Trial Outcomes & Findings for Molecular Breast Imaging as a Screening Tool for Women With Dense Breasts (NCT NCT00620373)

NCT ID: NCT00620373

Last Updated: 2014-08-01

Results Overview

Diagnostic yield is the likelihood that a test or procedure will provide the information needed to establish a diagnosis. In this case, it is the proportion of women with positive results of a screening test and positive results with the reference standard (verified cancer status).

Recruitment status

COMPLETED

Study phase

Target enrollment

969 participants

Primary outcome timeframe

12 months after mammography and gamma imaging

Results posted on

2014-08-01

Participant Flow

Subjects were enrolled between September 2005 and February 2009 in Rochester, Minnesota.

969 subjects completed imaging and met eligibility criteria, but 33 were excluded because of lack of the reference standard (unverified cancer status).

Participant milestones

Participant milestones
Measure	Mammography and Molecular Breast Imaging Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ)(20-mCi) Technetium (99mTc) sestamibi injection.
Overall Study STARTED	969
Overall Study COMPLETED	936
Overall Study NOT COMPLETED	33

Reasons for withdrawal

Reasons for withdrawal
Measure	Mammography and Molecular Breast Imaging Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ)(20-mCi) Technetium (99mTc) sestamibi injection.
Overall Study Unverified cancer status	33

Baseline Characteristics

Molecular Breast Imaging as a Screening Tool for Women With Dense Breasts

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mammography and Molecular Breast Imaging n=969 Participants Participants underwent conventional mammography and molecular breast imaging after a 740-mBQ (20-mCi) Technetium (99mTc) sestamibi injection.
Age, Continuous	55.5 years n=5 Participants
Sex: Female, Male Female	969 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	969 participants n=5 Participants
Race or ethnicity White	860 participants n=5 Participants
Race or ethnicity Hispanic or Latina	1 participants n=5 Participants
Race or ethnicity Black or African American	1 participants n=5 Participants
Race or ethnicity Asian	6 participants n=5 Participants
Race or ethnicity American Indian or Alaskan Native	1 participants n=5 Participants
Race or ethnicity Unknown or data missing	100 participants n=5 Participants
Menopausal status Premenopausal	324 participants n=5 Participants
Menopausal status Perimenopausal	65 participants n=5 Participants
Menopausal status Postmenopause	529 participants n=5 Participants
Menopausal status Surgical menopause	51 participants n=5 Participants
Mammographic breast density Almost entirely fat	7 participants n=5 Participants
Mammographic breast density Scattered fibroglandular densities	129 participants n=5 Participants
Mammographic breast density Heterogeneously dense	702 participants n=5 Participants
Mammographic breast density Extremely dense	131 participants n=5 Participants
Risk factors Known mutation in BRCA1 or BRCA2 gene	5 participants n=5 Participants
Risk factors Prior chest, mediastinal, or auxiliary irradiation	1 participants n=5 Participants
Risk factors Prior biopsy showing hyperplasia, etc.	23 participants n=5 Participants
Risk factors Gail or Claus model lifetime risk ≥ 20%	165 participants n=5 Participants
Risk factors Gail model 5 year risk ≥ 2.5%	297 participants n=5 Participants
Risk factors Gail model 5 year risk ≥ 1.6%	238 participants n=5 Participants
Risk factors 1 first-deg relative with history of breast cancer	82 participants n=5 Participants
Risk factors 2 second-deg relatives history of breast cancer	85 participants n=5 Participants
Risk factors personal history of breast cancer	73 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months after mammography and gamma imaging

Population: The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and gamma imaging).

Outcome measures

Outcome measures
Measure	Mammography Only n=936 Participants For this reporting arm, the interpretation and analysis was done with mammography only.	Gamma Imaging n=936 Participants For this reporting arm, the interpretation and analysis was done with gamma imaging only.	Both Mammography and Gamma Imaging n=936 Participants For this reporting arm, the interpretation and analysis was done with both mammography and gamma images together.
Diagnostic Yield	3.2 cancers per 1000 women screened Interval 1.1 to 9.4	9.6 cancers per 1000 women screened Interval 5.1 to 18.2	10.7 cancers per 1000 women screened Interval 5.8 to 19.6

PRIMARY outcome

Timeframe: 12 months after mammography and gamma imaging

Population: The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and gamma imaging).

