Tomosynthesis vs. Contrast-Enhanced Mammography for Breast Cancer

(TOCEM Trial)

Not currently recruiting at 2 trial locations
BD
NL
WB
AQ
Overseen ByAllysa Quick, BS
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Wendie Berg
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

WB

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

I am a woman aged 30-85 with a history of breast cancer and have had a mammogram after treatment.

Exclusion Criteria

I have had a reaction to iodine-based contrast before.
I am a woman with kidney issues or my kidney function is low.
I have had both of my breasts surgically removed.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Annual Screening

Participants undergo three rounds of annual screening with contrast-enhanced mammography and tomosynthesis

36 months
3 annual visits

Follow-up

Participants are monitored for cancer detection and false positives

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Contrast-enhanced mammogram
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Contrast-enhanced mammogramExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wendie Berg

Lead Sponsor

Trials
4
Recruited
10,000+

Breast Cancer Research Foundation

Collaborator

Trials
79
Recruited
40,500+

Citations

Screening for Breast Cancer with Contrast-enhanced ...Adding contrast-enhanced mammography to digital breast tomosynthesis significantly increased early breast cancer detection alongside a 13% increase in the ...
Contrast-Enhanced Mammography in Breast Cancer ScreeningThe overall cancer detection rate was 15.5 per 1000 women, which is similar to MRI. Follow-up data for these patients are currently pending. Among a small ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39058970/
Prospective Study of Supplemental Screening With ...A pilot trial demonstrates a supplemental cancer detection rate of 23.9 per 1000 in women at an elevated risk for breast cancer.
Evaluating ten years of breast cancer screening with ...The cancer detection rate for CEM was 13.1 per 1,000 cases, and the AUC was 0.923. Conclusions. CEM is a viable breast cancer screening method for women with ...
Diagnostic Accuracy of Screening Contrast-enhanced ...Adjunct US yielded an increased cancer detection rate of approximately 3.5 per 1000 screenings, although with a substantially increased number ...
What is Contrast Enhanced Mammography?Contrast enhanced mammography was FDA approved for diagnostic mammograms in 2011. Women who were called back for additional testing after an ...
Contrast Enhanced Digital MammographyThe sensitivity of mammography for the detection of cancer in screening populations ranges from approximately 60% to more than 90% depending on breast density, ...
Contrast-Enhanced Mammography: Bridging the research ...Interim results have demonstrated that supplemental contrast imaging facilitate earlier cancer detection in women with dense breasts, without significant ...
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