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Completed

NCT Number: NCT01062100

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nuclear breast imaging using MBI Gamma camera

Device

nuclear breast imaging using MBI Gamma camera in addition to MRI

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

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

    Time frame: 1 year

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Ontario Clinical Oncology Group (OCOG)

Other

Registry information

Official study title

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

Acronym: THORN

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Feb 4, 2010
Registry last updated
Feb 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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