New Mammography Technology for Breast Cancer Screening

Recruiting at 13 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mammography device, the IzoView Breast CT Imaging System, to determine its safety and effectiveness for breast cancer screening and diagnosis. The goal is to enhance breast cancer detection, aiding doctors in early identification and treatment. Women aged 35 and older who require a mammogram or breast biopsy may qualify for this study. Participants should not have breast implants or any metal devices in the chest area. As an unphased trial, this study allows participants to contribute to advancements in breast cancer detection technology.

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 prior data suggests that this investigational device is safe for breast cancer screening?

Research shows that the new mammogram technology under testing has not yet been studied in clinical trials. Without trial data, solid proof of its safety cannot be provided. However, the current phase of development focuses on gathering information about its safety and effectiveness, a standard step to ensure safe use in people.

This type of device typically aims to enhance image quality and improve safety. The goal is to provide a more accurate and comfortable imaging experience for patients. Testing of this new device is crucial to confirm its safety and effectiveness before approval for regular use in screenings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this new mammography technology for breast cancer screening because it promises greater accuracy and earlier detection compared to traditional mammograms. Unlike standard mammograms, which can sometimes miss small tumors or produce false positives, this investigational device may provide clearer and more detailed images of breast tissue. The hope is that this advanced imaging technique will improve the identification of potential issues earlier, leading to more timely and effective interventions.

What evidence suggests that this investigational device is effective for breast cancer screening?

Research has shown that current mammograms miss about 10-12% of breast cancers during screenings. This trial tests a new device, the IzoView Breast CT Imaging System, which aims to improve detection by providing true 3D images of the breast. This technology could identify cancers that regular mammograms might miss. The device also eliminates the need for breast compression, potentially making the process more comfortable. Although clinical trials have not yet fully tested this technology, its 3D imaging capability appears promising. It could detect breast cancer earlier and more accurately. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. izocorp.com izocorp.com/izoview/breast-ct-clinical-data/

Izotropic Corporation | Breast CT Clinical Data IzoView remains an investigational device and has not been evaluated in clinical trials or studies to support claims of diagnostic performance. No assurances ...

2. izocorp.com izocorp.com/news-releases/izotropics-izoview-breast-ct-device-stands-distinct-vs-existing-breast-imaging-technologies/

Breast CT Innovation | IzoView Stands Apart Discover how IzoView sets a new standard in Breast CT—offering low-cost, true 3D breast imaging without compression that could outpace ...

3. finance.yahoo.com finance.yahoo.com/news/izotropic-marks-breast-cancer-awareness-120000623.html

Izotropic Marks Breast Cancer Awareness Month by ... Studies indicate that approximately 20% of breast cancers present at the time of screening mammography are missed, 10–12% of screenings return ...

4. biospace.com biospace.com/press-releases/izotropic-files-pre-submission-with-u-s-fda-for-breast-cancer-screening

Izotropic Files Pre-Submission with U.S. FDA for Breast ... Conversely, current breast imaging modalities return false negative results on 10-12% of breast cancer screenings, and 50-60% of women can ...

5. health.ucdavis.edu health.ucdavis.edu/news/headlines/breast-ct-scanner-invented-at-uc-davis-is-closer-to-commercialization-/2024/04

Breast CT scanner invented at UC Davis is closer to ... A new breast cancer screening option using computed tomography (CT) invented at UC Davis may be cleared for FDA clinical trials.

6. izocorp.com izocorp.com/site/assets/files/6003/izotropic_izoview_technology_presentation_breast_ct.pdf

IzoView – Dedicated Breast CT Imaging Technology by ... IzoView, the commercial breast CT system developed by Izotropic Corporation, is a distinct and separate device designed for commercial use and ...

7. biospace.com biospace.com/press-releases/izotropics-ai-breakthrough-positions-izoview-to-redefine-breast-ct-imaging-standards

Izotropic's AI Breakthrough Positions IzoView to Redefine ... Proprietary algorithm positions IzoView to redefine global standards and expectations for image quality and safety in breast CT -.

8. breastct.com breastct.com/

Breast CT by Izotropic Corporation | MedTech Investment ... It's another way IzoView is engineered to prioritize both safety and precision, to deliver a smarter, more patient-specific imaging experience. AI-Powered Image ...

9. finance.yahoo.com finance.yahoo.com/news/izotropic-ai-breakthrough-positions-izoview-120000813.html

Izotropic's AI Breakthrough Positions IzoView to Redefine ... Proprietary algorithm positions IzoView to redefine global standards and expectations for image quality and safety in breast CT -.