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Contrast Enhanced Digital Mammography for Breast Cancer

N/A
Waitlist Available
Led By Lydia Liao
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women with digital breast tomosynthesis and/or ultrasound assessments of Breast Imaging Reporting and Data System (BI-RADS) 4 and 5 lesions with recommendation of needle biopsy for tissue diagnosis.
Abnormal findings include masses, focal, global or developing asymmetries, architecture distortions, or > 1 cm of suspicious calcifications with or without associated ultrasound abnormal findings.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
False negative rate of CEM
False negative rate of MM
False negative rate of US
+9 more
Secondary outcome measures
Negative predictive value of CEM
Negative predictive value of MM
Negative predictive value of US
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (CEM)Experimental Treatment1 Intervention
Patients undergo contrast enhanced mammography prior to scheduled standard of care core needle biopsy of the breast on the same day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Contrast Enhanced Digital Mammography
2019
N/A
~570

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
442 Previous Clinical Trials
145,360 Total Patients Enrolled
5 Trials studying Breast Cancer
607 Patients Enrolled for Breast Cancer
Lydia LiaoPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the intent of this experimental protocol?

"The main outcome of this medical experiment, which is to be evaluated over the course of one year, will measure the False negative rate of MM. Additionally, secondary objectives include assessing Positive predictive value with CEM and US as well as Negative predictive values for both CEM and MM."

Answered by AI

Is participation in this research endeavor still open to qualified subjects?

"According to clinicaltrials.gov, this research initiative is not currently recruiting for participants. This study was initially listed on June 23rd 2020 with its last edit occurring on August 15th 2022; however, there are still 2289 other trials actively taking enrolments at present."

Answered by AI

Is it permissible for me to join this clinical examination?

"Participants that seek admittance to this clinical trial must have breast cancer and fall between 30 and 80 years of age. Currently, recruitment is underway for a total of 107 qualifying subjects."

Answered by AI

Is the eligibility age range for this trial inclusive of persons fifty years or older?

"The prerequisites for entry into this clinical trial stipulate that candidates must be aged between 30 and 80. Those under 18 years of age have 64 studies available, while those over 65 can choose from 2207 trials instead."

Answered by AI
~23 spots leftby Mar 2025