Contrast-Enhanced Mammography for Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen byOlena Weaver

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

This clinical trial investigates contrast-enhanced mammography (CEM) in detecting breast cancer. CEM is similar to standard mammography, but it includes an injection of an iodine-based contrast, which makes tissue and blood vessels more visible in scans. Diagnostic procedures, such as CEM, may increase the chance of finding breast cancers and decrease the risk of having unnecessary biopsies.

Research Team

Olena Weaver

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for women aged 18 or older with diagnosed invasive or in-situ breast cancer, referred to MD Anderson for imaging-based staging. Participants must be willing and able to consent. Exclusions include recent breast surgery, iodine contrast allergy, history of severe allergic reactions, kidney issues, hyperthyroidism, or detection of non-breast primary/metastatic cancer.

Inclusion Criteria

I am willing and able to give my consent to participate in the study.

I am a woman over 18 with highly suspicious breast imaging results.

I am a woman over 18 with breast cancer, diagnosed elsewhere, seeking staging at MD Anderson.

Exclusion Criteria

I have an overactive thyroid.

You are allergic to contrast agents containing iodine.

I had breast surgery less than 6 months ago.

See 3 more

Treatment Details

Interventions

Contrast-Enhanced Mammography (Procedure)
Digital Tomosynthesis Mammography (Procedure)
Iodinated Contrast Agent (Contrast Agent)

Trial OverviewThe study tests contrast-enhanced mammography (CEM) which uses an iodine-based contrast agent to improve the visibility of tissue and blood vessels on scans. The goal is to better detect breast cancers and potentially reduce unnecessary biopsies by comparing CEM with digital tomosynthesis mammography.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Diagnostic (CEM, DBT, medical record)Experimental Treatment4 Interventions

Patient receive iodinated contrast agent IV and undergo CEM. Patients who have not undergone DBT as part of their screening or diagnostic imaging within 3 month, undergo DBT. Patients medical records are reviewed.

Contrast-Enhanced Mammography is already approved in China for the following indications: