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Determination of Sensitivity of a Dual-Headed Small Field of View Gamma Camera for the Detection of Small Breast Lesions


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

Thank you

Trial Information

Determination of Sensitivity of a Dual-Headed Small Field of View Gamma Camera for the Detection of Small Breast Lesions


If you agree to take part in this study, you will be asked to remove your clothes from the
waist up and put on a gown. A female technologist will give you an injection of Tc-99m
sestamibi in a vein in your arm. This is a drug routinely used for breast imaging. About 10
minutes after your injection, you will be asked to sit in a chair for about 40 minutes. The
technologist will position your breast between two small cameras. The cameras will apply a
very light compression to your breast to make sure there is no movement during the picture.
We will take two pictures of each breast. Each picture takes 10 minutes. You will also be
asked to fill out a short questionnaire. If you are found to have additional breast lesions,
your doctor and radiologist will be notified so that additional imaging or biopsies can be
performed.


Inclusion Criteria:



- Have a lesion on Mammogram, Ultrasound or MRI that measured < 2 cm and considered
suspicious or suggestive of malignancy

- Scheduled for biopsy of lesion

- > 18 years of age

- Negative pregnancy test, postmenopausal, or surgically sterilized

Exclusion Criteria:

- Prior needle biopsy

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

To determine the sensitivity of the dual-head system relative to single-head for detection of sub 10 mm breast lesions, and to determine the number of images that need to be acquired.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Michael K. O'Connor, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

17-05

NCT ID:

NCT00943644

Start Date:

August 2005

Completion Date:

September 2010

Related Keywords:

  • Breast Cancer
  • MBI
  • Breast
  • Breast Cancer
  • Breast Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905