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Contrast-Enhanced Mammography for Breast Cancer Screening (SCEMAM Trial)

Phase 4
Waitlist Available
Led By Wendie Berg, MD, PhD
Research Sponsored by Wendie Berg
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Screening 3 weeks
Treatment Varies
Follow Up 1.5 years
Awards & highlights

SCEMAM Trial Summary

This trial is testing whether contrast-enhanced mammography (CEM) is as effective as screening breast MRI for women for whom MRI is not feasible.

Who is the study for?
This trial is for women aged 30-75 with dense breasts or high breast cancer risk due to genetics, family history, or past chest radiation. It's also for those recommended for MRI screening but can't have it due to factors like claustrophobia or implants. Women with a personal history of early breast cancer are eligible too. Exclusions include current breast symptoms, poor kidney function, active chemotherapy (except oral endocrine therapy), having breast implants, being under 30 or over 75 years old, and recent pregnancy/breastfeeding or breast surgery.Check my eligibility
What is being tested?
The study tests if contrast-enhanced mammography (CEM) can be an alternative to MRI for breast cancer screening in women who cannot undergo MRI. CEM uses standard mammography equipment plus an intravenous iodinated contrast agent similar to what's used in CT scans.See study design
What are the potential side effects?
Potential side effects may include reactions to the iodinated contrast media such as allergic reactions ranging from mild itching to severe responses like difficulty breathing; kidney issues especially if pre-existing conditions are present; and discomfort from the procedure itself.

SCEMAM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cancer Detection Rate
Secondary outcome measures
False Positive Recall Rates

SCEMAM Trial Design

1Treatment groups
Experimental Treatment
Group I: Contrast-enhanced mammographyExperimental Treatment2 Interventions
Women who meet criteria for supplemental screening MRI, but who are unable to have MRI for medical/access/cost reasons, will be invited to have screening with contrast-enhanced mammography. Women will also have standard-of-care mammography/tomosynthesis per usual clinical practice.

Find a Location

Who is running the clinical trial?

Wendie BergLead Sponsor
3 Previous Clinical Trials
9,413 Total Patients Enrolled
3 Trials studying Breast Cancer
9,413 Patients Enrolled for Breast Cancer
PA Breast Cancer CoalitionUNKNOWN
Wendie Berg, MD, PhD5.01 ReviewsPrincipal Investigator - University of Pittsburgh
University of Pittsburgh
3 Previous Clinical Trials
9,413 Total Patients Enrolled
3 Trials studying Breast Cancer
9,413 Patients Enrolled for Breast Cancer

Media Library

Contrast-enhanced mammography Clinical Trial Eligibility Overview. Trial Name: NCT04764292 — Phase 4
Breast Cancer Research Study Groups: Contrast-enhanced mammography
Breast Cancer Clinical Trial 2023: Contrast-enhanced mammography Highlights & Side Effects. Trial Name: NCT04764292 — Phase 4
Contrast-enhanced mammography 2023 Treatment Timeline for Medical Study. Trial Name: NCT04764292 — Phase 4

Frequently Asked Questions

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

Does the research allow for participants aged 30 or younger?

"Eligible participants of this research must be between 30 and 75 years old. For those under 18, there are 74 relevant trials while 2505 studies focus on elderly patients."

Answered by AI

What is the capacity of this trial for enrolling participants?

"That is correct. According to information published on clinicaltrials.gov, this study started accepting participants on February 15th 2021 and was last modified on September 2nd 2022. 600 patients are needed across 3 different sites for the trial's completion."

Answered by AI

Is it still possible to join this investigative research?

"Affirmative. According to the information provided on clinicaltrials.gov, this medical research is actively recruiting participants since its initial posting on February 15th 2021. The study seeks a total of 600 patients from 3 different sites and was most recently updated on September 2nd 2022."

Answered by AI

Is Contrast-enhanced mammography a risk-free procedure for patients?

"As this Phase 4 trial indicates Contrast-enhanced mammography has already been approved, our team at Power assessed its safety with a score of 3."

Answered by AI

Is it possible for me to partake in this clinical research study?

"This trial is looking to enrol 600 individuals aged between 30 and 75, who have a current diagnosis of breast cancer. Furthermore, applicants must also fit the following criteria: Women endowed with a pathogenic mutation putting them at elevated risk for developing this disease; prior chest radiation therapy received 8 years earlier as well as before age 30 or lifetime risks estimated at above 20%, females possessing extremely dense breasts in the 40-75 year range (7% of screened population), women diagnosed with lobular carcinoma in situ post one year from detection (0.06% of screening population), those who had personal histories of having their malignancy identified by age"

Answered by AI
~0 spots leftby May 2024