Skip to main content
OpenTrials
Completed

NCT Number: NCT01806558

Pilot Study: Combined Molecular Breast Imaging/Ultrasound System for Diagnostic Evaluation of MBI-detected Lesions

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The pilot study will comprise 12 women age 40 and older who have at least one of the following inclusion criteria:
  • 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.
  • Have a finding of a mass lesion on ultrasound (BIRADS 0, 4 or 5) that is > 0.5 cm and < 2 cm in size.
  • Have a positive finding on MBI that is < 2 cm in size and requires additional diagnostic workup with focused ultrasound.

Exclusion criteria

  • Are unable to understand and sign the consent form
  • Are pregnant or lactating
  • Are physically unable to sit upright and still for 40 minutes
  • Have undergone bilateral mastectomy
  • Are not scheduled to undergo conventional ultrasound

Treatment and study plan

Molecular Breast Imaging

Procedure

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.

Other names: MBI

Primary outcomes

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

    Time frame: 1 year

    Presence / absence of correlation between lesion seen on ultrasound and lesion seen on MBI.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Acronym: MBI/US

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Mar 7, 2013
Registry last updated
Jul 3, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.