CESM for Breast Cancer Detection
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: M.D. Anderson Cancer Center
Disqualifiers: Allergy to iodine, Renal insufficiency, Pregnancy, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This clinical trial studies contrast enhanced spectral mammography (CESM) for the evaluation of pathologic nipple discharge. CESM is similar to standard mammography, but it includes an intravenous (by vein) injection of an iodine-based contrast, which makes tissue and blood vessels more visible in scans. The goal of this trial is to learn if CESM, is better than standard mammography in quickly and efficiently determining the cause of nipple discharge and detecting breast cancer, if present. CESM may increase the chance of finding breast cancers and lower the risk of having unnecessary biopsies.
Do I need to stop my current medications for the CESM trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Contrast Enhanced Spectral Mammography (CESM) for breast cancer detection?
Research shows that CESM is a valuable tool for diagnosing and staging breast cancer, especially in women with dense breast tissue. It improves diagnostic accuracy by using a special contrast agent, which helps to reduce false results and increase the reliability of mammogram readings.
12345Is CESM safe for humans?
CESM, which uses a special dye to improve mammogram images, is generally considered to have low risks and might offer clinical benefits, especially for women recalled from breast cancer screening.
13567How is the treatment CESM different from other breast cancer detection methods?
CESM (Contrast Enhanced Spectral Mammography) is unique because it combines a special contrast dye with traditional mammography to improve the detection of breast cancer, especially in women with dense breast tissue. This method enhances the visibility of tumors by highlighting areas of increased blood flow, which is often associated with cancer.
14789Eligibility Criteria
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.Inclusion Criteria
I am a woman seeking evaluation for nipple discharge as a primary or secondary symptom.
I am between 25 and 85 years old.
Willing to participate in the study and undergo an IV placement, able to undergo iodinated contrast injection, and able to provide informed consent
Exclusion Criteria
My kidneys do not work properly.
I had a breast MRI within the last 2 years before my current symptoms started.
I had a breast biopsy near the nipple within the last 2 months.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Diagnostic Imaging
Patients receive iodine-based contrast agent intravenously and undergo CESM over 10-15 minutes. Patients who have not undergone standard of care DBT within 3 months from the study, also undergo DBT.
1 day
1 visit (in-person)
Follow-up
Participants are monitored for outcomes such as the need for additional imaging, biopsies, and final pathologic results.
up to 1 year
Participant Groups
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.
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.
Contrast Enhanced Digital Mammography is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Contrast Enhanced Mammography for:
- Evaluation of pathologic nipple discharge
- Detection of breast cancer
- Assessment of extent of disease in newly diagnosed breast cancers
- Monitoring response to chemotherapy given prior to surgery
🇪🇺 Approved in European Union as Contrast Enhanced Mammography for:
- Supplemental screening for dense breasts
- Evaluation of indeterminate findings on other diagnostic breast imaging studies
- Detection of breast cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
References
Contrast-enhanced spectral mammography in recalls from the Dutch breast cancer screening program: validation of results in a large multireader, multicase study. [2020]Contrast-enhanced spectral mammography (CESM) is a promising problem-solving tool in women referred from a breast cancer screening program. We aimed to study the validity of preliminary results of CESM using a larger panel of radiologists with different levels of CESM experience.
Quantification of enhancement in contrast-enhanced spectral mammography using a custom-made quantifier tool (I-STRIP): A proof-of-concept study. [2018]Contrast-enhanced spectral mammography (CESM) is diagnostically superior to full-field digital mammography. An important improvement for CESM would be the ability to quantify enhancement. In this proof-of-concept study we present a method for quantifying CESM enhancement.
Contrast-enhanced spectral mammography as work-up tool in patients recalled from breast cancer screening has low risks and might hold clinical benefits. [2018]Contrast-enhanced spectral mammography (CESM) is a reliable problem solving tool in the work-up of women recalled from breast cancer screening. We evaluated additional findings caused by CESM alone and outweighed them against the disadvantages of this technique.
Contrast-enhanced spectral mammography (CESM). [2019]Contrast-enhanced spectral mammography (CESM) is a valuable tool in the diagnosis and staging of primary breast cancer. It combines an iodinated contrast agent with conventional mammography to improve diagnostic accuracy, particularly in women with denser parenchymal background patterns. This review describes the CESM technique, reviews performance compared to conventional mammography and magnetic resonance imaging, assesses its role in the diagnosis and staging of primary breast cancer, and investigates its potential as a screening tool.
Contrast-enhanced Spectral Mammography: Modality-Specific Artifacts and Other Factors Which May Interfere with Image Quality. [2018]Contrast-enhanced spectral mammography (CESM) uses full field digital mammography with the added benefit of intravenous contrast administration to significantly reduce false-positive and false-negative results and improve specificity while maintaining high sensitivity. For CESM to fulfill its purpose, one should be aware of possible artifacts and other factors which may interfere with image quality, and attention should be taken to minimize these factors.
Challenges in contrast-enhanced spectral mammography interpretation: artefacts lexicon. [2016]To review and describe commonly encountered artefacts in contrast-enhanced spectral mammography (CESM).
Contrast-enhanced Spectral Mammography: Technique, Indications, and Clinical Applications. [2022]Contrast-enhanced spectral mammography (CESM) combines the benefits of full field digital mammography with the concept of tumor angiogenesis. Technique and practical applications of CESM are discussed.
Correlation between quantitative assessment of contrast enhancement in contrast-enhanced spectral mammography (CESM) and histopathology-preliminary results. [2020]Contrast-enhanced spectral mammography (CESM) is a novel method for breast cancer detection. The aim of this study is to check if there is a possibility of quantitative assessment of contrast enhancement in CESM and if there is any correlation between quantitative assessment of contrast enhancement in CESM and histopathology.
Diagnostic Value of Contrast-Enhanced Spectral Mammography for Screening Breast Cancer: Systematic Review and Meta-analysis. [2019]Contrast-enhanced spectral mammography (CESM) is a new image examination technology that has developed over the past few years. As CESM technology keeps improving, a current meta-analysis review is needed to systematically evaluate the potential diagnostic value of CESM.