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Pre-biopsy With Dynamic Acquisitions

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ClinicalTrials.gov Identifier: NCT00943644
Recruitment Status : Completed
First Posted : July 22, 2009
Last Update Posted : December 16, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
This study is being done to test the ability of an investigational mammography camera to find small tumors in patients' breasts.

Condition or disease Intervention/treatment
Breast Cancer Device: Molecular Breast Imaging (MBI) Device: CZT semiconductor detectors

Detailed Description:
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.

Study Design

Study Type : Observational
Actual Enrollment : 185 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Determination of Sensitivity of a Dual-Headed Small Field of View Gamma Camera for the Detection of Small Breast Lesions
Study Start Date : August 2005
Primary Completion Date : September 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Device: Molecular Breast Imaging (MBI)
    To determine the sensitivity of MBI
    Device: CZT semiconductor detectors
    Dual headed CZT semiconductor detectors

Outcome Measures

Primary Outcome Measures :
  1. 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. [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients that are scheduled to have a biopsy at the Mayo Clinic in Rochester, MN and have a lesion less the 2 cm
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00943644


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Susan G. Komen Breast Cancer Foundation
Investigators
Principal Investigator: Michael K. O'Connor, Ph.D. Mayo Clinic
Principal Investigator: Deborah J. Rhodes, M.D. Mayo Clinic
Principal Investigator: Douglas A. Collins, M.D. Mayo Clinic
Principal Investigator: Carrie B. Hruska, Ph.D. Mayo Clinic
More Information

Additional Information:
Responsible Party: Michael O'Connor, Ph.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00943644     History of Changes
Other Study ID Numbers: 17-05
BCTR0504394
First Posted: July 22, 2009    Key Record Dates
Last Update Posted: December 16, 2011
Last Verified: December 2011

Keywords provided by Mayo Clinic:
MBI
Breast
Breast Cancer