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1 PEM for Breast Cancer
Phase 4
Waitlist Available
Led By Lorraine Tafra, MD
Research Sponsored by Naviscan PET Systems
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within the first 30 days (plus or minus 7 days) after surgery
Awards & highlights
Study Summary
Women with newly diagnosed breast cancer anticipating breast-conserving surgery are enrolled into the study and will undergo both high-resolution positron emission mammographic (PEM) imaging and contrast-enhanced magnetic resonance imaging (MRI) of the breast(s). The purpose of this study is to determine changes in surgical management resulting from PEM or MRI imaging as compared to conventional imaging and to determine if the changes were appropriate with histopathology as gold standard.
Eligible Conditions
- Breast Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within the first 30 days (plus or minus 7 days) after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within the first 30 days (plus or minus 7 days) after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The for this study will be measured by evidence of malignancy on PEM and/or MRI, confirmed by core biopsy or surgery.
Secondary outcome measures
Risk of false positive examinations with either PEM or MRI imaging with surgery as gold standard
Trial Design
2Treatment groups
Active Control
Group I: 1 PEMActive Control1 Intervention
Group II: 2 MRIActive Control1 Intervention
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Who is running the clinical trial?
Naviscan PET SystemsLead Sponsor
1 Previous Clinical Trials
22 Total Patients Enrolled
1 Trials studying Breast Cancer
22 Patients Enrolled for Breast Cancer
Certus International, Inc.OTHER
Lorraine Tafra, MDPrincipal InvestigatorAnne Arundel Medical Center, MD
1 Previous Clinical Trials
664 Total Patients Enrolled
1 Trials studying Breast Cancer
664 Patients Enrolled for Breast Cancer
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