Spot Compression Ultrasound for Breast Lump Detection

EL
Overseen ByEun L Langman, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of using ultrasound to detect breast lumps. Unlike standard ultrasound, this approach employs "ultrasound in the grid" during a mammogram to determine if it can identify lumps more accurately and quickly. The study will compare the results of this new method with usual care to evaluate which is more effective. It is suitable for individuals with a breast lump visible on both a mammogram and an ultrasound, and smaller than 3 cm. As an unphased trial, this study allows patients to contribute to innovative research that could enhance breast lump detection methods.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems unlikely that you would need to stop, as the study focuses on imaging techniques rather than medication effects.

What prior data suggests that this ultrasound technique is safe for breast lump detection?

Research has shown that ultrasound is a safe and well-tolerated method for detecting breast cancer. One important study found that ultrasound correctly identified breast cancer 89.25% of the time and rarely gave false alarms, with a 99.1% accuracy rate. This makes it a reliable tool, especially for women with dense breast tissue.

Ultrasound is also safer because it doesn't use radiation, unlike some other imaging methods. No major reports of negative side effects from using ultrasound for breast imaging have emerged, indicating it is generally safe for most people. Overall, ultrasound is a dependable and safe tool in the fight against breast cancer.12345

Why are researchers excited about this trial?

Researchers are excited about the Spot Compression Ultrasound technique because it offers a more targeted approach to detecting breast lumps compared to traditional mammography. This method applies focused ultrasound pressure to specific areas of the breast, potentially increasing the accuracy of detecting abnormalities. By honing in on precise regions, this technique might reduce false positives and unnecessary biopsies, which are common issues with current imaging methods. Additionally, the non-invasive nature of ultrasound makes it a safer option with no radiation exposure, making it a promising alternative for breast lump detection.

What evidence suggests that this ultrasound technique is effective for breast lump detection?

Research has shown that ultrasound effectively diagnoses breast conditions, with studies indicating about 90% accuracy in nearly 2,000 patients. It is especially reliable for women with dense breast tissue. This trial will evaluate the effectiveness of a method called "ultrasound in the grid," which participants will receive as part of the Spot Compression Ultrasound arm. Recent studies suggest that this method might improve the detection of breast lumps when used alongside mammograms, helping doctors confidently match findings between mammograms and ultrasounds. Overall, ultrasound is a promising option for finding breast lumps, especially since it doesn't involve radiation exposure.678910

Who Is on the Research Team?

EL

Eun L Langman, MD

Principal Investigator

Duke Health

Are You a Good Fit for This Trial?

This trial is for people with a breast lump that can be seen on both a diagnostic mammogram and an ultrasound, where the lump is smaller than 3 cm so it fits within the special imaging paddle.

Inclusion Criteria

Mass visible on both diagnostic mammogram and ultrasound
Mass within the size limit to be completely confined within an open grid mammogram paddle (less than 3 cm)

Exclusion Criteria

No specific requirements apply to me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging Procedure

Participants undergo spot compression ultrasound and standard diagnostic breast ultrasound

Single visit, up to approximately one hour
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Targeted ultrasound in the grid

Trial Overview

The study compares a new targeted breast ultrasound technique done during mammogram compression (using an open grid paddle) to standard breast ultrasound, looking at how well each finds lumps and how long each takes.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Spot Compression UltrasoundExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

Citations

Spot Compression Ultrasound Compared to Traditional ...

The purpose of this study is to determine the efficacy of targeted breast ultrasound ("ultrasound in the grid") performed concurrently with ...

Targeted Breast Ultrasound versus Standard ...

This study focuses on comparing the effectiveness of a new breast examination method, 'ultrasound in the grid', performed during mammogram breast compression, ...

Evaluating the Role of Breast Ultrasound in Early Detection of ...

This review analyzes the possibility of breast ultrasound as a primary screening modality for breast cancer, particularly in resource-limited areas.

Breast Cancer Screening Tool Avoids Radiation, ...

This article addresses the emerging use of adjuncts, such as 3D ultrasound, in breast cancer screening.

Breast Ultrasound: Everything You Need to Know

A breast ultrasound is a safe, noninvasive procedure that doesn't expose you to radiation or cause side effects. However, it isn't 100 percent accurate, as ...

Ultrasound for Breast Cancer Detection Globally - PMC - NIH

When the available data from low-resource countries were considered, ultrasound maintained a diagnostic sensitivity of 89.25% and specificity of 99.1%.

Adjunct Automated Breast Ultrasound in Mammographic ...

Adding ABUS to mammography increased sensitivity by 6–35 percentage points and improved cancer detection by 2.4–4.3 per 1000 women with dense breasts, with ...

Ultrasound Imaging and Breast Cancer Screening

Ultrasound imaging is widely used for early breast cancer screening to enhance patient survival. However, interpreting these images is inherently ...

Role of Breast Ultrasound for the Detection and Differentiation ...

Ultrasound is useful to examine dense breast tissue. Recent studies have shown that the detection of small cancers with high-resolution ultrasound is increased.

Breast Cancer Detection Using Automated ...

Background: Automated Breast Ultrasound technology. (ABUS) allows the radiologist to interpret ultrasonography images in a separate time after acquisition.