Pre-biopsy With Dynamic Acquisitions

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00943644
• Other study ID #: 17-05
• Secondary ID: BCTR0504394
• Status: Completed
• Phase: N/A
• First received: November 10, 2008
• Last updated: December 14, 2011
• Start date: August 2005
• Est. completion date: September 2010

Study information

• Verified date: December 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Susan G. Komen Breast Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2 years	No

External Links

•   Mayo Clinic Clinical Trials