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Study the Role of Positron Emission Mammography in Pre-surgical Planning for Breast Cancer

Phase 4
Waitlist Available
Led By Etta Pisano, MD, FACR
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 up to 5 years
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Group I: 1 PEMActive Control1 Intervention
Group II: 2 MRIActive Control1 Intervention

Find a Location

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
Etta Pisano, MD, FACRPrincipal InvestigatorUniversity of North Carolina School of Medicine, Chapel Hill, NC
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
Wendie A Berg, MD, Ph.DStudy DirectorAmerican Radiology Services, Johns Hopkins Greenspring, Lutherville, MD
Kathy Schilling, MDPrincipal InvestigatorBoca Raton Community Hospital, Boca Raton, FL
1 Previous Clinical Trials
196 Total Patients Enrolled
1 Trials studying Breast Cancer
196 Patients Enrolled for Breast Cancer
Marie Tartar, MDPrincipal InvestigatorScripps Cancer Center, San Diego, CA
Linda Hovanessian Larsen, MDPrincipal InvestigatorUSC Norris Cancer Center
~24 spots leftby Jan 2026
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