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Contrast-Enhanced Mammography for Breast Cancer Screening (SCEMAM Trial)
SCEMAM Trial Summary
This trial is testing whether contrast-enhanced mammography (CEM) is as effective as screening breast MRI for women for whom MRI is not feasible.
SCEMAM Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SCEMAM Trial Design
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Who is running the clinical trial?
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- Women aged 40-75 with very dense breasts.You have noticeable breast changes like a lump, nipple discharge, or nipple retraction, or you have been getting checked for a breast abnormality.You have a high risk of breast cancer due to genetic mutations, past radiation therapy to the chest before the age of 30, or a strong family history of breast cancer.Your kidneys are not working well, with an eGFR less than 45 mL/min.Women under 75 years old who are advised to have yearly MRI and mammogram screenings based on current guidelines.You are currently receiving treatment for cancer with chemotherapy, but not with oral hormone therapy like aromatase inhibitors or tamoxifen.Women with dense breasts and family history of breast cancer who are not considered at high risk starting at age 40 or ten years before the youngest relative's age, but not before age 30.You have breast implants.You are younger than 30 or older than 75 years old.Women with lobular carcinoma in situ diagnosed within the past year.You had breast surgery in the last year.If you are a woman who had breast cancer before age 50 or have dense breasts after being diagnosed with breast cancer, you cannot participate.
- Group 1: Contrast-enhanced mammography
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Does the research allow for participants aged 30 or younger?
"Eligible participants of this research must be between 30 and 75 years old. For those under 18, there are 74 relevant trials while 2505 studies focus on elderly patients."
What is the capacity of this trial for enrolling participants?
"That is correct. According to information published on clinicaltrials.gov, this study started accepting participants on February 15th 2021 and was last modified on September 2nd 2022. 600 patients are needed across 3 different sites for the trial's completion."
Is it still possible to join this investigative research?
"Affirmative. According to the information provided on clinicaltrials.gov, this medical research is actively recruiting participants since its initial posting on February 15th 2021. The study seeks a total of 600 patients from 3 different sites and was most recently updated on September 2nd 2022."
Is Contrast-enhanced mammography a risk-free procedure for patients?
"As this Phase 4 trial indicates Contrast-enhanced mammography has already been approved, our team at Power assessed its safety with a score of 3."
Is it possible for me to partake in this clinical research study?
"This trial is looking to enrol 600 individuals aged between 30 and 75, who have a current diagnosis of breast cancer. Furthermore, applicants must also fit the following criteria: Women endowed with a pathogenic mutation putting them at elevated risk for developing this disease; prior chest radiation therapy received 8 years earlier as well as before age 30 or lifetime risks estimated at above 20%, females possessing extremely dense breasts in the 40-75 year range (7% of screened population), women diagnosed with lobular carcinoma in situ post one year from detection (0.06% of screening population), those who had personal histories of having their malignancy identified by age"
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