Trial Outcomes & Findings for Low Dose Molecular Breast Imaging as a Screening Tool for Women With Dense Breasts (NCT NCT01925170)
NCT ID: NCT01925170
Last Updated: 2014-08-19
Results Overview
The cancer detection rate per 1000 women screened is the estimate of the number of women with positive results from a screening test.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1638 participants
Primary outcome timeframe
Within 21 days of mammography
Results posted on
2014-08-19
Participant Flow
Women for the Part B low dose study were enrolled between 5/11/2009 and 3/8/2012.
Participant milestones
| Measure |
Mammography and Molecular Breast Imaging
Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (8-mCi) Technetium (99mTc) sestamibi injection.
Molecular Breast Imaging: Molecular breast imaging is a new nuclear medicine technique for imaging the breast. It uses small field of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.
Conventional Mammography: Mammography is the process of using low-energy X-rays (usually around 30 kVp) to examine the human breast and is used as a diagnostic and a screening tool.
Technetium (99mTc) sestamibi: Technetium (99mTc) sestamibi is a pharmaceutical agent used in nuclear medicine imaging. The drug is a coordination complex consisting of the radioisotope technetium-99m bound to six methoxyisobutylisonitrile (MIBI) ligands.
|
|---|---|
|
Overall Study
STARTED
|
1638
|
|
Overall Study
COMPLETED
|
1585
|
|
Overall Study
NOT COMPLETED
|
53
|
Reasons for withdrawal
| Measure |
Mammography and Molecular Breast Imaging
Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (8-mCi) Technetium (99mTc) sestamibi injection.
Molecular Breast Imaging: Molecular breast imaging is a new nuclear medicine technique for imaging the breast. It uses small field of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.
Conventional Mammography: Mammography is the process of using low-energy X-rays (usually around 30 kVp) to examine the human breast and is used as a diagnostic and a screening tool.
Technetium (99mTc) sestamibi: Technetium (99mTc) sestamibi is a pharmaceutical agent used in nuclear medicine imaging. The drug is a coordination complex consisting of the radioisotope technetium-99m bound to six methoxyisobutylisonitrile (MIBI) ligands.
|
|---|---|
|
Overall Study
Unverified cancer status
|
53
|
Baseline Characteristics
Low Dose Molecular Breast Imaging as a Screening Tool for Women With Dense Breasts
Baseline characteristics by cohort
| Measure |
Mammography and Molecular Breast Imaging
n=1638 Participants
Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (8-mCi) Technetium (99mTc) sestamibi injection.
Molecular Breast Imaging: Molecular breast imaging is a new nuclear medicine technique for imaging the breast. It uses small field of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.
Conventional Mammography: Mammography is the process of using low-energy X-rays (usually around 30 kVp) to examine the human breast and is used as a diagnostic and a screening tool.
Technetium (99mTc) sestamibi: Technetium (99mTc) sestamibi is a pharmaceutical agent used in nuclear medicine imaging. The drug is a coordination complex consisting of the radioisotope technetium-99m bound to six methoxyisobutylisonitrile (MIBI) ligands.
|
|---|---|
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Age, Continuous
|
58.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1638 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1605 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1638 participants
n=5 Participants
|
|
Menopausal Status
Premenopausal
|
355 participants
n=5 Participants
|
|
Menopausal Status
Peri-menopausal
|
186 participants
n=5 Participants
|
|
Menopausal Status
Postmenopausal
|
1021 participants
n=5 Participants
|
|
Menopausal Status
Surgical Menopause
|
76 participants
n=5 Participants
|
|
Mammographic Breast Density
Almost entirely fat
|
0 participants
n=5 Participants
|
|
Mammographic Breast Density
Scattered fibroglandular densities
|
149 participants
n=5 Participants
|
|
Mammographic Breast Density
Heterogeneously dense
|
1259 participants
n=5 Participants
|
|
Mammographic Breast Density
Extremely dense
|
230 participants
n=5 Participants
|
|
Risk Factors
Known mutation in BRCA1 or BRCA2 genes
|
3 participants
n=5 Participants
|
|
Risk Factors
Chest, mediastinal, or axillary irradiation
|
5 participants
n=5 Participants
|
|
Risk Factors
Personal history of breast cancer
|
166 participants
n=5 Participants
|
|
Risk Factors
Prior biopsy showing hyperplasia, etc.
