What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as contrast-enhanced mammography, endocrine therapy, and chemotherapy, have various side effects. Contrast agents used in imaging can cause mild adverse events in some patients. Endocrine therapies like tamoxifen and aromatase inhibitors can lead to toxicities such as bone density loss, fractures, and cardiovascular risks. Chemotherapy agents, including doxorubicin, may result in neutropenia, anemia, thrombocytopenia, and febrile neutropenia. These side effects should be discussed with a healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer that enhance visualization and target specific cancer characteristics. For instance, ado-trastuzumab emtansine (T-DM1) and fam-trastuzumab deruxtecan (T-DXd) are approved for HER2-positive metastatic breast cancer, offering targeted therapy that can be monitored for efficacy using advanced imaging techniques. Additionally, the use of contrast agents in imaging, such as in contrast-enhanced mammography, helps in highlighting areas of increased blood flow, potentially indicating cancer presence. These advancements in both therapeutic and diagnostic approaches aim to improve detection, monitoring, and treatment outcomes for breast cancer patients.

What other types of research exist?

Promising novel alternatives to contrast-enhanced mammography for breast cancer patients include echo-planar MR imaging and dynamic contrast-enhanced ultrasonography. Echo-planar MR imaging quantifies dynamic enhancement of breast lesions and correlates with histologic findings and microvessel density, showing high sensitivity (86%) and specificity (93%) for diagnosing malignancy. Dynamic contrast-enhanced ultrasonography can predict the probability of lymphatic metastasis and provides noninvasive markers of angiogenesis, making it a useful tool for monitoring anti-angiogenic therapies.

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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

No Placebo-Only Group

Summary

This trial aims to see if using contrast-enhanced mammography (CEM) can better detect breast cancer in women who have had it before. CEM uses a special dye to make cancerous tissues more visible on the mammogram. The goal is to improve detection rates without significantly increasing false positives. Contrast-enhanced mammography (CEM) is an imaging tool for breast cancer detection that combines conventional mammography with a special dye to improve cancer detection.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cancer Detection

Secondary study objectives

Reader Validation

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 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

0 / 6Eligibility criteria met

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.