Trial Outcomes & Findings for Comparison of MRI and Molecular Breast Imaging in Breast Diagnostic Evaluation (NCT NCT00591864)

NCT ID: NCT00591864

Last Updated: 2014-07-09

Results Overview

Sensitivity is the number of women with breast cancer detected per number of women with breast cancer diagnosed by surgery or biopsy.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 89 participants
• Primary outcome timeframe: within 1 week of surgery or biopsy
• Results posted on: 2014-07-09

Participant Flow

Participant milestones

Measure	Participants Imaged With MBI and MRI The group includes patients who underwent both MBI and breast MRI within the same 3 week period.
Overall Study STARTED	89
Overall Study COMPLETED	84
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Participants Imaged With MBI and MRI The group includes patients who underwent both MBI and breast MRI within the same 3 week period.
Overall Study Incomplete Imaging	5

Baseline Characteristics

Comparison of MRI and Molecular Breast Imaging in Breast Diagnostic Evaluation

Baseline characteristics by cohort

Measure	Study Participants n=89 Participants There are no arms or subgroups in this study.
Age, Continuous	53 Years n=5 Participants
Sex: Female, Male Female	89 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: within 1 week of surgery or biopsy

Population: In the 84 patients who completed the study 28 were diagnosed with breast cancer.

Sensitivity is the number of women with breast cancer detected per number of women with breast cancer diagnosed by surgery or biopsy.

Outcome measures

Measure	Study Participants n=28 Participants There are no arms or subgroups in this study.
Sensitivity on the Per Patient Level Sensitivity by MBI	25 participants
Sensitivity on the Per Patient Level Sensitivity by MRI	27 participants

SECONDARY outcome

Timeframe: within 1 week of surgery or biopsy

Number of tumors detected per number of tumors diagnosed on surgery or biopsy.

Outcome measures

Measure	Study Participants n=37 tumors There are no arms or subgroups in this study.
Sensitivity on the Per Tumor Level sensitivity by MBI	32 tumors
Sensitivity on the Per Tumor Level sensitivity by MRI	36 tumors

SECONDARY outcome

Timeframe: at least one year following imaging

The number of women with negative imaging test per number of women without cancer.

Outcome measures

Measure	Study Participants n=56 Participants There are no arms or subgroups in this study.
Specificity specificity by MRI	37 participants
Specificity specificity by MBI	38 participants

Adverse Events

Study Participants

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

Amy Lynn Conners MD

Mayo Clinic

Phone: (507) 284-2511

Email: MBI@mayo.edu

Results disclosure agreements

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