A Study to Compare Positron Emission Mammography with Contrast-Enhanced Breast MRI for Detecting Breast Cancer
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
NCT ID: NCT02770586
Sponsor Protocol Number: 15-004872
About this study
The purpose of this study is to compare the detection sensitivity of positron emission mammography to contrast-enhanced breast MRI in women with a high suspicion of breast cancer.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Have recent imaging study (mammogram, tomosynthesis, MBI or ultrasound) interpreted as highly suspicious for malignancy or known biopsy-proven malignancy (BI-RADS Category 5 or 6 within 60 days prior to the MRI or Positron Emission Mammography study
- Scheduled or will be scheduled for clinically indicated contrast-enhanced breast MRI examination
- PEM must be performed within 5 business days, prior to or following the clinical MRI
- Participant has signed the study-specific informed consent prior to registration
- Age 25 or older
Exclusion Criteria
- Unable to understand and sign the consent form
- Pregnant or lactating
- Physically unable to lie prone for ~20 minutes
- Undergone bilateral mastectomy
- Weight more than 300 lbs (weight limit on PEM table)
- Have contraindications to the clinical MRI examination
- Scheduled to undergo breast biopsy or surgery in the time period between the PEM and MRI studies
More information
Publications
Publications are currently not available