Trial Outcomes & Findings for Positron Emission Mammography and Standard Mammography in Women at High Risk of Breast Cancer (NCT NCT00896649)

Last Updated: 2017-05-09

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

193 participants

Primary outcome timeframe

immediately at completion of mammogram

Results posted on

2017-05-09

Participant Flow

193 participants were enrolled onto this study between 4/8/2009 through 5/31/2012 in the Breast Center.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	193
Overall Study COMPLETED	188
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Physician Decision	1
Overall Study Pregnancy	1
Overall Study missing documentation	1
Overall Study technical difficulties	2

Baseline Characteristics

Positron Emission Mammography and Standard Mammography in Women at High Risk of Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Positron Emission Mammography (PEM), Mammography, Questionaire n=193 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	182 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Sex/Gender, Customized Female	193 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	185 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	113 Participants n=5 Participants
Race (NIH/OMB) White	80 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	193 Participants n=5 Participants
Pregnancy status negative pregnancy status	192 Participants n=5 Participants
Pregnancy status pregnant status	1 Participants n=5 Participants
No prior history of cancer in previous 5 years	193 participants n=5 Participants

PRIMARY outcome

Timeframe: immediately at completion of mammogram

Population: Number of participants who completed protocol with complete data set

Outcome measures

Outcome measures
Measure	Single Arm Positron Emission Mammography and Questionnaire n=188 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
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
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 outcome

Timeframe: One month

Population: All participants who completed imaging and questionnaires.

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.

Outcome measures

Outcome measures
Measure	Single Arm Positron Emission Mammography and Questionnaire n=188 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
Patient Satisfaction Level as Pertaining to Comfort and Pain for Each Study Satisfied With Experience: Mammogram	165 participants
Patient Satisfaction Level as Pertaining to Comfort and Pain for Each Study Not Satisifed with Experience: Mammogram	23 participants
Patient Satisfaction Level as Pertaining to Comfort and Pain for Each Study Satisfied with the Experience: PEM	175 participants
Patient Satisfaction Level as Pertaining to Comfort and Pain for Each Study Not Satisfied with the Experience: PEM	13 participants

Adverse Events

Single Arm PEM, Mammography and Questionnaire

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

Gustavo Mercier, House Radiologist

Boston Medical Center

Phone: 617-638-6610

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place