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

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. ^{1 2 3 4 5}

Is 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. ^{1 3 5 6 7}

How 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. ^{1 4 7 8 9}

Research Team

Olena Weaver

Principal Investigator

M.D. Anderson Cancer Center

Eligibility 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.

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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) 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 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) 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]

References

1. Germany 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. [2020]

2. Ireland 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. [2018]

3. Ireland 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. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Contrast-enhanced spectral mammography (CESM). [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Contrast-enhanced Spectral Mammography: Modality-Specific Artifacts and Other Factors Which May Interfere with Image Quality. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Challenges in contrast-enhanced spectral mammography interpretation: artefacts lexicon. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Contrast-enhanced Spectral Mammography: Technique, Indications, and Clinical Applications. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Correlation between quantitative assessment of contrast enhancement in contrast-enhanced spectral mammography (CESM) and histopathology-preliminary results. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Diagnostic Value of Contrast-Enhanced Spectral Mammography for Screening Breast Cancer: Systematic Review and Meta-analysis. [2019]