← Back to Search

Diagnostic Test

CESM vs DBT Screening for Dense Breasts in Breast Cancer Detection (CMIST Trial)

N/A
Recruiting
Research Sponsored by American College of Radiology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women must not have symptoms or signs of benign or malignant breast disease (e.g., bloody, or clear nipple discharge, breast lump, focal breast pain)
Women must be able to undergo intravenous (IV) administration of iodinated contrast (e.g., no contraindication to intravenous contrast administration for Omnipaque [iohexol], and no known allergy-like reaction to iodine or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology [ACR])
Must not have
Women currently undergoing treatment for breast cancer, or planning surgery for a high-risk lesion (ADH, ALH, LCIS, papilloma, radial scar)
Women who are pregnant, breast feeding, or planning to become pregnant from screening until 30 days after the last administration of Omnipaque (iohexol)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare imaging techniques to detect breast cancer in women with dense breasts, to help reduce false positives.

Who is the study for?
This trial is for women with dense breasts who can have an IV contrast (no allergies to iodine or severe reactions to allergens), are not pregnant or breastfeeding, and do not have symptoms of breast disease. They must agree to avoid certain breast screenings and use effective contraception during the trial.
What is being tested?
The CMIST study is testing if CESM detects more cancers with fewer false positives than DBT in women with dense breasts. It compares the two methods at initial screening and again after one year.
What are the potential side effects?
CESM involves using IV contrast which may cause allergic reactions, kidney issues in those with pre-existing conditions, discomfort at injection site, nausea, or a warm feeling during the injection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I do not have any breast symptoms like lumps or unusual discharge.
Select...
I can safely receive IV contrast for scans without allergic reactions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently being treated for breast cancer or planning surgery for a high-risk breast lesion.
Select...
I am not pregnant, breastfeeding, nor planning to become pregnant soon.
Select...
I am a woman with a history of sickle cell disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cancer Detection Rate
Recall Rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: DBT and CESM Diagnostic Imaging in Women with Dense BreastsExperimental Treatment1 Intervention
Interventional Diagnostic

Find a Location

Who is running the clinical trial?

American College of RadiologyLead Sponsor
22 Previous Clinical Trials
8,052,236 Total Patients Enrolled
2 Trials studying Breast Cancer
175 Patients Enrolled for Breast Cancer
Breast Cancer Research FoundationOTHER
72 Previous Clinical Trials
135,871 Total Patients Enrolled
41 Trials studying Breast Cancer
128,477 Patients Enrolled for Breast Cancer
GE HealthcareIndustry Sponsor
297 Previous Clinical Trials
631,614 Total Patients Enrolled
32 Trials studying Breast Cancer
16,705 Patients Enrolled for Breast Cancer

Media Library

Dual-Energy Contrast-Enhanced Spectral Mammography (CESM) (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT05625659 — N/A
Breast Cancer Research Study Groups: DBT and CESM Diagnostic Imaging in Women with Dense Breasts
Breast Cancer Clinical Trial 2023: Dual-Energy Contrast-Enhanced Spectral Mammography (CESM) Highlights & Side Effects. Trial Name: NCT05625659 — N/A
Dual-Energy Contrast-Enhanced Spectral Mammography (CESM) (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05625659 — N/A
~97 spots leftby Jan 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top