Contrast Enhanced Digital Mammography for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Breast Cancer
Contrast Enhanced Digital Mammography - Procedure
Eligibility
18+
Female
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Study Summary

This trial is testing how well contrast enhanced mammography can diagnose patients with suspicious breast findings. The hope is that it will help to reclassify findings that would otherwise require a biopsy.

Treatment Effectiveness

Study Objectives

12 Primary · 6 Secondary · Reporting Duration: Up to 1 year

Up to 1 year
False negative rate of CEM
False negative rate of MM
False negative rate of US
False positive rate of CEM
False positive rate of MM
False positive rate of US
Negative predictive value of CEM
Negative predictive value of MM
Negative predictive value of US
Positive predictive value of CEM
Positive predictive value of MM
Positive predictive value of US
Sensitivity of MM to classify a lesion as benign, probably benign, or suspicious
Sensitivity of US to classify a lesion as benign, probably benign, or suspicious
Sensitivity of contrast enhanced mammography (CEM) to classify a lesion as benign, probably benign, or suspicious
Specificity of CEM to classify a lesion as benign, probably benign, or suspicious
Specificity of MM to classify a lesion as benign, probably benign, or suspicious
Specificity of US to classify a lesion as benign, probably benign, or suspicious

Trial Safety

Trial Design

1 Treatment Group

Diagnostic (CEM)
1 of 1
Experimental Treatment

107 Total Participants · 1 Treatment Group

Primary Treatment: Contrast Enhanced Digital Mammography · No Placebo Group · N/A

Diagnostic (CEM)
Procedure
Experimental Group · 1 Intervention: Contrast Enhanced Digital Mammography · Intervention Types: Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Contrast Enhanced Digital Mammography
2019
N/A
~470

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
398 Previous Clinical Trials
131,041 Total Patients Enrolled
5 Trials studying Breast Cancer
607 Patients Enrolled for Breast Cancer
Lydia LiaoPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University

Eligibility Criteria

Age 18+ · Female Participants · 5 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 17th, 2021

Last Reviewed: October 9th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.