Outcome measures

Outcome measures
Measure	Mammography Only n=936 Participants For this reporting arm, the interpretation and analysis was done with mammography only.	Gamma Imaging For this reporting arm, the interpretation and analysis was done with gamma imaging only.	Both Mammography and Gamma Imaging For this reporting arm, the interpretation and analysis was done with both mammography and gamma images together.
Number of Participants With Cancer Diagnosis at 12 Months Ductal carcinoma in situ (DCIS)	4 participants	—	—
Number of Participants With Cancer Diagnosis at 12 Months Invasive cancer	7 participants	—	—

SECONDARY outcome

Timeframe: 12 months after mammography and gamma imaging

Population: The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and gamma imaging).

Sensitivity measures the proportion of actual positives which are correctly identified as such.

Outcome measures

Outcome measures
Measure	Mammography Only n=11 Participants For this reporting arm, the interpretation and analysis was done with mammography only.	Gamma Imaging n=11 Participants For this reporting arm, the interpretation and analysis was done with gamma imaging only.	Both Mammography and Gamma Imaging n=11 Participants For this reporting arm, the interpretation and analysis was done with both mammography and gamma images together.
Sensitivity All cancers	3 number of cancers diagnosed Interval 9.7 to 56.6	9 number of cancers diagnosed Interval 52.3 to 94.9	10 number of cancers diagnosed Interval 62.3 to 98.4
Sensitivity Invasive cancers	2 number of cancers diagnosed Interval 8.2 to 64.1	7 number of cancers diagnosed Interval 64.6 to 100.0	7 number of cancers diagnosed Interval 64.6 to 100.0
Sensitivity Ductal carcinoma in situ (DCIS)	1 number of cancers diagnosed Interval 4.6 to 69.9	2 number of cancers diagnosed Interval 15.0 to 85.0	3 number of cancers diagnosed Interval 30.0 to 95.4

SECONDARY outcome

Timeframe: 12 month after mammography and gamma imaging

Population: The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and gamma imaging). The number of participants negative for breast cancer was 936-11 = 925.

Specificity measures the proportion of negatives which are correctly identified as such.

Outcome measures

Outcome measures
Measure	Mammography Only n=925 Participants For this reporting arm, the interpretation and analysis was done with mammography only.	Gamma Imaging n=925 Participants For this reporting arm, the interpretation and analysis was done with gamma imaging only.	Both Mammography and Gamma Imaging n=925 Participants For this reporting arm, the interpretation and analysis was done with both mammography and gamma images together.
Specificity	840 number of true negatives Interval 88.8 to 92.5	861 number of true negatives Interval 91.3 to 94.5	788 number of true negatives Interval 82.8 to 87.3

SECONDARY outcome

Timeframe: 12 months after mammography and gamma imaging

Population: The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and gamma imaging).

Recall rate was defined as the percentage of participants recalled for follow-up studies initiated because of abnormal findings with mammography or gamma imaging.

Outcome measures

Outcome measures
Measure	Mammography Only n=936 Participants For this reporting arm, the interpretation and analysis was done with mammography only.	Gamma Imaging n=936 Participants For this reporting arm, the interpretation and analysis was done with gamma imaging only.	Both Mammography and Gamma Imaging n=936 Participants For this reporting arm, the interpretation and analysis was done with both mammography and gamma images together.
Recall Rate	9 percentage of participants Interval 7.7 to 11.4	8 percentage of participants Interval 6.1 to 9.5	15 percentage of participants Interval 13.1 to 17.7

Adverse Events

Mammography and 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. Deborah J. Rhodes

Mayo Clinic

Phone: 507-538-1703

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place