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

Ontario Clinical Oncology Group (OCOG)

Status: Completed

Conditions: Breast Cancer

Treatments: Device: nuclear breast imaging using MBI Gamma camera

Study type: Interventional

Funder types: Other

Identifiers

NCT01062100

OCOG-2009-THORN

Details and patient eligibility

About

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

Enrollment: 42 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

nuclear breast imaging

Experimental group

Description:

nuclear breast imaging using MBI Gamma camera

Treatment:

Device: nuclear breast imaging using MBI Gamma camera