaging; MRI; gamma camera

Outcome Measures

Primary Outcomes (1)

• To assess the feasibility, safety and acceptability to patients of the MBI Gamma camera.

  1 year

Secondary Outcomes (1)

• To explore the ability of the MBI Gamma camera to detect breast cancer.

  1 year

Study Arms (1)

nuclear breast imaging

EXPERIMENTAL

nuclear breast imaging using MBI Gamma camera

Device: nuclear breast imaging using MBI Gamma camera

Interventions

nuclear breast imaging using MBI Gamma camera DEVICE

nuclear breast imaging using MBI Gamma camera in addition to MRI

nuclear breast imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ontario Clinical Oncology Group (OCOG): lead

Study Sites (1)

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gregory Pond

  Ontario Clinical Oncology Group - McMaster University

  PRINCIPAL INVESTIGATOR

• Karen Gulenchyn

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 4, 2010
• Study Start: February 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: February 1, 2013
• Last Updated: February 18, 2013

Record last verified: 2013-02

Locations

CA (1)