What side effects are associated with this type of intervention?

Common side effects of mammography, including those related to investigational breast cancer screening and diagnosis technologies, primarily involve discomfort or pain during the procedure due to breast compression. Additionally, there is a risk of false positives, which can lead to unnecessary anxiety and further invasive procedures such as biopsies. Radiation exposure, although minimal, is another concern, particularly with repeated screenings. False negatives are also possible, potentially delaying diagnosis and treatment.

What prior FDA approvals exist?

The FDA has approved several technologies and drugs for breast cancer screening and diagnosis, including digital mammography systems and 3D mammography (tomosynthesis), which improve detection rates and reduce false positives. Additionally, targeted therapies such as trastuzumab (Herceptin) for HER2-positive breast cancer have been approved, enhancing treatment efficacy. These advancements align with ongoing research into new mammography technologies aimed at improving early detection and diagnostic accuracy.

What other types of research exist?

Promising novel alternatives to investigational devices for breast cancer screening and diagnosis in 2024 include digital breast tomosynthesis, contrast-enhanced mammography, ultrasound with elastography or microbubbles, breast MRI, breast-specific gamma imaging, and breast CT scanning. These technologies offer enhanced detection capabilities and provide clinically relevant information that can aid in the diagnosis and treatment planning for breast cancer patients.

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Mammography Technology

New Mammography Technology for Breast Cancer Screening

N/A

Recruiting

Research Sponsored by Hologic, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Indicated for a screening or diagnostic mammogram or breast biopsy

At least 35 years old

Must not have

Wheelchair bound and cannot stand independently

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves standard mammography procedures with a new device, side effects might include discomfort during the procedure and exposure to low-dose radiation typical of standard mammograms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am due for a mammogram or breast biopsy.

Select...

I am at least 35 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I use a wheelchair and cannot stand on my own.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinically acceptable image quality of the Investigational Device.

Mammograms can be safety acquired on the Investigational Device.

Secondary study objectives

Subject assessment of comfort of the Investigational Device.

The ease of positioning and usability of the Investigational Device.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Investigational Mammogram ExamExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mammography

2015

N/A

~1450

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Mammograms are essential for early breast cancer detection, leading to treatments such as surgery, radiation therapy, chemotherapy, and endocrine therapy. Surgery removes the tumor, radiation uses high-energy rays to kill cancer cells, chemotherapy targets rapidly dividing cells, and endocrine therapy blocks hormones that fuel cancer growth. Advanced screening technologies, like the investigational device, enhance early detection, allowing for more effective and less invasive treatments, ultimately improving patient outcomes.