Tomosynthesis vs. Contrast-Enhanced Mammography for Breast Cancer

(TOCEM Trial)

Recruiting at 2 trial locations

Overseen by Wendie Berg, MD, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Wendie Berg

No Placebo Group

Trial Summary

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.

Research Team

Wendie Berg, MD, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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.

Treatment Details

Interventions

• Contrast-enhanced mammogram (Imaging)

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.

Participant Groups

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+