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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Michael O'Connor, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01806558
First received: March 1, 2013
Last updated: September 6, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Breast Cancer
Procedure: Molecular Breast Imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Diagnostic
Official Title: Pilot Study: Combined Molecular Breast Imaging/Ultrasound System for Diagnostic Evaluation of MBI-detected Lesions

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • To evaluate the potential benefits of co-registered MBI and ultrasonic information relative to independent acquisition of each modality. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Presence / absence of correlation between lesion seen on ultrasound and lesion seen on MBI.


Estimated Enrollment: 12
Study Start Date: September 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Molecular Breast Imaging
    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 Name: MBI
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01806558

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Michael K O'Connor, PhD, R-D Mayo Clinic
  More Information

Additional Information:
Publications:
Responsible Party: Michael O'Connor, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01806558     History of Changes
Other Study ID Numbers: 12-004900
Study First Received: March 1, 2013
Last Updated: September 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Breast cancer
molecular breast imaging
breast
breast lesion

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 19, 2014