Tomosynthesis vs. Contrast-Enhanced Mammography for Breast Cancer

(TOCEM Trial)

Recruiting at 2 trial locations

Overseen By Allysa Quick, BS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Wendie Berg

Must not be taking: Chemotherapy

Disqualifiers: Kidney failure, Breast implants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

1647 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

Is tomosynthesis safe for breast cancer screening?

The research does not specifically address safety concerns for tomosynthesis, but it is widely used in breast cancer screening, suggesting it is generally considered safe for this purpose. ^{1 2 3 4 5}

How is contrast-enhanced mammography different from other breast cancer screening treatments?

Contrast-enhanced mammography is unique because it uses a special dye to highlight areas of the breast, potentially making it easier to spot cancer compared to traditional mammography, which can struggle with dense breast tissue. This method may offer clearer images and improve cancer detection in cases where standard mammograms are less effective. ^{1 2 6 7 8}

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

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.

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?

Group I: Contrast-enhanced mammogram Experimental Treatment 1 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

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

1. United States pubmed.ncbi.nlm.nih.gov

Breast Cancer Screening Using Tomosynthesis or Mammography: A Meta-analysis of Cancer Detection and Recall. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Cumulative Probability of False-Positive Results After 10 Years of Screening With Digital Breast Tomosynthesis vs Digital Mammography. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Incremental effect from integrating 3D-mammography (tomosynthesis) with 2D-mammography: Increased breast cancer detection evident for screening centres in a population-based trial. [2016]

4. Ireland pubmed.ncbi.nlm.nih.gov

Added value of one-view breast tomosynthesis combined with digital mammography according to reader experience. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Increased Cancer Detection Rate and Variations in the Recall Rate Resulting from Implementation of 3D Digital Breast Tomosynthesis into a Population-based Screening Program. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Breast tomosynthesis. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Characterization of lesions in dense breasts: Does tomosynthesis help? [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Agreement between digital breast tomosynthesis and pathologic tumour size for staging breast cancer, and comparison with standard mammography. [2019]