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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2017-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Women with lesion on MBI

Group Type EXPERIMENTAL

Molecular Breast Imaging

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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MBI

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes