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Contrast-Enhanced Mammography for Breast Abnormalities
Phase 4
Recruiting
Led By Margarita L Zuley, MD
Research Sponsored by Margarita Louise Zuley
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is ≥30 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 5
Awards & highlights
Study Summary
This trial is testing whether adding a contrast-enhanced mammography (CEM) procedure to the standard mammography procedure can reduce the number of times a biopsy is recommended for actually benign cases by at least 20%.
Who is the study for?
This trial is for women aged 30 or older with suspicious breast abnormalities scheduled for a biopsy. It's not suitable for pregnant or breastfeeding women, those on chemotherapy, with reduced kidney function (eGFR < 45), known allergies to iodinated contrast, or who have a breast implant in the affected breast.Check my eligibility
What is being tested?
The study tests if Contrast-Enhanced Mammography (CEM) using Iodinated Contrast Media can reduce unnecessary biopsies in cases rated BI-RADS 4A/4B while maintaining high cancer detection rates. Participants will undergo CEM before their planned biopsy to evaluate its effectiveness.See study design
What are the potential side effects?
Potential side effects may include reactions to the iodinated contrast used during CEM such as rash, itching, or more severe allergic responses. Kidney function might also be affected due to the contrast media.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 30 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ year 5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 5
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Negative Predictive Value (NPV)
Secondary outcome measures
Positive Predictive Value of biopsies performed (PPV3)
Other outcome measures
Frequencies
Positive predictive value of biopsy recommendations (PPV2)
Trial Design
1Treatment groups
Experimental Treatment
Group I: contrast enhanced mammographyExperimental Treatment2 Interventions
Women who have been recently diagnosed with a suspicious abnormality for which they have scheduled a breast biopsy and meet inclusion criteria will be invited to have a contrast enhanced mammography before their scheduled biopsy procedure.
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Who is running the clinical trial?
Margarita Louise ZuleyLead Sponsor
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,924,050 Total Patients Enrolled
939 Trials studying Breast Cancer
1,541,505 Patients Enrolled for Breast Cancer
Margarita L Zuley, MDPrincipal InvestigatorUniversity of Pittsburgh
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently receiving chemotherapy for cancer.You have a breast implant in the breast being studied.My kidney function is low, with an eGFR below 45.I cannot or do not want to give informed consent.I am a woman.You are currently breastfeeding.I am scheduled for a biopsy due to a suspicious finding in my breast.I am 30 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: contrast enhanced mammography
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the scope of participation in this experiment?
"Affirmative. As per clinicaltrials.gov, this investigation is actively seeking participants for engagement; first listed on February 1st 2022 and last updated July 6th of the same year. 1855 candidates are needed from one medical centre to take part in this experiment."
Answered by AI
What are the safety risks involved with contrast-enhanced mammography?
"The safety of contrast enhanced mammography is ranked a 3, as it has already been approved by the authorities after four phases of clinical trials."
Answered by AI
Are there any remaining openings for participants in this clinical experiment?
"Clinicaltrials.gov reveals that this experiment is presently recruiting participants, with the initial posting date occurring on February 1st 2022 and the page last being edited on July 6th 2022."
Answered by AI
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