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Contrast-Enhanced Mammography for Breast Cancer

N/A

Waitlist Available

Led By Olena Weaver

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female patients 18 years of age or older with known invasive or in-situ breast cancer (BC) diagnosed at an outside facility and presenting to MD Anderson for staging with imaging

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

Study Summary

This trial looks at whether a kind of mammogram that uses an iodine-based contrast can help find breast cancer. The contrast makes it easier to see tissue and blood vessels in scans. This could help avoid unnecessary biopsies.

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

Potential side effects may include allergic reactions to the iodinated contrast agent used in CEM such as rash or itching; more serious but rare risks involve kidney function impairment and thyroid gland disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 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

Accuracy of contrast enhanced mammography (CEM) for incremental cancer detection in the ipsilateral and contralateral breasts

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Digital Tomosynthesis Mammography

2017

N/A

~140

Iodinated Contrast Agent

2021

N/A

~90

Contrast-Enhanced Mammography

2021

N/A

~90

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,971 Previous Clinical Trials

1,787,127 Total Patients Enrolled

148 Trials studying Breast Cancer

63,286 Patients Enrolled for Breast Cancer

Olena WeaverPrincipal InvestigatorM.D. Anderson Cancer Center

3 Previous Clinical Trials

317 Total Patients Enrolled

Media Library

Contrast-Enhanced Mammography Clinical Trial Eligibility Overview. Trial Name: NCT05036083 — N/A

Breast Cancer Research Study Groups: Diagnostic (CEM, DBT, medical record)

Breast Cancer Clinical Trial 2023: Contrast-Enhanced Mammography Highlights & Side Effects. Trial Name: NCT05036083 — N/A

Contrast-Enhanced Mammography 2023 Treatment Timeline for Medical Study. Trial Name: NCT05036083 — N/A

Frequently Asked Questions

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

What therapeutic applications does an Iodinated Contrast Agent typically facilitate?

"Iodinated Contrast Agent is a useful resource for treating communicable diseases, implementing antiseptic measures, and preventing infection in minor wounds."

Answered by AI

Are there any vacancies in the current trial available to prospective participants?

"At the moment, this medical trial is no longer accepting participants. According to records, it was originally posted on March 19th 2021 and last updated June 29th 2022. If you are searching for other trials related to breast carcinoma there exists 4571 active studies; 15 more if looking specifically at Iodinated Contrast Agents."

Answered by AI

To what magnitude is the participant pool of this research?

"This research project is not currently searching for applicants. Initially posted on March 19th 2021, the last update to this trial was June 29th 2022. However, if you are seeking other clinical trials, there are 4571 studies actively recruiting patients with breast carcinoma and 15 investigations looking for participants using an Iodinated Contrast Agent."

Answered by AI

Has research been conducted to evaluate the efficacy of Iodinated Contrast Agent?

"At present, the medical community has 15 ongoing research initiatives regarding Iodinated Contrast Agent. Two of those have made it to Phase 3 testing and are being conducted across 37 locations in Sevilla & Vizcaya."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Contrast-Enhanced Mammography for Breast Cancer Staging in Patients Referred for a Second Opinion

2021. "Contrast-Enhanced Mammography for Breast Cancer Staging in Patients Referred for a Second Opinion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05036083.