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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
nuclear breast imaging using MBI Gamma camera
Sponsored by
Ontario Clinical Oncology Group (OCOG)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring breast cancer, molecular breast imaging, MRI, gamma camera

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Juravinski Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

nuclear breast imaging

Arm Description

nuclear breast imaging using MBI Gamma camera

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 2, 2010
Last Updated
February 15, 2013
Sponsor
Ontario Clinical Oncology Group (OCOG)
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1. Study Identification

Unique Protocol Identification Number
NCT01062100
Brief Title
Study To Investigate the Feasibility and Safety of A Dedicated High Resolution Nuclear Breast Imaging Camera
Acronym
THORN
Official Title
The Hamilton Prospective Pilot Study To Investigate the Feasibility and Safety of A Dedicated High Resolution Nuclear Breast Imaging Camera
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ontario Clinical Oncology Group (OCOG)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, molecular breast imaging, MRI, gamma camera

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nuclear breast imaging
Arm Type
Experimental
Arm Description
nuclear breast imaging using MBI Gamma camera
Intervention Type
Device
Intervention Name(s)
nuclear breast imaging using MBI Gamma camera
Intervention Description
nuclear breast imaging using MBI Gamma camera in addition to MRI
Primary Outcome Measure Information:
Title
To assess the feasibility, safety and acceptability to patients of the MBI Gamma camera.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To explore the ability of the MBI Gamma camera to detect breast cancer.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Pond
Organizational Affiliation
Ontario Clinical Oncology Group - McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karen Gulenchyn
Organizational Affiliation
Hamilton Health Sciences Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

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

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