Contrast-Enhanced Mammography for Breast Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Allergy to iodine, Anaphylaxis, Renal insufficiency, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to improve breast cancer detection using contrast-enhanced mammography. This imaging test resembles a regular mammogram but uses a special dye to highlight breast tissue and blood vessels more clearly. The aim is to help doctors identify potentially cancerous areas and determine where to take a biopsy, increasing the chances of early cancer detection. Women advised to undergo a biopsy for suspicious breast changes and having the procedure at MD Anderson Cancer Center may be suitable for this trial. As an unphased study, this trial offers a unique opportunity to contribute to advancements in breast cancer detection technology.

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 prior data suggests that contrast-enhanced mammography is safe for breast cancer detection?

Research shows that contrast-enhanced mammography, which involves injecting a special iodine-based dye into a vein, is generally well-tolerated. This imaging method helps detect breast cancer earlier, especially in women with dense breast tissue, and it usually does not cause significant side effects. Most people handle it well, though some might feel a warm sensation or notice a slight rash from the iodine dye. These reactions are typically mild and resolve quickly. Studies have not reported any serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about contrast-enhanced mammography (CEM) because it combines traditional mammography with an iodine-based contrast agent to improve the visibility of breast cancer. Unlike standard mammograms, which can sometimes miss small or dense tumors, CEM enhances the contrast of images, potentially making it easier to detect abnormalities. This method could lead to more accurate diagnoses and earlier detection of breast cancer, which is crucial for effective treatment. The use of an iodine-based contrast agent is a key feature that sets CEM apart from current imaging options, providing a clearer picture of what’s happening inside the breast.

What evidence suggests that contrast-enhanced mammography is effective for detecting breast cancer?

Research has shown that contrast-enhanced mammography (CEM), which participants in this trial will undergo, is a useful tool for detecting breast cancer, particularly in women with dense breast tissue. Studies indicate that combining CEM with other imaging methods improves early detection of breast cancer. Specifically, one study found that CEM increased the detection of early-stage breast cancer by 13%. CEM also proves more effective than traditional ultrasound, identifying three times as many invasive cancers. This technology uses an iodine-based contrast to highlight tissues and blood vessels, making suspicious areas easier to see on scans. Overall, CEM excels at accurately identifying breast cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Olena Weaver

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Contrast-Enhanced Mammography

Trial Overview 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.

How Is the Trial Designed?

Group I: Diagnostic (iodine-based contrast, CEM) Experimental Treatment 4 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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 839 women recalled from breast cancer screening, contrast-enhanced spectral mammography (CESM) detected 70 lesions that were not identified by standard methods, with over half (54.3%) of these lesions being malignant, primarily invasive ductal carcinomas.

CESM demonstrated a low risk profile, with only five minor adverse reactions reported and a median radiation dose of 6.0 mGy per exam, suggesting it is a safe and effective tool for further evaluation in breast cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast-enhanced spectral mammography as work-up tool in patients recalled from breast cancer screening has low risks and might hold clinical benefits. Houben, IPL., Van de Voorde, P., Jeukens, CRLPN., et al.[2018]

A new tool called I-STRIP was developed to quantify enhancement in contrast-enhanced spectral mammography (CESM), showing that this method can accurately measure iodine mass thickness in breast tissue without affecting image quality or workflow during clinical use.

In a study involving five patients, CESM was able to significantly differentiate between malignant and benign breast lesions based on the contrast grey values, indicating its potential for improved diagnostic accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantification of enhancement in contrast-enhanced spectral mammography using a custom-made quantifier tool (I-STRIP): A proof-of-concept study. Lobbes, MBI., Mulder, HKP., Rousch, M., et al.[2018]

Contrast-enhanced spectral mammography (CESM) significantly improves the accuracy of breast cancer detection by reducing false-positive and false-negative results while maintaining high sensitivity.

The study highlights that many artifacts affecting image quality in CESM can be easily resolved, providing valuable insights for practitioners to enhance the effectiveness of this imaging technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast-enhanced Spectral Mammography: Modality-Specific Artifacts and Other Factors Which May Interfere with Image Quality. Bhimani, C., Li, L., Liao, L., et al.[2018]

Contrast-enhanced spectral mammography (CESM) shows high diagnostic accuracy for breast cancer, with a pooled sensitivity of 89% and specificity of 84% based on a meta-analysis of 18 studies.

The diagnostic odds ratio for CESM is 71.36, indicating it is a reliable tool for the initial assessment of breast lesions, making it a valuable option in breast cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic Value of Contrast-Enhanced Spectral Mammography for Screening Breast Cancer: Systematic Review and Meta-analysis. Zhu, X., Huang, JM., Zhang, K., et al.[2019]

In a study of 128 patients with BI-RADS 4 and 5 lesions, contrast-enhanced spectral mammography (CESM) showed a high sensitivity of 98.1% for detecting malignancy, indicating its effectiveness in identifying potentially cancerous lesions.

