Ultrasound Techniques for Nipple Imaging

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Breast cancer, Breast symptom, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best ways to use ultrasound, a type of imaging test, to capture clear images of the nipple and surrounding area. The goal is to identify the most effective techniques for diagnostic imaging. It is ideal for healthy women with no history of breast cancer or breast-related symptoms. Participants will undergo a non-invasive ultrasound scan lasting about an hour. As an unphased trial, it allows participants to contribute to advancing imaging techniques without requiring prior breast health issues.

Do I need to stop my current medications for this trial?

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

What prior data suggests that these ultrasound techniques are safe for imaging the nipple areolar complex?

Research has shown that ultrasound scans, like those used in this study, are generally easy for people to handle. Ultrasound is a non-invasive method, meaning it doesn't involve surgery or entering the body. It uses sound waves to create images of the body's interior.

No major safety concerns have been reported for using ultrasound on the nipple area. This technique resembles the ultrasounds performed during pregnancy, and there are no known harmful effects from these types of scans.

In this study, participants will undergo about an hour of scanning. Ultrasound is typically painless and should not cause any discomfort. In summary, based on similar uses, the procedure appears safe for people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ultrasound technique for nipple imaging because it offers a non-invasive way to examine the nipple and surrounding tissues. Unlike traditional imaging methods like mammography or MRI, this approach uses sonography, which doesn’t involve radiation and is typically more comfortable for patients. This method aims to provide detailed images that could improve early detection and monitoring of breast health without the discomfort or risks associated with more invasive procedures.

What evidence suggests that ultrasound techniques are effective for nipple imaging?

Research has shown that ultrasound is a helpful tool for imaging the nipple area. Studies have found that ultrasound provides clear pictures of the tissues just under the skin. This is particularly useful because ultrasound does not use harmful radiation, making it safer for repeated use. In this trial, healthy volunteers will undergo non-invasive ultrasound scanning of the nipple and its adjacent tissues to further explore its effectiveness. Past studies demonstrated that ultrasound, along with other imaging methods, helped predict if cancer might affect the nipple. Overall, ultrasound is a promising method for diagnosing issues in the nipple area. ^{3 4 6 7 8}

Who Is on the Research Team?

Christine Lee, MD, PhD

Principal Investigator

Mayo Clinic

Shigao Chen, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This clinical trial is open to healthy individuals who are interested in participating in a study focused on improving ultrasound imaging techniques of the nipple areolar complex (NAC).

Inclusion Criteria

I am a woman over 18 with no breast cancer history or current symptoms.

Exclusion Criteria

Vulnerable subjects such as prisoners

I am unable to give consent by myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Ultrasound Scanning

Participants undergo 1 hour of non-invasive ultrasound scanning of the nipple and its adjacent tissues

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sonography of the Nipple Areolar Complex

Trial Overview The study is testing different ultrasound scanning methods using various thicknesses of conventional ultrasound coupling gel and pads to find out which provides the best diagnostic images of the NAC.

How Is the Trial Designed?

Group I: Healthy Subjects Experimental Treatment 4 Interventions

Healthy volunteers with no breast cancer or breast symptoms. Subjects will undergo 1 hour of non-invasive ultrasound scanning of the nipple and its adjacent tissues.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6774590/

Use of preoperative mammography, ultrasonography, and ... Imaging findings on preoperative mammography, ultrasonography and MRI are effective predictors for nipple involvement by cancer. Advances in knowledge:.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7406635/

Multimodality approach to the nipple-areolar complex In addition to being widely available and not requiring ionizing radiation, ultrasound provides good spatial resolution of this superficial ...

3. clinicalradiologyonline.net clinicalradiologyonline.net/article/S0009-9260(20)30405-0/fulltext

The nipple–areolar complex: comprehensive imaging review This article provides a review of the normal anatomy, common anatomical variants, benign and malignant pathologies, and imaging techniques to guide the ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0009926020304050

The nipple–areolar complex: comprehensive imaging review This article provides a review of the normal anatomy, common anatomical variants, benign and malignant pathologies, and imaging techniques to guide the ...

5. researchgate.net researchgate.net/publication/44626500_The_Nipple-Areolar_Complex_A_Pictorial_Review_of_Common_and_Uncommon_Conditions

The Nipple-Areolar Complex A Pictorial Review of ... We evaluated the imaging findings of nipple-areolar complex lesions, using multiple breast imaging modalities including mammography, sonography ...

6. umbjournal.org umbjournal.org/article/S0301-5629(24)00047-4/fulltext

SONOGRAPHIC EVALUATION AND VARIOUS DISEASES ... Calcifications may develop in the nipple areolar complex in some patients and typically are benign. • Calcifications may occur in the skin of the areola ...

7. insightsimaging.springeropen.com insightsimaging.springeropen.com/articles/10.1186/s13244-020-00896-1

Multimodality approach to the nipple-areolar complex The nipple-areolar complex requires a specific imaging workup in which a multimodal approach is essential. Radiologists need to know the ...

8. ajronline.org ajronline.org/doi/abs/10.2214/AJR.12.9186

Malignant Invasion of the Nipple-Areolar Complex of the Breast OBJECTIVE. The objective of our study is to assess the usefulness of breast MRI for the evaluation of malignant invasion of the nipple-areolar complex.