Contrast-Enhanced Mammography for Breast Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: M.D. Anderson Cancer Center
Disqualifiers: Allergy to iodine, Anaphylaxis, Renal insufficiency, Pregnancy, others
No Placebo Group
Approved in 5 Jurisdictions
Trial Summary
What is the purpose of this trial?This clinical trial examines a new imaging technology, contrast-enhanced mammography, in predicting breast cancer. Contrast-enhanced mammography is similar to standard mammography, but it includes an intravenous (by vein) injection of iodine-based contrast, which makes tissue and blood vessels more visible in scans. Contrast-enhanced mammography may work better in detecting cancer in the breast that is not seen on other imaging tests and may help doctors find the most suspicious areas of the breast to biopsy, which could increase the chances of finding breast cancer.
Do I need to stop my current medications for the 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 Mammography (CEM) for breast cancer?
Research shows that Contrast-Enhanced Spectral Mammography (CESM), which is similar to CEM, is a reliable tool for detecting breast cancer and is considered diagnostically superior to traditional mammography. It combines digital imaging with the ability to highlight blood vessels in tumors, which can help in identifying cancer more effectively.
12345Is contrast-enhanced mammography safe for humans?
Contrast-enhanced mammography (CESM) has been studied in over 14,000 patients, and while it is generally considered safe, it can have some adverse reactions (unwanted effects). These reactions are typically related to the contrast dye used, similar to those in other imaging tests that use contrast.
14567How is contrast-enhanced mammography different from other breast cancer treatments?
Contrast-enhanced mammography (CEM) is unique because it combines traditional mammography with a special dye that highlights blood vessels, helping to detect tumors by showing areas of increased blood flow, which is often associated with cancer.
12489Eligibility Criteria
This trial is for women aged 25-85 who have suspicious breast abnormalities recommended for biopsy. Participants must be willing to undergo IV placement, iodinated contrast injection, and provide informed consent. They can't join if they've had allergic reactions to iodine contrast, recent breast surgery or biopsy at the site of interest, kidney issues, severe allergies to any substance, or are pregnant or breastfeeding within the last 6 months.Inclusion Criteria
I am between 25 and 85 years old.
Willing to participate in the study, undergo an IV placement, able to undergo iodinated contrast injection, and able to provide informed consent
I am a woman advised to have a stereotactic biopsy for suspicious breast changes, planning to undergo it at MDACC.
Exclusion Criteria
You have had a bad allergic reaction to iodine dye in the past.
Pregnancy or lactation within 6 months
History of anaphylactic reaction to any substance
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Diagnostic Imaging
Participants receive iodine-based contrast agent intravenously and undergo contrast-enhanced mammography (CEM) over 10-15 minutes
1 day
1 visit (in-person)
Follow-up
Participants are monitored for cancer detection rate and outcomes, including need for additional imaging, biopsies, and final pathologic results
Up to 3 years
Participant Groups
The study is testing a new imaging method called contrast-enhanced mammography which uses an iodine-based dye to improve visibility in scans. It aims to see if this technique is better at detecting cancers not found by other tests and helps pinpoint areas in the breast that need a biopsy.
1Treatment groups
Experimental Treatment
Group I: Diagnostic (iodine-based contrast, CEM)Experimental Treatment4 Interventions
Patients receive iodine-based contrast agent IV and the undergo CEM over 10-15 minutes.
Contrast-Enhanced Mammography is already approved in European Union, United States, China for the following indications:
🇪🇺 Approved in European Union as CEM for:
- Breast cancer detection
- Preoperative staging
- Neoadjuvant chemotherapy response assessment
🇺🇸 Approved in United States as CEM for:
- Breast cancer detection
- Supplemental screening in dense breasts
🇨🇳 Approved in China as CEM for:
- Breast cancer detection
- Preoperative staging
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
National Cancer Institute (NCI)Collaborator
References
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.
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 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.
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.
Technique, protocols and adverse reactions for contrast-enhanced spectral mammography (CESM): a systematic review. [2020]We reviewed technical parameters, acquisition protocols and adverse reactions (ARs) for contrast-enhanced spectral mammography (CESM). A systematic search in databases, including MEDLINE/EMBASE, was performed to extract publication year, country of origin, study design; patients; mammography unit/vendor, radiation dose, low-/high-energy tube voltage; contrast molecule, concentration and dose; injection modality, ARs and acquisition delay; order of views; examination time. Of 120 retrieved articles, 84 were included from 22 countries (September 2003-January 2019), totalling 14012 patients. Design was prospective in 44/84 studies (52%); in 70/84 articles (83%), a General Electric unit with factory-set kVp was used. Per-view average glandular dose, reported in 12/84 studies (14%), ranged 0.43-2.65 mGy. Contrast type/concentration was reported in 79/84 studies (94%), with Iohexol 350 mgI/mL mostly used (25/79, 32%), dose and flow rate in 72/84 (86%), with 1.5 mL/kg dose at 3 mL/s in 62/72 studies (86%). Injection was described in 69/84 articles (82%), automated in 59/69 (85%), manual in 10/69 (15%) and flush in 35/84 (42%), with 10-30 mL dose in 19/35 (54%). An examination time
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.
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.
Association between lesion enhancement and breast cancer in contrast-enhanced spectral mammography. [2022]Contrast-enhanced spectral mammography (CESM) may help to determine the malignancy potential of lesions according to the degree of enhancement.