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OpenTrials
Completed

NCT Number: NCT00943644

Pre-biopsy With Dynamic Acquisitions

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Molecular Breast Imaging (MBI)

Device

To determine the sensitivity of MBI

CZT semiconductor detectors

Device

Dual headed CZT semiconductor detectors

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Susan G. Komen Breast Cancer Foundation

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Jul 22, 2009
Registry last updated
Dec 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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