Use of Low-dose Molecular Breast Imaging for the Detection of Small Breast Lesions

Completed

Conditions studied: Suspicious Breast Lesion for Which Biopsy is Scheduled

In brief

The purpose of this study is to show that improvements in the molecular breast imaging (MBI) technology will allow reduction of the administered dose of Tc-99m sestamibi while maintaining a sensitivity of 90% for tumor detection.

Key facts

Study ID

NCT01285440

Run by

Mayo Clinic

People needed

150

Starts

2010-03-01

Expected to finish

2016-12-01

Last updated by the study team

2017-11-09

Who can join

Age: 18 and older, up to 95. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients referred for a mammogram, ultrasound or breast MRI study at Mayo Clinic Rochester will be considered for the study if they meet the following criteria:
• Have a lesion on mammogram, ultrasound or breast MRI that measured < 2 cm and is considered suspicious or highly suggestive of malignancy according to the Breast Imaging Reporting and Data System Atlas criteria (BI-RADS 4 or 5). (Note: while 2 cm is larger than the desired lesion size that we wish to study, this limit was recommended by our radiology colleagues as estimates of lesion size from mammography, ultrasound and MRI are not exact)
• Are scheduled for biopsy (needle and/or surgical biopsy) of the suspicious lesion
• Are > 18 years of age
• Had a negative pregnancy test or must be postmenopausal or surgically sterilized

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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