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

Primary Purpose

Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Molecular Breast Imaging

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast cancer, molecular breast imaging, breast, breast lesion

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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:

Are unable to understand and sign the consent form
Are pregnant or lactating
Are physically unable to sit upright and still for 40 minutes
Have undergone bilateral mastectomy
Are not scheduled to undergo conventional ultrasound

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Women with lesion on MBI

Arm Description

Women with lesion on MBI

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01806558

First Posted

March 1, 2013

Last Updated

June 29, 2023

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT01806558

Brief Title

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

Acronym

MBI/US

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

September 2012 (Actual)

Primary Completion Date

May 31, 2017 (Actual)

Study Completion Date

June 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mayo Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Breast cancer, molecular breast imaging, breast, breast lesion

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Women with lesion on MBI

Arm Type

Experimental

Arm Description

Women with lesion on MBI

Intervention Type

Procedure

Intervention Name(s)

Molecular Breast Imaging

Other Intervention Name(s)

MBI

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

1 year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The pilot study will comprise 12 women age 40 and older who have at least one of the following inclusion criteria: 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. Have a finding of a mass lesion on ultrasound (BIRADS 0, 4 or 5) that is > 0.5 cm and < 2 cm in size. Have a positive finding on MBI that is < 2 cm in size and requires additional diagnostic workup with focused ultrasound. Exclusion Criteria: Are unable to understand and sign the consent form Are pregnant or lactating Are physically unable to sit upright and still for 40 minutes Have undergone bilateral mastectomy Are not scheduled to undergo conventional ultrasound

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael K O'Connor, PhD, R-D

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21045179

Citation

Rhodes DJ, Hruska CB, Phillips SW, Whaley DH, O'Connor MK. Dedicated dual-head gamma imaging for breast cancer screening in women with mammographically dense breasts. Radiology. 2011 Jan;258(1):106-18. doi: 10.1148/radiol.10100625. Epub 2010 Nov 2.

Results Reference

result

Links:

URL

http://www.youtube.com/watch?v=DOQBLe8MdH0

Description

Mayo Clinic You Tube Channel

Learn more about this trial

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

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