New Mammography Technology for Breast Cancer Screening

Recruiting at 3 trial locations

Overseen By Geena Thomas

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Hologic, Inc.

Disqualifiers: Pregnancy, Breast implants, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 years

7500 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new device designed to help screen for and diagnose breast cancer. It targets individuals who are undergoing breast cancer screening and diagnosis. The device works by scanning breast tissue to identify any unusual changes or lumps that could indicate cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the IzoView Breast CT Imaging System treatment for breast cancer screening?

Research on breast CT systems shows promising results, with excellent anatomical detail and good visualization of tumors, similar to the IzoView system. Initial studies indicate that breast CT can effectively enhance tumor visualization, especially with iodine contrast, suggesting it may play a role in breast cancer imaging. ^{1 2 3 4 5}

Is the IzoView Breast CT Imaging System safe for humans?

The breast CT system, including the IzoView, has been tested on 55 women, including healthy volunteers and those with a high likelihood of breast cancer, using radiation doses similar to standard mammography. Initial results show promising imaging quality, and the system is undergoing further safety and performance evaluations. ^{1 3 5 6 7}

How is the IzoView Breast CT Imaging System different from other breast cancer screening treatments?

The IzoView Breast CT Imaging System is unique because it uses a dedicated computed tomography (CT) system to scan the breast in a pendant position, providing detailed 3D images without compressing the breast, unlike traditional mammography. This method offers excellent anatomical detail and visualization of soft tissue and microcalcifications, potentially improving the detection of breast cancer, especially in dense breast tissue. ^{1 3 6 8 9}

Eligibility Criteria

This trial is for women at least 35 years old who need a mammogram or breast biopsy, regardless of race and ethnicity. It's not for those who may be pregnant, cannot stand independently due to being wheelchair-bound, have breast implants, pacemakers, or IV ports in the area where the mammogram takes pictures, or have been in this study before.

Inclusion Criteria

I am due for a mammogram or breast biopsy.

I am at least 35 years old.

I am a woman.

Exclusion Criteria

Has breast implants, cardiac pacemakers, or IV ports in the mammography field of view

I use a wheelchair and cannot stand on my own.

Previously participated in the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo investigational mammogram exams to evaluate the safety and efficacy of the device

4 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Investigational Device

Trial Overview The study is testing new mammography technology aimed at improving breast cancer screening and diagnosis. The goal is to determine how safe and effective this new device is compared to current methods.

Participant Groups

Group I: Investigational Mammogram Exam Experimental Treatment 1 Intervention

All subjects that are indicated for a screening or diagnostic mammogram or breast biopsy.

Who Is Running the Clinical Trial?

Hologic, Inc.

Lead Sponsor

Trials

48

Recruited

59,900+

Findings from Research

Breast CT imaging, utilizing advanced cone beam technology, is being developed as a promising alternative to traditional mammography, particularly due to its ability to reduce imaging artifacts and improve image quality.

A new prototype system for breast CT is being designed for image-guided interventional procedures, with plans for a multi-institutional clinical trial to evaluate its effectiveness in breast imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An X-Ray computed tomography/positron emission tomography system designed specifically for breast imaging. Boone, JM., Yang, K., Burkett, GW., et al.[2022]

Digital breast tomosynthesis is being increasingly adopted in breast imaging clinics due to its potential to overcome limitations of traditional mammography, as supported by early clinical data.

The article provides insights into how to interpret digital breast tomosynthesis images and discusses considerations for its integration into routine clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical implementation of digital breast tomosynthesis. Conant, EF.[2021]

A dedicated breast CT system has been developed and tested on 55 women, showing excellent anatomical detail and visualization of tumors, especially when using iodine contrast, which enhances tumor detection.

The breast CT system is designed to use radiation doses comparable to standard two-view mammography, making it a potentially safe alternative for breast cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computed tomography for imaging the breast. Boone, JM., Kwan, AL., Yang, K., et al.[2019]

New mammography technologies, particularly breast tomosynthesis, have been shown to increase breast cancer detection rates while reducing the number of unnecessary biopsies, making it a promising advancement in breast cancer screening.

Breast tomosynthesis is currently the only 3D mammography technique in clinical practice, and its FDA-approved protocol involves more imaging projections, which increases the associated risks of radiation exposure compared to traditional 2D mammography.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New mammography technologies and their impact on radiation dose]. Chevalier del Rio, M.[2016]

Screening mammography has significantly reduced breast cancer mortality by 41% since 1990 in the U.S., supported by various studies and advancements in therapy.

Digital breast tomosynthesis enhances the accuracy of mammography by improving sensitivity and specificity, making it particularly beneficial for patients with overlapping breast tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer screening in average and high-risk women. Rahman, WT., Helvie, MA.[2022]

Emerging breast imaging modalities, such as digital breast tomosynthesis (DBT) and molecular breast imaging, show promise in addressing the limitations of traditional mammography for various purposes including screening and diagnosis.

These new techniques may enhance the accuracy of breast cancer detection and treatment planning, potentially improving outcomes for patients, especially those at high risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging breast imaging modalities. Rush, B.[2012]

The newly designed dedicated breast scanner automates the scanning process, producing high-resolution images of the entire breast, which enhances the efficiency of image review.

Clinical evaluations of the scanner prototype demonstrated its effectiveness in assessing both normal breast tissue and various breast lesions, including benign and malignant cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound of the whole breast utilizing a dedicated automated breast scanner. Maturo, VG., Zusmer, NR., Gilson, AJ., et al.[2022]

Breast CT (BCT) technology has been developed to improve breast cancer screening by addressing limitations of traditional mammography, particularly in dense breast tissue, while maintaining radiation exposure similar to that of standard mammography.

The paper reviews over a decade of research and development in BCT, highlighting its potential advantages in early cancer detection and the ongoing efforts toward commercialization of this advanced imaging technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dedicated breast computed tomography: Basic aspects. Sarno, A., Mettivier, G., Russo, P.[2017]

Breast tomosynthesis, a 3D x-ray imaging technology for breast cancer screening, has been clinically used in the U.S. since 2011, indicating its established presence in medical practice.

The review highlights existing gaps in knowledge regarding the effectiveness and implications of breast tomosynthesis in cancer screening, suggesting that further research is needed to fully understand its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tomosynthesis for breast cancer screening. Cole, EB., Pisano, ED.[2018]

References

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

An X-Ray computed tomography/positron emission tomography system designed specifically for breast imaging. [2022]

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

Clinical implementation of digital breast tomosynthesis. [2021]

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

Computed tomography for imaging the breast. [2019]

4. Spain pubmed.ncbi.nlm.nih.gov

[New mammography technologies and their impact on radiation dose]. [2016]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Breast cancer screening in average and high-risk women. [2022]

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

Emerging breast imaging modalities. [2012]

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

Ultrasound of the whole breast utilizing a dedicated automated breast scanner. [2022]

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

Dedicated breast computed tomography: Basic aspects. [2017]

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

Tomosynthesis for breast cancer screening. [2018]