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CESM for Breast Cancer Detection

N/A

Recruiting

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

Women presenting to MDACC for the evaluation of PND as the main or accompanying symptom

Age 25-85 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trial looks at using CESM to examine nipple discharge to see if it's more effective than standard mammography in detecting breast cancer.

Who is the study for?

This trial is for women aged 25-85 with abnormal nipple discharge, who can have an IV placed and tolerate iodine contrast. It's not for those who've had recent breast biopsies or surgery near the nipple, known breast cancer, inflammation in the breast, are pregnant or breastfeeding within 6 months, allergic to iodine contrast, severe allergies of any kind without prior safe iodine contrast use, or kidney issues.Check my eligibility

What is being tested?

The study tests if Contrast Enhanced Spectral Mammography (CESM), which uses an injected dye to make scans clearer than standard mammograms, is more effective at diagnosing causes of nipple discharge and detecting breast cancer.See study design

What are the potential side effects?

Potential side effects include reactions to the iodinated contrast agent used during CESM such as allergic reactions ranging from mild (itching, rash) to severe (trouble breathing), and possible kidney function impact.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am a woman seeking evaluation for nipple discharge as a primary or secondary symptom.

Select...

I am between 25 and 85 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sensitivity of contrast enhancement of contrast enhanced spectral mammography (CESM)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (CESM, DBT)Experimental Treatment4 Interventions

Patients receive iodine-based contrast agent IV then undergo CESM over 10-15 minutes. Patients who have not undergone standard of care DBT within 3 months from the study, also undergo DBT.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Contrast Enhanced Digital Mammography

2019

N/A

~570

Digital Tomosynthesis Mammography

2017

N/A

~140

Iodine

FDA approved

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,981 Previous Clinical Trials

1,789,665 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

340 Total Patients Enrolled

Olena Weaver, MDPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

1,000 Total Patients Enrolled

1 Trials studying Breast Cancer

1,000 Patients Enrolled for Breast Cancer

Media Library

Contrast Enhanced Digital Mammography Clinical Trial Eligibility Overview. Trial Name: NCT05056844 — N/A

Breast Cancer Research Study Groups: Diagnostic (CESM, DBT)

Breast Cancer Clinical Trial 2023: Contrast Enhanced Digital Mammography Highlights & Side Effects. Trial Name: NCT05056844 — N/A

Contrast Enhanced Digital Mammography 2023 Treatment Timeline for Medical Study. Trial Name: NCT05056844 — N/A

Frequently Asked Questions

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

Are researchers currently accepting volunteers for this research experiment?

"Affirmative. As per the clinicaltrials.gov listing, this research project is actively looking for participants and commenced on April 15th 2021. The latest update was recorded November 17 2022 with 66 patients needed from 1 medical centre."

Answered by AI

Does this clinical research project accept volunteers who are senior citizens?

"This trial's inclusion criteria specifies an age range of 25 to 85 years old for prospective participants."

Answered by AI

Could I be a suitable participant in this research project?

"This research project is seeking 66 individuals aged 25 to 85 who have galactorrhea. In order to be eligible, women must visit MDACC for the assessment of PND as a primary or accompanying symptom and agree to intravenous placement as well as iodinated contrast injection. Moreover, all participants need to provide informed consent prior to enrollment in this trial."

Answered by AI

What conditions can Digital Tomosynthesis Mammography typically be utilized to diagnose?

"Digital Tomosynthesis Mammography is an appropriate course of action for treating communicable diseases, implementing antisepsis measures, and curbing infection in minor abrasions."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Contrast Enhanced Spectral Mammography for the Evaluation of Pathologic Nipple Discharge

2021. "Contrast Enhanced Spectral Mammography for the Evaluation of Pathologic Nipple Discharge". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05056844.