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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Molecular Breast Imaging

• Registration Number: NCT01806558
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-03-01
• Study First Submitted QC: 2013-03-05
• Study First Posted: 2013-03-07
• Primary Completion: 2017-05-31
• Study Completion: 2017-06-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-29
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Women with lesion on MBI	Molecular Breast Imaging	Women with lesion on MBI

Primary Outcome Measures

Name	Time	Method
To evaluate the potential benefits of co-registered MBI and ultrasonic information relative to independent acquisition of each modality.	1 year	Presence / absence of correlation between lesion seen on ultrasound and lesion seen on MBI.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States