The degree of contrast enhancement in CESM, scored on a 4-point scale, can be a useful tool in clinical practice for predicting the malignancy potential of breast lesions, with an overall accuracy of 85.9%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between lesion enhancement and breast cancer in contrast-enhanced spectral mammography. Boy, FNS., Goksu, K., Tasdelen, I.[2022]

In a study of 167 female patients, contrast-enhanced spectral mammography (CESM) was able to quantitatively assess contrast enhancement, revealing a significant correlation between the degree of enhancement and the malignancy of breast lesions.

The analysis showed that infiltrating cancers exhibited the highest enhancement values, while benign lesions had the lowest, indicating that CESM can effectively differentiate between invasive cancers and benign or non-invasive lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation between quantitative assessment of contrast enhancement in contrast-enhanced spectral mammography (CESM) and histopathology-preliminary results. Rudnicki, W., Heinze, S., Niemiec, J., et al.[2020]

Contrast-enhanced spectral mammography (CESM) effectively combines digital mammography with tumor angiogenesis assessment, enhancing its utility in breast cancer detection.

CESM has been successfully integrated into clinical practice for various purposes, including screening, diagnosis, staging, and monitoring treatment response, highlighting its versatility in managing breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast-enhanced Spectral Mammography: Technique, Indications, and Clinical Applications. Bhimani, C., Matta, D., Roth, RG., et al.[2022]

Contrast-enhanced spectral mammography (CESM) significantly improves diagnostic accuracy in breast cancer detection, achieving a sensitivity of 96.9% and a specificity of 69.7% across a diverse group of radiologists.

The study confirms that CESM is superior to conventional mammography, providing excellent problem-solving capabilities for women referred from breast cancer screening programs, regardless of the radiologists' experience levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast-enhanced spectral mammography in recalls from the Dutch breast cancer screening program: validation of results in a large multireader, multicase study. Lalji, UC., Houben, IP., Prevos, R., et al.[2020]

A systematic review of 84 studies involving 14,012 patients found that contrast-enhanced spectral mammography (CESM) is generally safe, with a low adverse reaction rate of 0.82%, including only one severe non-fatal reaction.

The study highlighted the need for standardization in CESM protocols, as most studies used similar parameters, such as a contrast dose of 1.5 mL/kg at a flow rate of 3 mL/s and a 120-second acquisition delay, but only half of the studies were prospective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technique, protocols and adverse reactions for contrast-enhanced spectral mammography (CESM): a systematic review. Zanardo, M., Cozzi, A., Trimboli, RM., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8018270/

The effectiveness of contrast-enhanced spectral ... Our study showed that CESM is a great diagnostic tool not only for patients with fatty type breast but also for those with glandular type. Therefore, MRI and ...

2. pubs.rsna.org pubs.rsna.org/doi/10.1148/radiol.242634

Screening for Breast Cancer with Contrast-enhanced ... Adding contrast-enhanced mammography to digital breast tomosynthesis significantly increased early breast cancer detection alongside a 13% increase in the ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0720048X25004371

Contrast-Enhanced Mammography: Bridging the research ... Interim results have demonstrated that supplemental contrast imaging facilitate earlier cancer detection in women with dense breasts, without significant ...

4. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(25)00582-3/fulltext

Comparison of supplemental breast cancer imaging ... Abbreviated breast MRI and contrast-enhanced mammography detected three times as many invasive cancers than whole breast ultrasound. The ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/14/9/e069788

Meta-analysis and systematic review of the diagnostic ... Conclusions The CESM has high sensitivity and good specificity when it comes to evaluating breast cancer, particularly in women with dense breasts. Thus, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10680079/

Contrast-Enhanced Mammography in Breast Cancer Screening The overall cancer detection rate was 15.5 per 1000 women, which is similar to MRI. Follow-up data for these patients are currently pending. Among a small ...

7. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.2021201948

Contrast-enhanced Mammography: State of the Art Contrast-enhanced breast MRI is recommended for women at high risk of developing breast cancer (ie, >20% lifetime risk of developing breast ...

8. ascopubs.org ascopubs.org/doi/10.1200/jco.2015.33.15_suppl.11069

Contrast-enhanced spectral mammography (CESM) ... Results: Both CESM and BMRI are shown to have sensitivity of 98% for breast cancer detection. No statistical significance was identified on the ...

9. ajronline.org ajronline.org/doi/10.2214/AJR.22.28567

Barriers to Implementation of Contrast-Enhanced ... Studies also indicate that the use of CEM may reduce the number of benign biopsies performed of lesions detected on routine mammography, digital breast ...