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


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Gregory Pond

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ontario Clinical Oncology Group - McMaster University

Authority:

Canada: Health Canada

Study ID:

OCOG-2009-THORN

NCT ID:

NCT01062100

Start Date:

February 2010

Completion Date:

February 2013

Related Keywords:

  • Breast Cancer
  • breast cancer
  • molecular breast imaging
  • MRI
  • gamma camera
  • Breast Neoplasms

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