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| Name | Class |
|---|---|
| Susan G. Komen Breast Cancer Foundation | OTHER |
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A new test for breast cancer screening, molecular breast imaging (MBI) may be more sensitive than mammography for detecting breast cancer in women with dense breasts. The purpose of this study is to see if MBI using a low dose of gamma radiation can find cancers not seen on mammography.
Hypotheses: 1. Low-Dose MBI has a significantly higher sensitivity and specificity and equal or higher positive predictive value than SM in women age 40 and older with mammographically dense breasts. 2. Low-dose MBI has comparable sensitivity and specificity to that previously achieved with MBI using a higher dose of radiation. 3. MBI produces a low false positive rate (specificity >90%) that permits its use as a screening tool in this patient population.
A previous study demonstrated that the addition of MBI using 20 mCi Tc-99m sestamibi to screening mammography (SM) increased diagnostic yield for breast cancer in dense breasts (supplemental yield of 7.5/1000 screened). After implementing radiation dose reduction techniques, the performance of incident SM and prevalent screen MBI in women with dense breasts will be compared.
Methods:
Women presenting for SM with heterogeneously or extremely dense breasts on past prior SM were enrolled and underwent digital SM and MBI. Study information was sent to all eligible patients in advance of their scheduled SM explaining the study and offering them participation. Eligible patients who requested to participate were offered an MBI on the same day as their SM or within 21 days of the SM. Participants may have participated in this screening study up to two times provided at least 24 months had elapsed since the initial MBI scan. This time period was selected as the average time for a tumor to double in size is approximately 20 months. Hence a 24 month time interval between MBI studies was to enable detection of interval cancers or cancers that were too small to be detected in the initial MBI scan.
MBI was performed with 8 mCi Tc-99m sestamibi and dual-head cadmium zinc telluride detectors. SMs were read independently; MBIs were read in comparison with SM. MBIs were assigned an assessment score of 1-5 which parallels BI-RADS; scores of 3-5 on MBI were considered positive.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mammography and Molecular Breast Imaging | Experimental | Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (8-mCi) Technetium (99mTc) sestamibi injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Molecular Breast Imaging | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer Detection Rate Per 1000 Women Screened, by Breast Density | The cancer detection rate per 1000 women screened is the estimate of the number of women with positive results from a screening test. | Within 21 days of mammography |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity | Specificity measures the percentage of negatives which are correctly identified as such. | Within 21 days of mammography |
| Sensitivity for All Cancers Diagnosed | Sensitivity measures the percentage of actual positives which are correctly identified as such. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah J Rhodes, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21045179 | Background | Rhodes DJ, Hruska CB, Phillips SW, Whaley DH, O'Connor MK. Dedicated dual-head gamma imaging for breast cancer screening in women with mammographically dense breasts. Radiology. 2011 Jan;258(1):106-18. doi: 10.1148/radiol.10100625. Epub 2010 Nov 2. |
| Label | URL |
|---|---|
| 1337-05 Part A, High-Dose Molecular Breast Imaging | View source |
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Women for the Part B low dose study were enrolled between 5/11/2009 and 3/8/2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | At the beginning of the study, the protocol inclusion criteria allowed women aged 25 years and older to participate. Between the dates of 5/11/09 and 4/20/10 there were 13 women under age 40 enrolled. On 4/20/2010 a protocol revision was approved by the Institutional Review Board to allow women aged 40 and older. In the final analyzable dataset of 1585 women who completed the study and had reference standard, 6 women were under age 40. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cancer Detection Rate Per 1000 Women Screened, by Breast Density | The cancer detection rate per 1000 women screened is the estimate of the number of women with positive results from a screening test. | Posted | Number | 95% Confidence Interval | cancers per 1000 women screened | Within 21 days of mammography |
|
Participants were followed for adverse events while they were on the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mammography and Molecular Breast Imaging | Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (8-mCi) Technetium (99mTc) sestamibi injection. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Deborah Rhodes | Mayo Clinic | 507-284-7971 | rhodes.deborah@mayo.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D017256 | Technetium Tc 99m Sestamibi |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D015609 | Organotechnetium Compounds |
| D009942 | Organometallic Compounds |
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|
| Conventional Mammography | Device | 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 | Drug | 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. |
|
|
| Within 21 days of mammography |
| Recall Rate | Recall rate was defined as the percentage of participants recalled for follow-up studies initiated because of abnormal findings with mammography or MBI. | 12 months after mammography and MBI |
| Biopsy Rate | Biopsy rate = number of participants who had a biopsy/number of number of participants analyzed. | 12 months after mammography and MBI |
| Mean |
| Full Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Menopausal Status | Number | participants |
|
| Mammographic Breast Density | Eligibility was determined by density assessed on a previous mammogram prior to study entry; mammographic density reported refers to density assessed from the study mammogram. | Number | participants |
|
| Risk Factors | Although participants may have qualified for multiple risk factor categories, they were assigned to only one risk factor category in this table. These risk factors are listed in order of priority. The last two risk factors with respect to first and second-degree relatives with a history of breast cancer refer to subjects who qualified on the basis of family history but did not meet the Gail or Claus model risk threshold levels. The Gail risk model focuses on nongenetic risk factors, with limited information on family history. The Claus risk model focuses on genetic risk factors. | Number | participants |
|
| Mammogram Prior to Study Entry | A total of 7 women under the age of 50 with no prior mammogram were enrolled. | Number | participants |
|
| Molecular Breast Imaging Prior to Study Entry | Number | participants |
|
| Breast Density of Participants with No Prior Mammogram | Number | participants |
|
| Molecular Breast Imaging Alone |
For this reporting arm, the interpretation and analysis was done with gamma imaging only. |
|
|
|
| Secondary | Specificity | Specificity measures the percentage of negatives which are correctly identified as such. | The analysis population only included participants with a verified negative cancer status at 12 months after the initial screening (mammography and MBI). | Posted | Number | 95% Confidence Interval | percentage of true negatives | Within 21 days of mammography |
|
|
|
|
| Secondary | Sensitivity for All Cancers Diagnosed | Sensitivity measures the percentage of actual positives which are correctly identified as such. | 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. | Posted | Number | 95% Confidence Interval | percentage of actual positives | Within 21 days of mammography |
|
|
|
|
| Secondary | Recall Rate | Recall rate was defined as the percentage of participants recalled for follow-up studies initiated because of abnormal findings with mammography or MBI. | The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and MBI). | Posted | Number | 95% Confidence Interval | percentage of participants | 12 months after mammography and MBI |
|
|
|
|
| Secondary | Biopsy Rate | Biopsy rate = number of participants who had a biopsy/number of number of participants analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 months after mammography and MBI |
|
|
|
|
| 0 |
| 1,585 |
| 0 |
| 1,585 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| <0.0001 |
| No |
| Superiority or Other |
| 0.004 |
| No |
| Superiority or Other |
| <0.001 |
| No |
| Superiority or Other |
| <0.001 |
| No |
| Superiority or Other |