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

Breast Cancer Clinical Trial

— THORN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01062100
• Other study ID #: OCOG-2009-THORN
• Status: Completed
• Phase: N/A
• First received: February 2, 2010
• Last updated: February 15, 2013
• Start date: February 2010
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: Ontario Clinical Oncology Group (OCOG)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• nuclear breast imaging using MBI Gamma camera
nuclear breast imaging using MBI Gamma camera in addition to MRI

Locations

Country	Name	City	State
Canada	Juravinski Cancer Centre	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ontario Clinical Oncology Group (OCOG)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the feasibility, safety and acceptability to patients of the MBI Gamma camera.		1 year	Yes
Secondary	To explore the ability of the MBI Gamma camera to detect breast cancer.		1 year	No