NCT05337280

OA for Breast Cancer NAC Response

Feasibility of Assessing Breast Cancer Neoadjuvant Therapy Response Using Imagio Opto-Acoustic Imaging

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Seno Medical Instruments Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an early research and development study. The objective of this study is to determine the feasibility of the Imagio OA/US Breast Imaging System to detect complete breast cancer pathologic response to neoadjuvant therapy as assessed by functional optoacoustic features, vascular features and relative degrees of oxygenation/deoxygenation

Detailed description

The use of neoadjuvant systemic therapy in the treatment of breast cancer patients is increasing beyond the scope of locally advanced disease. Imaging provides important information in assessing response to therapy as a complement to conventional tumor measurements via physical examination. Tumor response to neoadjuvant therapy can also provide prognostic information. As stated in the background section, the attainment of pCR after completion of neoadjuvant therapy and surgical resection is associated with improved disease-free survival \[1-3\]. This correlation is especially strong for Triple-receptor negative (ER, PR negative and HER-2 non amplified), and HER-2 positive breast cancer. Studies of neoadjuvant therapy have used a variety of methods for assessing tumor response. Currently, there are no established clinical practice guidelines for how best to assess tumor response to neoadjuvant therapy. Typically, patients undergo conventional breast imaging (mammography and US) and physical examination, and DCE-MRI in selected cases. The Imagio OA/US technology is an alternative imaging technology that demonstrates both gray scale ultrasound morphologic information, including size measurements, and functional information that includes presence or absence of tumor angiogenesis, degree of angiogenesis, and relative degrees of oxygenation and deoxygenation of hemoglobin.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Imagio OA/US	Imagio optoacoustic/ultrasound

Timeline

• Start date: 2021-03-30
• Primary completion: 2023-01-04
• Completion: 2023-01-04
• First posted: 2022-04-20
• Last updated: 2023-04-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study