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


N/A
40 Years
N/A
Open (Enrolling by invite only)
Female
Breast Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Michael K O'Connor, PhD, R-D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

12-004900

NCT ID:

NCT01806558

Start Date:

September 2012

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • molecular breast imaging
  • breast
  • breast lesion
  • Breast Neoplasms

Name

Location

Mayo Clinic Rochester, Minnesota  55905