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

Breast Cancer Clinical Trial

— MBI/US  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01806558
• Other study ID #: 12-004900
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: June 1, 2017

Study information

• Verified date: June 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 1, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year

External Links

•   Mayo Clinic You Tube Channel