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Biennial CEM Screening for Breast Cancer

N/A
Recruiting
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
Must not have
Women with a history of kidney failure or estimated glomerular filtration rate (eGFR) < 45 mL/min
Women who have had bilateral mastectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 24 months, 48 months, and 62 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if adding a special type of mammogram with a contrast dye to the regular 3D mammogram can better detect breast cancer in women who have had it before. The dye helps highlight cancerous areas, and the 3D images provide detailed views from different angles.

Who is the study for?
This trial is for asymptomatic women aged 30-79 with a history of breast cancer, at least one year post any breast cancer surgery or treatment, and scheduled for an annual mammogram. Excluded are those with stage 4 metastasis to certain areas, bilateral mastectomy, recent chemotherapy or MRI exams, implants in the breasts to be screened, kidney issues including failure or low filtration rate, pregnancy or lactation, single kidney possession, and severe iodinated contrast reactions.
What is being tested?
The study is testing if adding biennial contrast-enhanced mammography (CEM) to annual 3D mammography improves detection rates of breast cancer without significantly increasing false positives among women who have previously had breast cancer.
What are the potential side effects?
Potential side effects may include allergic reactions to the iodinated contrast used in CEM. Women with mild allergies can participate if pre-medicated but will be excluded if they're allergic to common pre-medications like Benadryl.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am a woman with kidney issues or my kidney filtering rate is below 45 mL/min.
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I have had both of my breasts surgically removed.
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My cancer has spread to my organs or brain.
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I am a woman currently undergoing chemotherapy for cancer.
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I have only one kidney.
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I do not have breast implants.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 24 months, 48 months, and 62 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 24 months, 48 months, and 62 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
False-positive recall rate
Incremental Cancer Detection Rate
Positive-predictive values

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: contrast-enhanced mammographyExperimental Treatment1 Intervention
Enrolled participants will receive a baseline contrast-enhanced mammography exam for breast cancer screening, along with their scheduled 3D mammography exam, then they will receive another CEM exam for breast cancer screening at 24 months after their baseline CEM exam, and then again at 48 months. All the while, participants will still receive their annual 3D mammography exam as per their usual routine care.

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
Common treatments for breast cancer include surgery, radiation therapy, chemotherapy, hormone therapy, and targeted therapy. Surgery involves removing the tumor, while radiation therapy uses high-energy rays to kill cancer cells. Chemotherapy employs drugs to destroy rapidly dividing cells, including cancer cells. Hormone therapy blocks hormones like estrogen that can promote cancer growth, and targeted therapy uses drugs to target specific molecules involved in cancer cell growth and survival. Contrast-enhanced mammography (CEM) enhances the visibility of breast tissues using contrast agents, improving the detection of abnormalities. These treatments are crucial for breast cancer patients as they offer multiple strategies to eliminate cancer cells, reduce recurrence, and improve survival rates.

Find a Location

Who is running the clinical trial?

Wendie BergLead Sponsor
3 Previous Clinical Trials
8,514 Total Patients Enrolled
3 Trials studying Breast Cancer
8,514 Patients Enrolled for Breast Cancer
Breast Cancer Research FoundationOTHER
71 Previous Clinical Trials
136,291 Total Patients Enrolled
41 Trials studying Breast Cancer
128,977 Patients Enrolled for Breast Cancer
Wendie Berg, MD, PhDPrincipal InvestigatorUniversity of Pittsburgh
3 Previous Clinical Trials
8,514 Total Patients Enrolled
3 Trials studying Breast Cancer
8,514 Patients Enrolled for Breast Cancer
~1000 spots leftby Dec 2029
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