We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01806558
First Posted: March 7, 2013
Last Update Posted: August 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael O'Connor, Mayo Clinic
  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
Masking: None (Open Label)
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 Michael O'Connor, 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 ]
    Presence / absence of correlation between lesion seen on ultrasound and lesion seen on MBI.


Enrollment: 12
Actual Study Start Date: September 2012
Study Completion Date: June 1, 2017
Primary Completion Date: May 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Women with lesion on MBI
Women with lesion on MBI
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: March 1, 2013
First Posted: March 7, 2013
Last Update Posted: August 29, 2017
Last Verified: August 2017

Keywords provided by Michael O'Connor, Mayo Clinic:
Breast cancer
molecular breast imaging
breast
breast lesion