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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])
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
CMIST Trial 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.Check my eligibility
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.See study design
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.
CMIST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have any breast symptoms like lumps or unusual discharge.
Select...
I can safely receive IV contrast for scans without allergic reactions.
CMIST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cancer Detection Rate
Recall Rate
CMIST 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
8,052,214 Total Patients Enrolled
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175 Patients Enrolled for Breast Cancer
Breast Cancer Research FoundationOTHER
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GE HealthcareIndustry Sponsor
291 Previous Clinical Trials
629,064 Total Patients Enrolled
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16,705 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a mammogram less than 11 months ago.I am not pregnant, breastfeeding, nor planning to become pregnant soon.I do not have any breast symptoms like lumps or unusual discharge.I am currently being treated for breast cancer or planning surgery for a high-risk breast lesion.I am a woman with potential kidney issues and may need a special test before certain dye tests.I am not pregnant or breastfeeding and have confirmed this with a test if necessary.I had a breast ultrasound less than 11 months ago.I had a breast imaging test within the last 3 years.I can safely receive IV contrast for scans without allergic reactions.I am a woman with a history of sickle cell disease.Women at high risk for breast cancer, unless they cannot have an MRI.I had a breast MRI within the last 3 years.I am using or will use effective birth control or abstain from sex for a year.I had a special breast scan within the last 3 years.Women who have silicone or saline breast implants.Women with large breasts that need more than one picture of each part of the breast during a mammogram.Women must have dense breasts based on their most recent mammogram.
Research Study Groups:
This trial has the following groups:- Group 1: DBT and CESM Diagnostic Imaging in Women with Dense Breasts
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the trial open to participants under the age of 20?
"This clinical trial is open to applicants aged 45-74 years old. Those under 18 and over 65 are encouraged to seek out the 68 and 2591 trials, respectively, that cater specifically to their age ranges."
Answered by AI
Who meets the criteria for participating in this trial?
"For admittance into this study, individuals must have been diagnosed with breast cancer and be between the ages of 45 to 74. In total, 2032 participants are being enrolled in the trial."
Answered by AI
How long is this medical experiment slated to continue?
"This trial is designed to last 2 Years, with a preliminary screening period of ~3 weeks and additional reporting requirements after the completion of treatment. The full duration will consist of three distinct phases: initial assessment, intervention implementation, and post-intervention data collection."
Answered by AI
Are there any available slots for participants to join this trial?
"According to clinicaltrials.gov, the recruitment phase of this study is ongoing since its initial posting on March 24th 2023 and last edit on May 24th 2023."
Answered by AI
What is the aggregate patient count of this clinical experiment?
"Yes, the evidence on clinicaltrials.gov suggests that this medical study is actively recruiting. It was initially posted to the website on March 24th 2023 and has been since updated as recently as May 24th 2023. The trial seeks a total of 2,032 patients at one specific site."
Answered by AI
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