Trial Outcomes & Findings for The Assessment of Molecular Breast Imaging (MBI) in Distinguishing Benign From Malignant Breast Disease (NCT NCT01687790)

NCT ID: NCT01687790

Last Updated: 2016-09-20

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2016-09-20

Participant Flow

single group

Participant milestones

Measure	Molecular Breast Imaging molecular breast imaging (Discovery)
Overall Study STARTED	60
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Molecular Breast Imaging n=60 Participants molecular breast imaging (Discovery)
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	47 Participants n=93 Participants
Age, Categorical >=65 years	13 Participants n=93 Participants
Age, Continuous	56 years n=93 Participants
Sex: Female, Male Female	60 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	24 Participants n=93 Participants
Race (NIH/OMB) White	34 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	60 participants n=93 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Analysis population included the number of indeterminate lesions that had negative/benign 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).

Outcome measures

Measure	Molecular Breast Imaging n=42 Participants Participants received molecular breast imaging before biopsy
Specificity of MBI. Specificity is Defined as the Number of True Negatives/ Total Number of Negative Pathology Results.	27 lesions

SECONDARY outcome

Timeframe: 1 year

Population: Analysis population included the number of indeterminate lesions that had positive pathology results.

Reported are the number of indeterminate lesions with marked, moderate, or mild uptake and positive pathology results (true positives).

Outcome measures

Measure	Molecular Breast Imaging n=20 Participants Participants received molecular breast imaging before biopsy
Sensitivity of MBI. Sensitivity in This Case is Defined as the Number of True Positives/ Total Number of Positive Pathology Results.	19 lesions

Adverse Events

Molecular Breast Imaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Christiane Hakim

University of Pittsburgh

Phone: 412-641-1965

Email: chakim@magee.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place