CESM for Breast Cancer Detection

Overseen By Olena Weaver

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

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

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if contrast-enhanced spectral mammography (CESM) is more effective than regular mammograms in identifying the cause of unusual nipple discharge and detecting breast cancer. CESM uses a dye injected into the vein to enhance image clarity, potentially improving breast cancer detection and reducing unnecessary biopsies. Women who have noticed nipple discharge and can tolerate a dye injection might be suitable candidates for this trial. As an unphased trial, this study provides an opportunity to contribute to important research that could enhance breast cancer detection methods.

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

Previous studies have shown that contrast-enhanced mammography (CEM) is very effective in detecting breast cancer. This technique uses a special dye to make tissues clearer during scans. Research indicates that modern dyes are generally safe, though some people might experience mild to severe allergic reactions. Although rare, these reactions are considered when assessing safety.

Overall, contrast-enhanced mammography is a promising method for improving breast cancer diagnosis, with a safety record suggesting most patients handle it well. Prospective participants should discuss any concerns with a healthcare provider before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Contrast Enhanced Digital Mammography (CESM) for breast cancer detection because it offers a unique approach compared to traditional methods like standard mammograms and Digital Breast Tomosynthesis (DBT). CESM involves using an iodine-based contrast agent, which highlights blood vessels in the breast to improve the visibility of tumors. This method can provide more detailed images, potentially leading to earlier and more accurate detection of breast cancer. By combining CESM with DBT, this technique may improve diagnostic accuracy, helping doctors make better-informed decisions regarding patient care.

What evidence suggests that CESM is effective for breast cancer detection?

Research has shown that contrast-enhanced spectral mammography (CESM), which participants in this trial will undergo, effectively detects breast cancer, particularly in women with dense breast tissue. One study found that CESM detected breast cancer 98% of the time. Another study demonstrated that CESM was more accurate in diagnosing breast cancer than standard digital mammography. Additionally, CESM increased the cancer detection rate by 13.1 per 1,000 women, even identifying invasive cancers that other methods missed. These findings suggest that CESM could be a powerful tool for diagnosing breast cancer more accurately and reducing unnecessary biopsies. ^{2 3 6 7 8}

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 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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Contrast Enhanced Digital Mammography
• Iodinated Contrast Agent

Trial Overview 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.

How Is the Trial Designed?

Group I: Diagnostic (CESM, DBT) Experimental Treatment 4 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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

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) 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]

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]

In a study of 200 women undergoing contrast-enhanced spectral mammography (CESM), two common artefacts, rim and ripple artefacts, were identified, with the rim artefact appearing in 97-99% of projections and the ripple artefact being more prevalent in oblique projections (80-82%).

Importantly, these artefacts do not interfere with the interpretation of CESM images, highlighting the need for radiologists to recognize them to avoid misdiagnosing them as actual breast pathology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges in contrast-enhanced spectral mammography interpretation: artefacts lexicon. Yagil, Y., Shalmon, A., Rundstein, A., et al.[2016]

Contrast-enhanced spectral mammography (CESM) improves diagnostic accuracy for primary breast cancer, especially in women with dense breast tissue, by combining iodinated contrast agents with traditional mammography.

CESM shows promising performance compared to conventional mammography and magnetic resonance imaging, indicating its potential role not only in diagnosis and staging but also as a screening tool for breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast-enhanced spectral mammography (CESM). James, JJ., Tennant, SL.[2019]

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 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]

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. 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 ...

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

Contrast-enhanced Mammography: State of the Art CEM has been demonstrated to help improve accuracy compared with digital mammography and US in women with abnormal screening mammographic ...

4. ajronline.org ajronline.org/doi/abs/10.2214/AJR.17.19355

Contrast-Enhanced Spectral Mammography in Women With ... The incremental cancer detection rate of CESM was 13.1/1000 women (95% CI, 6.1–20.1). Of eight cancers seen only with CESM, seven were invasive (mean size, 9 mm ...

5. 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 ...

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

Contrast-Enhanced Mammography in Breast Cancer Screening Contrast-enhanced mammography (CEM) is a promising vascular-based breast imaging technique with high diagnostic performance in detecting breast cancer.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05625659

Comparison of Breast Cancer Screening With CESM to ... Aim 2: To evaluate the performance of CESM compared to DBT at the 1-year follow up for breast-cancer screening in women with dense breasts. Detailed Description.

8. ajronline.org ajronline.org/doi/10.2214/AJR.19.22412

Contrast-Enhanced Digital Mammography: Technique ... Contrast-enhanced digital mammography (CEDM) combines the high spatial resolution of mammography with the improved enhancement provided by contrast medium.