Breast Cancer
Conditions
Keywords
breast cancer
Brief summary
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.
Detailed description
OBJECTIVES: * To install the breast Positron Emission Mammography system and to test and ensure its compliance with all regulatory agencies including the American College of Radiology and the Food and Drug Administration. * To measure and compare the number of call-backs for positron emission mammography (PEM) imaging and conventional mammography. * To measure and compare patient satisfaction for both conventional mammography and positron emission mammography in terms of comfort and pain. 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.
Interventions
OTHERquestionnaire administration
Questionnaire regarding patient satisfaction with mammogram experience and with positron emission mammography experience.
PROCEDUREdigital mammography
standard screening mammogram
PROCEDUREpositron emission mammography
one-time positron emission mammography to compare recall rates with that of standard mammogram
Sponsors
United States Department of Defense
Boston Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
PEM
Eligibility
Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
Yes
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: * Dense breast tissue * At high-risk for breast cancer 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: * Hispanic * Haitian Creole * African American * Caucasian PRIOR CONCURRENT THERAPY: * None specified
Exclusion criteria
* No history of breast cancer, palpable breast mass, abnormal nipple discharge, or other focal complaints warranting diagnostic mammogram
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | immediately at completion of mammogram | 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 1. = normal 2. = abnormal, with no malignancy 3. = abnormal, likely benign 4. = abnormal, likely malignant 5. = malignant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Level as Pertaining to Comfort and Pain for Each Study | One month | 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. |
Countries
United States
Participant flow
Recruitment details
193 participants were enrolled onto this study between 4/8/2009 through 5/31/2012 in the Breast Center.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 193 |
| Total | 193 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | missing documentation | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Pregnancy | 1 |
| Overall Study | technical difficulties | 2 |
Baseline characteristics
| Characteristic | Positron Emission Mammography (PEM), Mammography, Questionaire |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 182 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 185 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| No prior history of cancer in previous 5 years | 193 participants |
| Pregnancy status negative pregnancy status | 192 Participants |
| Pregnancy status pregnant status | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 113 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 80 Participants |
| Region of Enrollment United States | 193 Participants |
| Sex/Gender, Customized Female | 193 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 188 |
| serious Total, serious adverse events | 0 / 188 |
Outcome results
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 1. = normal 2. = abnormal, with no malignancy 3. = abnormal, likely benign 4. = abnormal, likely malignant 5. = malignant
Time frame: immediately at completion of mammogram
Population: Number of participants who completed protocol with complete data set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Arm Positron Emission Mammography and Questionnaire | 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 BI-RAD 0 Mammogram | 28 participants |
| Single Arm Positron Emission Mammography and Questionnaire | 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 BI-RAD 0 positron emission mammograph | 27 participants |
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.
Time frame: One month
Population: All participants who completed imaging and questionnaires.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Arm Positron Emission Mammography and Questionnaire | Patient Satisfaction Level as Pertaining to Comfort and Pain for Each Study | Satisfied With Experience: Mammogram | 165 participants |
| Single Arm Positron Emission Mammography and Questionnaire | Patient Satisfaction Level as Pertaining to Comfort and Pain for Each Study | Not Satisifed with Experience: Mammogram | 23 participants |
| Single Arm Positron Emission Mammography and Questionnaire | Patient Satisfaction Level as Pertaining to Comfort and Pain for Each Study | Satisfied with the Experience: PEM | 175 participants |
| Single Arm Positron Emission Mammography and Questionnaire | Patient Satisfaction Level as Pertaining to Comfort and Pain for Each Study | Not Satisfied with the Experience: PEM | 13 participants |