Pre-biopsy With Dynamic Acquisitions

December 14, 2011 updated by: Mayo Clinic

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

185

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Susan G. Komen Breast Cancer Foundation

Investigators

  • Principal Investigator: Deborah J. Rhodes, M.D., Mayo Clinic
  • Principal Investigator: Michael K. O'Connor, Ph.D., Mayo Clinic
  • Principal Investigator: Douglas A. Collins, M.D., Mayo Clinic
  • Principal Investigator: Carrie B. Hruska, Ph.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

November 10, 2008

First Submitted That Met QC Criteria

July 21, 2009

First Posted (Estimate)

July 22, 2009

Study Record Updates

Last Update Posted (Estimate)

December 16, 2011

Last Update Submitted That Met QC Criteria

December 14, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-05
  • BCTR0504394

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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