|
21 participants
n=5 Participants
|
|
Risk Factors
Gail or Claus model lifetime risk ≥ 20%
|
78 participants
n=5 Participants
|
|
Risk Factors
Gail model 5 year risk ≥ 2.5%
|
203 participants
n=5 Participants
|
|
Risk Factors
Gail model 5 year risk ≥ 1.7%
|
360 participants
n=5 Participants
|
|
Risk Factors
1 first-deg relative with history of breast cancer
|
53 participants
n=5 Participants
|
|
Risk Factors
2 2nd-deg relatives with history of breast cancer
|
56 participants
n=5 Participants
|
|
Risk Factors
None of the above risk factors
|
693 participants
n=5 Participants
|
|
Mammogram Prior to Study Entry
< 425 days
|
1310 participants
n=5 Participants
|
|
Mammogram Prior to Study Entry
425-730 days
|
301 participants
n=5 Participants
|
|
Mammogram Prior to Study Entry
>730 days
|
20 participants
n=5 Participants
|
|
Mammogram Prior to Study Entry
None
|
7 participants
n=5 Participants
|
|
Molecular Breast Imaging Prior to Study Entry
< 425 days
|
0 participants
n=5 Participants
|
|
Molecular Breast Imaging Prior to Study Entry
415- 730 days
|
8 participants
n=5 Participants
|
|
Molecular Breast Imaging Prior to Study Entry
> 730 days
|
171 participants
n=5 Participants
|
|
Molecular Breast Imaging Prior to Study Entry
None
|
1459 participants
n=5 Participants
|
|
Breast Density of Participants with No Prior Mammogram
Scattered fibroglandular densities
|
2 participants
n=5 Participants
|
|
Breast Density of Participants with No Prior Mammogram
Heterogeneously dense breasts
|
5 participants
n=5 Participants
|
|
Breast Density of Participants with No Prior Mammogram
Participants with Prior Mammogram
|
1631 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 21 days of mammographyThe cancer detection rate per 1000 women screened is the estimate of the number of women with positive results from a screening test.
Outcome measures
| Measure |
Mammography Only
n=1585 Participants
For this reporting arm, the interpretation and analysis was done with mammography only.
|
Mammography With Adjunct MBI
n=1585 Participants
For this reporting arm, the interpretation and analysis was done with both mammography and MBI together.
|
Molecular Breast Imaging Alone
n=1585 Participants
For this reporting arm, the interpretation and analysis was done with gamma imaging only.
|
|---|---|---|---|
|
Cancer Detection Rate Per 1000 Women Screened, by Breast Density
All densities
|
3.2 cancers per 1000 women screened
Interval 1.3 to 7.4
|
12.0 cancers per 1000 women screened
Interval 7.7 to 18.6
|
10.7 cancers per 1000 women screened
Interval 6.7 to 17.1
|
|
Cancer Detection Rate Per 1000 Women Screened, by Breast Density
Scattered fibroglandular densities
|
0 cancers per 1000 women screened
Interval 0.0 to 26.2
|
21.0 cancers per 1000 women screened
Interval 7.2 to 59.9
|
21.0 cancers per 1000 women screened
Interval 7.2 to 59.9
|
|
Cancer Detection Rate Per 1000 Women Screened, by Breast Density
Heterogeneously dense
|
3.3 cancers per 1000 women screened
Interval 1.3 to 8.4
|
10.6 cancers per 1000 women screened
Interval 6.2 to 18.1
|
9.0 cancers per 1000 women screened
Interval 5.0 to 16.0
|
|
Cancer Detection Rate Per 1000 Women Screened, by Breast Density
Extremely dense
|
4.5 cancers per 1000 women screened
Interval 0.2 to 25.2
|
13.6 cancers per 1000 women screened
Interval 4.6 to 39.1
|
13.6 cancers per 1000 women screened
Interval 4.6 to 39.1
|
SECONDARY outcome
Timeframe: Within 21 days of mammographyPopulation: The analysis population only included participants with a verified negative cancer status at 12 months after the initial screening (mammography and MBI).
