New Imaging Device for Mammograms

Overseen By Santina Wendling Clinical Project Manager

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Hologic, Inc.

Must not be taking: Chemotherapy

Disqualifiers: Breast implants, Pregnant, Breastfeeding, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

75 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are actively being treated for cancer with chemotherapy, you cannot participate in the trial.

How is the CEM Exam treatment different from other breast cancer imaging treatments?

The CEM Exam (Contrast-Enhanced Mammography) is unique because it combines regular mammogram images with contrast-enhanced images using an iodine-based contrast agent, providing detailed information about breast tissue. It offers similar sensitivity and specificity to MRI but is more cost-effective, quicker, and generally more acceptable to patients. ^{1 2 3 4 5}

What is the purpose of this trial?

This is a prospective, single-center image case collection study to acquire de-identified contrast-enhanced breast images on the Investigational Device to support continuing technology development. Eligible subjects include women at least 35 years old with a suspicious finding or breast abnormality on a screening or diagnostic mammogram who are indicated for a diagnostic exam or a biopsy procedure.

Research Team

Chirag Parghi, MD

Principal Investigator

Solis Mammography

Eligibility Criteria

This clinical trial is for women aged 35 or older who have had a suspicious finding or breast abnormality detected on a regular mammogram and are now indicated for further diagnostic exams or biopsy procedures.

Inclusion Criteria

I am a woman.

I am at least 35 years old.

Subject is able to read, understand, and sign the study-specific informed consent form (ICF) after the nature of the study has been fully explained to them

Exclusion Criteria

Subject is breastfeeding

Subject is pregnant or presumed to be pregnant

Subject is unable or unwilling to undergo informed consent or subject who requires a Legally Authorized Representative (LAR) for Informed Consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

CEM Investigational Exam

Participants undergo a contrast-enhanced mammography exam using the Investigational Device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the CEM exam

4 weeks

Treatment Details

Interventions

• CEM Exam

Trial Overview The study is testing the use of an investigational device to perform contrast-enhanced mammography (CEM) exams. The goal is to collect de-identified images to support the development of this new technology.

Participant Groups

Group I: CEM Investigational Exam Experimental Treatment 1 Intervention

All subjects enrolled in this study will undergo a CEM exam using Investigational Device

CEM Exam is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Contrast-Enhanced Mammography for:

• Breast cancer screening
• Diagnostic evaluation of breast abnormalities
• Preoperative assessment of breast cancer
• Follow-up of scars after conservative treatment

Approved in European Union as Contrast-Enhanced Mammography for:

• Breast cancer screening
• Diagnostic evaluation of breast abnormalities
• Preoperative assessment of breast cancer
• Follow-up of scars after conservative treatment

Approved in Canada as Contrast-Enhanced Mammography for:

• Breast cancer screening
• Diagnostic evaluation of breast abnormalities
• Preoperative assessment of breast cancer
• Follow-up of scars after conservative treatment

Who Is Running the Clinical Trial?

Hologic, Inc.

Lead Sponsor

Trials

48

Recruited

59,900+

Findings from Research

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]

Dual-energy contrast-enhanced mammography (CESM) is a promising new imaging technique for breast cancer that aims to overcome the limitations of traditional methods like MRI and CT, which can be expensive and expose patients to high radiation doses.

The review highlights both the advantages of CESM, such as improved imaging capabilities, and its drawbacks, indicating a need for further research to optimize its use in breast care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual-energy contrast-enhanced spectral mammography (CESM). Daniaux, M., De Zordo, T., Santner, W., et al.[2018]

Contrast-enhanced mammography (CEM) is a new breast imaging technology that combines contrast-enhanced images with standard low-energy images, potentially improving the detection of abnormalities in breast tissue.

CEM shows promise for supplemental screening, particularly in women with dense breast tissue, as it may enhance diagnostic performance while considering safety and cost factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast-Enhanced Mammography Implementation, Performance, and Use for Supplemental Breast Cancer Screening. Covington, MF.[2020]

Contrast-enhanced mammography (CEM) is an FDA-approved method for breast cancer detection that offers similar sensitivity and specificity to MRI, making it a reliable alternative.

CEM has advantages over MRI, including lower cost, better patient acceptability, and shorter examination times, although MRI is superior for imaging the complete axilla and chest wall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Contrast-Enhanced Mammography and Contrast-Enhanced Breast MR Imaging. Lewin, J.[2018]

Contrast-enhanced dual-energy mammography (CEDM) is a new breast imaging technique that uses an iodine-based contrast agent to improve cancer detection, showing promise in outperforming conventional mammography.

Preliminary studies suggest that CEDM may provide diagnostic performance comparable to breast MRI, indicating its potential as a valuable tool in breast cancer screening and diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast-enhanced dual-energy mammography: a promising new imaging tool in breast cancer detection. Lalji, U., Lobbes, M.[2016]

References

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

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

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

Dual-energy contrast-enhanced spectral mammography (CESM). [2018]

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

Contrast-Enhanced Mammography Implementation, Performance, and Use for Supplemental Breast Cancer Screening. [2020]

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

Comparison of Contrast-Enhanced Mammography and Contrast-Enhanced Breast MR Imaging. [2018]

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

Contrast-enhanced dual-energy mammography: a promising new imaging tool in breast cancer detection. [2016]