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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.5 years
Awards & highlights
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.5 years
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
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Breast cancer treatments work through various mechanisms to target and eliminate cancer cells. Surgery physically removes the tumor, while radiation therapy uses high-energy rays to destroy cancer cells.
Chemotherapy employs cytotoxic drugs to kill rapidly dividing cells, including cancer cells. Endocrine therapy blocks hormones like estrogen that fuel certain breast cancers, and targeted therapies, such as HER2 inhibitors, specifically attack cancer cells with particular genetic markers.
Understanding these mechanisms helps patients and doctors choose the most effective treatment plan. Imaging techniques like Contrast-Enhanced Mammography (CEM) enhance the detection and monitoring of breast cancer, ensuring timely and accurate treatment adjustments.
[Primary and adjuvant treatment of breast cancer: an update].Whole-breast irradiation with or without a boost for patients treated with breast-conserving surgery for early breast cancer: 20-year follow-up of a randomised phase 3 trial.Radiotherapy for early breast cancer.
[Primary and adjuvant treatment of breast cancer: an update].Whole-breast irradiation with or without a boost for patients treated with breast-conserving surgery for early breast cancer: 20-year follow-up of a randomised phase 3 trial.Radiotherapy for early breast cancer.
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Women aged 40-75 with very dense breasts.You have noticeable breast changes like a lump, nipple discharge, or nipple retraction, or you have been getting checked for a breast abnormality.You have a high risk of breast cancer due to genetic mutations, past radiation therapy to the chest before the age of 30, or a strong family history of breast cancer.Your kidneys are not working well, with an eGFR less than 45 mL/min.Women under 75 years old who are advised to have yearly MRI and mammogram screenings based on current guidelines.You are currently receiving treatment for cancer with chemotherapy, but not with oral hormone therapy like aromatase inhibitors or tamoxifen.Women with dense breasts and family history of breast cancer who are not considered at high risk starting at age 40 or ten years before the youngest relative's age, but not before age 30.You have breast implants.You are younger than 30 or older than 75 years old.Women with lobular carcinoma in situ diagnosed within the past year.You had breast surgery in the last year.If you are a woman who had breast cancer before age 50 or have dense breasts after being diagnosed with breast cancer, you cannot participate.
Research Study Groups:
This trial has the following groups:- Group 1: Contrast-enhanced mammography
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
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.
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