search
Back to results

The Assessment of Molecular Breast Imaging (MBI) in Distinguishing Benign From Malignant Breast Disease

Primary Purpose

Breast Abnormalities

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
molecular breast imaging (Discovery)
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Abnormalities focused on measuring molecular breast imaging, breast disease, breast biopsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years of age or older
  • Women who have indeterminate mammographic or sonographic findings who are recommended and for biopsy

Exclusion Criteria:

  • Known contraindication to mammographic imaging
  • women who are pregnant
  • women who are lactating
  • women who have significant existing breast trauma
  • women who have breast implants
  • Women under 18 years of age.
  • women who had previous benign breast surgery within 1 year
  • Males and children
  • Women who are unable to understand or execute written informed consent
  • Women who refuse to have a biopsy
  • Women with any known renal disease - if an MRI is deemed necessary, a serum creatine will be checked prior to injection of contrast. Using the National Kidney Foundation recommendations, a glomerular filtration rate (GFR) greater than 60 may safely receive intravenous gadolinium-based MRI contrast. Those individuals with a GFR >30 and <60 can receive the contrast but at a reduced dose (typically half). Those with a GFR <30 will not receive MRI contrast and will not undergo the exam. Breast MRI must be done with contrast if evaluating for cancer. Several factors can affect the GFR such as age, body size, creatinine, renal status and will be calculated from the blood drawn. GFR is the final determinant and a creatinine greater than 1.6 usually has a GFR that precludes a Breast MRI with contrast. The final determinant will be the GFR.

Sites / Locations

  • Hillman Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

molecular breast imaging

Arm Description

Outcomes

Primary Outcome Measures

Specificity of MBI. Specificity is Defined as the Number of True Negatives/ Total Number of Negative Pathology Results.
The number of indeterminate lesions with negative MBI uptake and negative/benign pathology results.Reported are number of indeterminate lesions with negative MBI uptake and negative/benign pathology results (true negatives).

Secondary Outcome Measures

Sensitivity of MBI. Sensitivity in This Case is Defined as the Number of True Positives/ Total Number of Positive Pathology Results.
Reported are the number of indeterminate lesions with marked, moderate, or mild uptake and positive pathology results (true positives).

Full Information

First Posted
September 11, 2012
Last Updated
July 31, 2016
Sponsor
University of Pittsburgh
Collaborators
GE Healthcare
search

1. Study Identification

Unique Protocol Identification Number
NCT01687790
Brief Title
The Assessment of Molecular Breast Imaging (MBI) in Distinguishing Benign From Malignant Breast Disease
Official Title
The Assessment of Molecular Breast Imaging (MBI) in Distinguishing Benign From Malignant Breast Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
GE Healthcare

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary hypothesis of this project is that using molecular breast imaging (MBI) in evaluating women with equivocal mammographic or sonographic findings will demonstrate high specificity in distinguishing benign from malignant breast disease and, as a result, decrease the number of biopsies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Abnormalities
Keywords
molecular breast imaging, breast disease, breast biopsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
molecular breast imaging
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
molecular breast imaging (Discovery)
Other Intervention Name(s)
Discovery NM750b
Primary Outcome Measure Information:
Title
Specificity of MBI. Specificity is Defined as the Number of True Negatives/ Total Number of Negative Pathology Results.
Description
The number of indeterminate lesions with negative MBI uptake and negative/benign pathology results.Reported are number of indeterminate lesions with negative MBI uptake and negative/benign pathology results (true negatives).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Sensitivity of MBI. Sensitivity in This Case is Defined as the Number of True Positives/ Total Number of Positive Pathology Results.
Description
Reported are the number of indeterminate lesions with marked, moderate, or mild uptake and positive pathology results (true positives).
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Women who have indeterminate mammographic or sonographic findings who are recommended and for biopsy Exclusion Criteria: Known contraindication to mammographic imaging women who are pregnant women who are lactating women who have significant existing breast trauma women who have breast implants Women under 18 years of age. women who had previous benign breast surgery within 1 year Males and children Women who are unable to understand or execute written informed consent Women who refuse to have a biopsy Women with any known renal disease - if an MRI is deemed necessary, a serum creatine will be checked prior to injection of contrast. Using the National Kidney Foundation recommendations, a glomerular filtration rate (GFR) greater than 60 may safely receive intravenous gadolinium-based MRI contrast. Those individuals with a GFR >30 and <60 can receive the contrast but at a reduced dose (typically half). Those with a GFR <30 will not receive MRI contrast and will not undergo the exam. Breast MRI must be done with contrast if evaluating for cancer. Several factors can affect the GFR such as age, body size, creatinine, renal status and will be calculated from the blood drawn. GFR is the final determinant and a creatinine greater than 1.6 usually has a GFR that precludes a Breast MRI with contrast. The final determinant will be the GFR.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christiane Hakim, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Assessment of Molecular Breast Imaging (MBI) in Distinguishing Benign From Malignant Breast Disease

We'll reach out to this number within 24 hrs