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Imaging

Tomosynthesis vs. Contrast-Enhanced Mammography for Breast Cancer (TOCEM Trial)

N/A
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
Must not have
Women who have had bilateral mastectomy
Women with a history of prior iodinated contrast reaction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights

Summary

This trial will compare cancer detection rates of two types of mammograms, one with and one without contrast enhancement.

Who is the study for?
This trial is for asymptomatic women aged 30-85 in Western Pennsylvania who have a personal history of breast cancer and have completed at least one routine mammogram post-treatment. It's not for those with current breast symptoms, kidney failure, past reactions to iodinated contrast, breast implants, pregnant or nursing women, bilateral mastectomy patients, or those undergoing chemotherapy.Check my eligibility
What is being tested?
The study is testing if contrast-enhanced mammography can detect breast cancer more effectively than the combination of mammography and tomosynthesis without significantly increasing false-positive results in women who've had breast cancer before.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to the contrast agent used in the enhanced mammograms. Kidney function could be affected due to the contrast material; therefore, individuals with pre-existing kidney issues are excluded.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had both of my breasts surgically removed.
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I have had a reaction to iodine-based contrast before.
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I am a woman with kidney issues or my kidney function is low.
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I am a woman currently undergoing chemotherapy for cancer.
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I have a lump or other symptoms in my breast.
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I have implants in my breasts.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 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
Cancer Detection
Secondary outcome measures
Reader Validation

Trial Design

1Treatment groups
Experimental Treatment
Group I: Contrast-enhanced mammogramExperimental Treatment1 Intervention
All women will receive both 3D mammography and contrast-enhanced mammography for breast cancer screening; the order of interpretation will vary for each of two radiologists

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. Contrast-enhanced mammography, a diagnostic tool, improves visualization of breast tissue by using contrast agents to highlight areas of increased blood flow, which may indicate the presence of cancer. This method helps in early detection and accurate diagnosis, which is crucial for effective treatment planning. Understanding these mechanisms allows patients to appreciate the importance of early and precise detection, leading to better treatment outcomes and potentially improved survival rates.
Quantification of tumor angiogenesis with contrast-enhanced x-ray imaging in preclinical studies: a review.Prediction of Target-Drug Therapy by Identifying Gene Mutations in Lung Cancer With Histopathological Stained Image and Deep Learning Techniques.Molecular imaging for monitoring treatment response in breast cancer patients.

Find a Location

Who is running the clinical trial?

Wendie BergLead Sponsor
3 Previous Clinical Trials
8,367 Total Patients Enrolled
3 Trials studying Breast Cancer
8,367 Patients Enrolled for Breast Cancer
Breast Cancer Research FoundationOTHER
69 Previous Clinical Trials
136,083 Total Patients Enrolled
41 Trials studying Breast Cancer
128,830 Patients Enrolled for Breast Cancer
Wendie Berg, MD, PhD5.01 ReviewsPrincipal Investigator - University of Pittsburgh
University of Pittsburgh
3 Previous Clinical Trials
8,367 Total Patients Enrolled
3 Trials studying Breast Cancer
8,367 Patients Enrolled for Breast Cancer

Media Library

Contrast-enhanced mammogram (Imaging) Clinical Trial Eligibility Overview. Trial Name: NCT04085510 — N/A
Breast Cancer Research Study Groups: Contrast-enhanced mammogram
Breast Cancer Clinical Trial 2023: Contrast-enhanced mammogram Highlights & Side Effects. Trial Name: NCT04085510 — N/A
Contrast-enhanced mammogram (Imaging) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04085510 — N/A
~361 spots leftby Dec 2025
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