This trial is active, not recruiting.

Condition breast cancer
Treatment molecular breast imaging
Sponsor Mayo Clinic
Start date September 2012
End date June 2017
Trial size 12 participants
Trial identifier NCT01806558, 12-004900


A combined molecular breast imaging / ultrasound system will enable coregistration of a functional abnormality seen on Molecular Breast Imaging (MBI) with the corresponding anatomical abnormality seen on ultrasound.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Women with lesion on MBI
molecular breast imaging MBI
Molecular breast Imaging is a new nuclear medicine technique for imaging the breast. It uses small filed of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.

Primary Outcomes

To evaluate the potential benefits of co-registered MBI and ultrasonic information relative to independent acquisition of each modality.
time frame: 1 year

Eligibility Criteria

Female participants at least 40 years old.

Inclusion Criteria: - The pilot study will comprise 12 women age 40 and older who have at least one of the following inclusion criteria: 1. Have a finding of a mass lesion on mammography or breast MRI (BIRADS 0, 4 or 5) that is >0.5 cm and < 2 cm in size and has had or will have additional workup with focused ultrasound. 2. Have a finding of a mass lesion on ultrasound (BIRADS 0, 4 or 5) that is > 0.5 cm and < 2 cm in size. 3. Have a positive finding on MBI that is < 2 cm in size and requires additional diagnostic workup with focused ultrasound. Exclusion Criteria: 1. Are unable to understand and sign the consent form 2. Are pregnant or lactating 3. Are physically unable to sit upright and still for 40 minutes 4. Have undergone bilateral mastectomy 5. Are not scheduled to undergo conventional ultrasound

Additional Information

Official title Pilot Study: Combined Molecular Breast Imaging/Ultrasound System for Diagnostic Evaluation of MBI-detected Lesions
Principal investigator Michael K O'Connor, PhD, R-D
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.