New Imaging Device for Mammograms

Recruiting at 1 trial location

Overseen By Alexis Cooper Senior Manager, Clinical Development-Clinical Affairs

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging device for mammograms to enhance breast imaging technology. The goal is to collect and study high-quality breast images from women with suspicious findings or abnormalities on their mammograms. Women aged 35 and older who require further tests, such as a diagnostic exam or biopsy, might be suitable for this trial. Participants will undergo a special type of mammogram called a CEM exam, which uses a contrast agent to highlight breast tissue. As an unphased trial, this study offers participants the chance to contribute to advancements in breast imaging technology.

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.

What prior data suggests that this imaging device is safe for mammograms?

Research has shown that contrast-enhanced mammography (CEM) is generally safe. Studies indicate that side effects from the contrast dye used in CEM are rare, occurring in only about 0.007% of patients. This means that out of 100,000 people undergoing CEM, only about 7 might experience a side effect.

The radiation from a CEM is about twice that of a regular mammogram. Despite this increase, the radiation level remains safe and is comparable to other common imaging tests. While there is a small risk of side effects from the contrast dye, CEM is a promising method for breast imaging and is generally well-tolerated by most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CEM Exam, a new imaging device for mammograms, because it offers a unique approach to breast cancer screening. Unlike traditional mammography which uses standard X-rays, the CEM Exam combines contrast-enhanced imaging with mammography, potentially improving the visibility of tumors. This could lead to earlier and more accurate detection of breast cancer, which is crucial for effective treatment. Additionally, this method might reduce unnecessary biopsies by providing clearer images, thus improving the overall patient experience.

What evidence suggests that this imaging device is effective for mammograms?

Studies have shown that contrast-enhanced mammography (CEM) effectively detects breast cancer. It highlights blood vessels in the breast, aiding doctors in identifying unusual areas. Research indicates that CEM can detect cancer earlier, particularly in women with dense breast tissue. Specifically, combining CEM with regular mammograms has increased early cancer detection by 13%. This early detection is crucial for starting treatment sooner and improving health outcomes. In this trial, all participants will undergo a CEM exam using an investigational device to further evaluate its effectiveness. ^{2 6 7 8 9}

Who Is on the Research Team?

Chirag Parghi, MD

Principal Investigator

Solis Mammography

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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 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]

Citations

1. 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.

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/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 ...

4. sbi-online.org sbi-online.org/white-papers/contrast-enhanced-digital-mammography

Contrast Enhanced Digital Mammography Screening mammography has been shown to reduce breast cancer mortality in randomized clinical trials. It has been an effective screening test for the past 4 ...

5. 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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8611680/

Contrast-enhanced mammography: what the radiologist ... Contrast-enhanced mammography (CEM) is a combination of standard mammography and iodinated contrast material administration.

7. densebreast-info.org densebreast-info.org/screening-technologies/contrast-enhanced-mammography/

Contrast-Enhanced Mammography (CEM) | DenseBreast ... The radiation dose from CEM is about twice that of a standard mammogram, but still within the accepted safe range. The dose is similar to a ...

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

Contrast-enhanced Mammography: State of the Art Although CEM is a promising tool, it slightly increases radiation dose and carries a small risk of adverse reactions to contrast materials. This ...

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

Barriers to Implementation of Contrast-Enhanced ... For example, early studies found radiation exposure to be higher for CEM than for DM or DBT alone, by 0.9 and 0.5 mGy, respectively, although lower than for the ...