Tomosynthesis vs. Contrast-Enhanced Mammography for Breast Cancer
(TOCEM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a contrast-enhanced mammogram, a type of imaging test, can detect breast cancer more effectively than the current 3D mammogram while maintaining a low rate of false alarms. It targets women who have previously had breast cancer and are currently symptom-free. Ideal candidates for this trial are women who have had breast cancer in the past, are now symptom-free, and have undergone at least one routine mammogram since completing treatment. As an unphased trial, it offers participants the chance to contribute to the advancement of breast cancer detection methods.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are actively being treated for cancer with chemotherapy, you cannot participate in the trial.
What prior data suggests that contrast-enhanced mammography is safe for breast cancer screening?
Research has shown that the FDA approved contrast-enhanced mammography (CEM) for diagnostic use in 2011, confirming its safety. Studies have found CEM to be highly effective at detecting breast cancer, particularly in women with dense breast tissue. Importantly, these studies did not find any significant increase in side effects when using CEM compared to standard imaging methods. This information reassures those considering participation in a clinical trial involving this technique.12345
Why are researchers excited about this trial?
Researchers are excited about contrast-enhanced mammography because it offers a new way to screen for breast cancer by highlighting areas of increased blood supply, which often indicate the presence of tumors. Unlike standard mammograms, which only capture images of the breast tissue, this technique uses a special dye that makes it easier to spot potential issues. This could lead to more accurate detection and fewer false positives, meaning women might avoid unnecessary anxiety and follow-up procedures. By combining this method with 3D mammography, doctors hope to improve early detection rates and outcomes for patients.
What evidence suggests that contrast-enhanced mammography is effective for breast cancer detection?
Studies have shown that contrast-enhanced mammography (CEM), which participants in this trial will receive, helps detect breast cancer more effectively. For example, one study found that CEM detected cancer in 15.5 out of every 1,000 women, similar to the detection rate of MRI scans. Another study reported a detection rate of 13.1 per 1,000 cases. Additionally, a different trial showed an even higher detection rate of 23.9 per 1,000 in women at higher risk. These findings suggest that CEM could be a powerful tool for early breast cancer detection, even when compared to other advanced methods.13678
Who Is on the Research Team?
Wendie Berg, MD, PhD
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Annual Screening
Participants undergo three rounds of annual screening with contrast-enhanced mammography and tomosynthesis
Follow-up
Participants are monitored for cancer detection and false positives
What Are the Treatments Tested in This Trial?
Interventions
- Contrast-enhanced mammogram
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wendie Berg
Lead Sponsor
Breast Cancer Research Foundation
Collaborator