Trial Outcomes & Findings for Evaluation of Half-Dose Molecular Breast Imaging With Wide Beam Reconstruction Processing (NCT NCT01653964)

Last Updated: 2017-09-18

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

83 participants

Primary outcome timeframe

At time of study (within 2 days after exam) and when enrollment has been reached (approximately 24 months)

Results posted on

2017-09-18

83 subjects were enrolled (consented) but 1 subject was found not to meet eligibility criteria, so did not participate in the study.

Participant milestones
Measure	Molecular Breast Imaging Molecular breast imaging performed after injection of 4 mCi Tc-99m sestamibi and again after 8 millicurie (mCi) Tc-99m sestamibi.
Overall Study STARTED	82
Overall Study COMPLETED	82
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Molecular Breast Imaging n=82 Participants Molecular Breast Imaging at 4 mCi dose and at 8 mCi dose, consecutively. Molecular breast imaging performed with injection of Tc-99m sestamibi and a dedicated gamma camera (Luma Gem, Gamma Medica)
Age, Continuous	57 years STANDARD_DEVIATION 11.3 • n=82 Participants
Sex: Female, Male Female	82 Participants n=82 Participants
Sex: Female, Male Male	0 Participants n=82 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=82 Participants
Race (NIH/OMB) Asian	0 Participants n=82 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=82 Participants
Race (NIH/OMB) Black or African American	0 Participants n=82 Participants
Race (NIH/OMB) White	82 Participants n=82 Participants
Race (NIH/OMB) More than one race	0 Participants n=82 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=82 Participants
Region of Enrollment United States	82 Participants n=82 Participants

Timeframe: At time of study (within 2 days after exam) and when enrollment has been reached (approximately 24 months)

Population: Of 82 patients recruited to the study (prior to breast biopsy), 34 had a histologically-proven diagnosis of breast cancer.

Outcome measures
Measure	Molecular Breast Imaging n=34 Participants Molecular breast imaging performed after injection of 4 mCi Tc-99m sestamibi and again after 8 mCi Tc-99m sestamibi.
Compare the Diagnostic Accuracy of 8 mCi Molecular Breast Imaging (MBI) With 4 mCi MBI. 8 mCi	30 cancers detected
Compare the Diagnostic Accuracy of 8 mCi Molecular Breast Imaging (MBI) With 4 mCi MBI. 4 mCi	29 cancers detected

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

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