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

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{1 4 5 6 7}

How 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. ^{1 2 4 8 9}

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.

Research Team

Olena Weaver

Principal Investigator

M.D. Anderson Cancer Center

Eligibility 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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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]

References

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

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

2. Germany pubmed.ncbi.nlm.nih.gov

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

3. 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]

4. 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]

5. 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]

6. Germany pubmed.ncbi.nlm.nih.gov

Technique, protocols and adverse reactions for contrast-enhanced spectral mammography (CESM): a systematic review. [2020]

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

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

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

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

9. England pubmed.ncbi.nlm.nih.gov

Association between lesion enhancement and breast cancer in contrast-enhanced spectral mammography. [2022]