Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| BUMC-H-27136 | Other Identifier | BUMC IRB | |
| W81XWH-06-1-0309 | Other Identifier | funding number | |
| 05063002 | Other Identifier | ||
| HRPO #A-13777.2 | Other Identifier | DoD |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| United States Department of Defense | FED |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Screening tests may help doctors find cancer cells early and plan better treatment for breast cancer. It is not yet known whether positron emission mammography is more effective than standard mammography in finding breast tumors.
PURPOSE: This phase III trial is studying positron emission mammography to see how well it works compared with standard mammography in women undergoing screening mammogram at Boston Medical Center.
OBJECTIVES:
OUTLINE: Patients undergo a conventional two-view mammogram and positron emission mammography (PEM). Immediately following treatment, patients complete a questionnaire on their satisfaction with the standard mammogram and the positron emission mammography.
After completion of study treatment, patients are followed annually.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| positron emission mammography | Experimental | questionnaire administration digital mammography positron emission mammography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionnaire administration | Other | Questionnaire regarding patient satisfaction with mammogram experience and with positron emission mammography experience. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" Call-back in Mammography vs Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" in Positron Emission Mammography | Number of participants called back due to Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" Mammogram compared to number of patients with Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" in positron emission mammography Breast Imaging Assessment Reporting and Data System (BI-RADS) Scale: 0 = Inconclusive for malignancy; call-back in mammography
| immediately at completion of mammogram |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction Level as Pertaining to Comfort and Pain for Each Study | Number of participants satisfied with positron emission mammography with regard to comfort and pain for each study 1-7 rating scale, Entries from 1-4 considered Satisfied. Entries 5-7 considered not Satisfied. | One month |
Not provided
Inclusion criteria:
DISEASE CHARACTERISTICS:
Scheduled to undergo screening mammogram at one of the Boston Medical Center-affiliated primary care clinics and meets 1 of the following criteria:
PATIENT CHARACTERISTICS:
Has 1 of the following racial or ethnic backgrounds based on the patient's country of birth or the mother and father's country of birth:
PRIOR CONCURRENT THERAPY:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gustavo Mercier, MD, PhD | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University Cancer Research Center | Boston | Massachusetts | 02118 | United States |
Individual participant data is not useful.
Not provided
Not provided
Not provided
Not provided
Not provided
193 participants were enrolled onto this study between 4/8/2009 through 5/31/2012 in the Breast Center.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm Positron Emission Mamm, Mammogram and Questionnaire | questionnaire administration positron emission mammography digital mammography: standard screening mammogram questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with positron emission mammography experience. positron emission mammography: one-time PEM to compare recall rates with that of standard mammogram |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Eligible participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Positron Emission Mammography (PEM), Mammography, Questionaire | questionnaire administration digital mammography positron emission mammography questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with positron emission mammography experience. digital mammography: standard screening mammogram positron emission mammography: one-time positron emission mammography to compare recall rates with that of standard mammogram |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age of the subjects must be greater than or equal to 18 years of age. |
| 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 | Frequency of Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" Call-back in Mammography vs Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" in Positron Emission Mammography | Number of participants called back due to Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" Mammogram compared to number of patients with Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" in positron emission mammography Breast Imaging Assessment Reporting and Data System (BI-RADS) Scale: 0 = Inconclusive for malignancy; call-back in mammography
| Number of participants who completed protocol with complete data set | Posted | Number | participants | immediately at completion of mammogram |
|
There were no adverse events during the course of this study
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm PEM, Mammography and Questionnaire | questionnaire administration positron emission mammography digital mammography: standard screening mammogram questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with PEM experience. positron emission mammography: one-time PEM to compare recall rates with that of standard mammogram |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gustavo Mercier, House Radiologist | Boston Medical Center | 617-638-6610 | gustavo.mercier@bmc.org |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
PEM
Not provided
Not provided
Not provided
Not provided
| digital mammography | Procedure | standard screening mammogram |
|
| positron emission mammography | Procedure | one-time positron emission mammography to compare recall rates with that of standard mammogram |
|
| technical difficulties |
|
| Count of Participants |
| Participants |
|
| Sex/Gender, Customized | The gender of the patient must be female per protocol. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Hispanic/Non-Hispanic eligible | Count of Participants | Participants |
|
| Race (NIH/OMB) | Caucasian African American | Count of Participants | Participants |
|
| Region of Enrollment | Boston, Massachusetts, USA | Count of Participants | Participants |
|
| Pregnancy status | Only non-pregnant patients are allowed to participate. | Count of Participants | Participants |
|
| No prior history of cancer in previous 5 years | Number | participants |
|
questionnaire administration positron emission mammography
digital mammography: standard screening mammogram
questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with positron emission mammography experience.
positron emission mammography: one-time positron emission mammography to compare recall rates with that of standard mammogram
|
|
| Secondary | Patient Satisfaction Level as Pertaining to Comfort and Pain for Each Study | Number of participants satisfied with positron emission mammography with regard to comfort and pain for each study 1-7 rating scale, Entries from 1-4 considered Satisfied. Entries 5-7 considered not Satisfied. | All participants who completed imaging and questionnaires. | Posted | Number | participants | One month |
|
|
|
| 0 |
| 188 |
| 0 |
| 188 |
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| Title | Measurements |
|---|---|
|
| Not Satisfied with the Experience: PEM |
|