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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 24 months, 48 months, and 62 months

Awards & highlights

Study Summary

This trial will study if better breast cancer screening can be done with less false alarms.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 24 months, 48 months, and 62 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

False-positive recall rate

Incremental Cancer Detection Rate

Positive-predictive values

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.

Do I qualify?Apply below to find out

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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

69 Previous Clinical Trials

136,267 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

Frequently Asked Questions

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

Who is eligible to join this clinical experiment?

"To qualify for this clinical trial, participants must have been diagnosed with breast cancer and fall between the ages of 30-79. The total number of enrollees is expected to reach around 1500 individuals."

Answered by AI

Is enrollment currently open for this trial?

"Per the records on clinicaltrials.gov, this medical study is actively seeking out participants. It was initially posted on October 24th 2023 and recently updated on October 23rd of that same year."

Answered by AI

Does the study accept participants who are younger than 25?

"Patients eligible to enroll in this clinical trial must be within the age specification of 30 and 79. There are 388 trials for minors under 18, while 4897 exist for those over 65 years old."

Answered by AI

What is the geographic scope of this trial's implementation?

"Currently, the trial is enrolling participants in 3 Pennsylvania cities and 5 other spots across the country. To curtail travel obligations associated with participation, you should opt for a location that's closest to your current residence."

Answered by AI

How many individuals have enrolled in this research project?

"Yes, the clinicaltrials.gov page for this trial affirms that it is actively recruiting participants since October 24th, 2023. A total of 1500 patients must be sourced from 5 different medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Biennial CEM in Women With a Personal History of Breast Cancer

Wendie Berg 2023. "Biennial CEM in Women With a Personal History of Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06105749.

All > Her 2 Positive Breast Cancer > Paid Studies Pittsburgh