Specificity measures the percentage of negatives which are correctly identified as such.
Outcome measures
| Measure |
Mammography Only
n=1564 Participants
For this reporting arm, the interpretation and analysis was done with mammography only.
|
Mammography With Adjunct MBI
n=1564 Participants
For this reporting arm, the interpretation and analysis was done with both mammography and MBI together.
|
Molecular Breast Imaging Alone
n=1564 Participants
For this reporting arm, the interpretation and analysis was done with gamma imaging only.
|
|---|---|---|---|
|
Specificity
|
89.1 percentage of true negatives
Interval 87.5 to 90.6
|
83.4 percentage of true negatives
Interval 81.4 to 85.1
|
93.5 percentage of true negatives
Interval 92.1 to 94.6
|
SECONDARY outcome
Timeframe: Within 21 days of mammographyPopulation: The analysis population only included participants with a verified cancer status at 12 months after the initial screening. 21 participants out of the total study population of 1585 were diagnosed with cancer.
Sensitivity measures the percentage of actual positives which are correctly identified as such.
Outcome measures
| Measure |
Mammography Only
n=21 Participants
For this reporting arm, the interpretation and analysis was done with mammography only.
|
Mammography With Adjunct MBI
n=21 Participants
For this reporting arm, the interpretation and analysis was done with both mammography and MBI together.
|
Molecular Breast Imaging Alone
n=21 Participants
For this reporting arm, the interpretation and analysis was done with gamma imaging only.
|
|---|---|---|---|
|
Sensitivity for All Cancers Diagnosed
|
23.8 percentage of actual positives
Interval 10.6 to 45.1
|
90.5 percentage of actual positives
Interval 71.1 to 97.3
|
81.0 percentage of actual positives
Interval 60.0 to 91.3
|
SECONDARY outcome
Timeframe: 12 months after mammography and MBIPopulation: The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and MBI).
Recall rate was defined as the percentage of participants recalled for follow-up studies initiated because of abnormal findings with mammography or MBI.
Outcome measures
| Measure |
Mammography Only
n=1585 Participants
For this reporting arm, the interpretation and analysis was done with mammography only.
|
Mammography With Adjunct MBI
n=1585 Participants
For this reporting arm, the interpretation and analysis was done with both mammography and MBI together.
|
Molecular Breast Imaging Alone
n=1585 Participants
For this reporting arm, the interpretation and analysis was done with gamma imaging only.
|
|---|---|---|---|
|
Recall Rate
|
11.0 percentage of participants
Interval 9.6 to 12.7
|
17.6 percentage of participants
Interval 15.8 to 19.6
|
7.5 percentage of participants
Interval 6.3 to 8.9
|
SECONDARY outcome
Timeframe: 12 months after mammography and MBIBiopsy rate = number of participants who had a biopsy/number of number of participants analyzed.
Outcome measures
| Measure |
Mammography Only
n=1585 Participants
For this reporting arm, the interpretation and analysis was done with mammography only.
|
Mammography With Adjunct MBI
n=1585 Participants
For this reporting arm, the interpretation and analysis was done with both mammography and MBI together.
|
Molecular Breast Imaging Alone
n=1585 Participants
For this reporting arm, the interpretation and analysis was done with gamma imaging only.
|
|---|---|---|---|
|
Biopsy Rate
|
1.3 percentage of participants
Interval 0.8 to 1.9
|
4.2 percentage of participants
Interval 3.3 to 5.3
|
3.2 percentage of participants
Interval 2.5 to 4.2
|
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place