Pre-biopsy With Dynamic Acquisitions

This study has been completed.
Sponsor:
Collaborator:
Susan G. Komen Breast Cancer Foundation
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00943644
First received: November 10, 2008
Last updated: December 14, 2011
Last verified: December 2011
  Purpose

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


Condition Intervention
Breast Cancer
Device: Molecular Breast Imaging (MBI)
Device: CZT semiconductor detectors

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 185
Study Start Date: August 2005
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Molecular Breast Imaging (MBI)
    To determine the sensitivity of MBI
    Device: CZT semiconductor detectors
    Dual headed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Michael O'Connor, Ph.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00943644     History of Changes
Other Study ID Numbers: 17-05, BCTR0504394
Study First Received: November 10, 2008
Last Updated: December 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
MBI
Breast
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014