OA for Breast Cancer NAC Response

NCT ID: NCT05337280

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-30
• Study Completion Date: 2023-01-04

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Imagio OA/US

Imagio OA/US Imaging

Group Type: EXPERIMENTAL

Imagio OA/US

Intervention Type: DEVICE

Imagio optoacoustic/ultrasound

Interventions

Imagio OA/US

Imagio optoacoustic/ultrasound

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 18 years and older male or female patients;

2. Ipsilateral intact biopsy-proven invasive breast cancer clinical T1-T4 (by standard of care imaging), including primary or recurrent disease.

3. Patient eligible to receive neoadjuvant chemotherapy

Exclusion Criteria

1. Known Stage IV disease (breast or other cancer);

2. Have a condition or impediment (i.e., insect bites, poison ivy, open sores, chafing of the skin, scar, tattoos, moles, etc.); that could interfere with the intended field of view (within one probe length or 4 cm of the nodule);

3. Patient has received chemotherapy for any type of cancer within 90 days from date of baseline Imagio OA/US exam;

4. Is experiencing photo-toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as sulfa, ampicillin, tetracycline;

5. Is currently undergoing phototherapy;

6. Has a history of any photosensitive disease (e.g., porphyria, lupus erythematosus);

7. Is undergoing treatment for a photosensitive disease and is experiencing photosensitivity;

8. Pregnancy;

9. Patient has participated in a clinical study of an investigational drug or device within 3 months prior to screening visit that may have an impact on clinical outcomes.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American College of Radiology

OTHER

Sponsor Role: collaborator

Seno Medical Instruments Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Basak Dogan, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern

Locations

UT Southwestern

Dallas, Texas, United States

Countries

United States

Other Identifiers

NEO-01

Identifier Type: -

Identifier Source: org_study_id