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

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
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights

TOCEM Trial 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.

TOCEM Trial 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

TOCEM 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

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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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the estimated enrollment rate for this experiment?

"Affirmative. According to the info on clinicaltrials.gov, this study is still seeking participants which it initially posted for in October 2019 and more recently updated in September 2022. The trial requires 1650 people from 3 different locations to take part."

Answered by AI

May I qualify to take part in this medical trial?

"In order to be eligible, individuals must have a diagnosis of breast cancer and be aged between 30 and 85. This trial aims to recruit approximately 1650 participants."

Answered by AI

Are there any opportunities still available for participation in this experiment?

"That is correct. Clinicaltrials.gov attests that this investigation, which was first advertised on October 23rd 2019, is actively recruiting participants. 1,650 individuals are needed from three distinct clinical locations to take part in the trial."

Answered by AI

Does this research endeavor offer opportunities for individuals aged 45 and above?

"This particular clinical research effort is searching for participants between the ages of 30 and 85. Those younger than that age threshold can look to 370 alternative trials, while those older have access to 4,568 studies."

Answered by AI
~406 spots leftby Dec 2025