OA for Breast Cancer NAC Response

• ClinicalTrials.gov Identifier: NCT05337280
• Recruitment Status: Recruiting
• First Posted: April 20, 2022
• Last Update Posted: April 27, 2022
• Sponsor: Seno Medical Instruments Inc.
• Collaborator: American College of Radiology
• Information provided by (Responsible Party): Seno Medical Instruments Inc.

Study Description

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

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Device: Imagio OA/US	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Intervention Model Description: This is a single center sequential design
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Feasibility of Assessing Breast Cancer Neoadjuvant Therapy Response Using Imagio Opto-Acoustic Imaging
• Actual Study Start Date: March 30, 2021
• Estimated Primary Completion Date: June 2023
• Estimated Study Completion Date: June 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Imagio OA/US; Imagio OA/US Imaging	Device: Imagio OA/US; Imagio optoacoustic/ultrasound

Outcome Measures

Primary Outcome Measures :

1. The number of masses that may exhibit qualitative changes in accordance with Functional Feature Scale as assessed by Imagio OA/US over the course of baseline though follow-up timepoints [ Time Frame: Baseline to Post Surgical Assessment at 6 months ]
   Feature scores per mass derived per Feature Score Scale (0-6 and 0-5 scoring- lower score mean most likely benign) per 5 mass features (External Peripheral Zone, External Capsular Boundary, Internal Shape, Internal Echotexture, Internal Sound ) used to predict number of masses that demonstrated response or no response at all time points (baseline, cycle 2, mid cycle and pre surgical) to chemotherapy treatment
2. Number of masses that correlate with chemotherapy response/no response as assessed by Functional Feature Score Scale at all study timepoints to predict optimal timing for Imagio imaging [ Time Frame: Baseline to Post Surgical Assessment at 6 months ]
   Number of masses assessed at baseline and follow-up timepoints - cycle 2, mid cycle and pre surgical f/u that correlate with feature score (External Peripheral Zone, External Capsular, Internal Vessel Score, Internal Total Hemoglobin, Internal Deoxygenated Blush) changes assessed by Feature Score Scale (0-6 nd 0-5 scores depending on feature) and pathologic complete response (pCR) to determine optimal timing for imaging.

Other Outcome Measures:

1. Number of metastatic lymph nodes scored using a Lymph Node Scoring Scale that may correlate with chemotherapy response [ Time Frame: Baseline to Post Surgical Assessment at 6 months ]
   Imagio OA/US imaging of metastatic lymph nodes will be assessed using a designated Lymph Node Scale (Shape Score, Cortical Thickness, Margin Score and Hilar Compression Score, Size Score) to predict response(0 = benign / 1 = benign, uncertain / 2-4 = probably malignant / >=5 = malignant) to chemotherapy

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Shaan Schaeffer, BA; 6106983259; sschaeffer@senomedical.com

Locations

United States, Texas

UT Southwestern; Recruiting

Dallas, Texas, United States, 75390

Contact: Basak Dogan, MD 214-645-3290 basak.dogan@utsothwestern.edu

Contact: Keshia Anerobi 214-648-5982 keshia.anerobi@utsouthwestern.edu

Principal Investigator: Basak Dogan, MD

Sponsors and Collaborators

Seno Medical Instruments Inc.

American College of Radiology

Investigators

• Principal Investigator: Basak Dogan, MD; UT Southwestern

More Information

• Responsible Party: Seno Medical Instruments Inc.
• ClinicalTrials.gov Identifier: NCT05337280
• Other Study ID Numbers: NEO-01
• First Posted: April 20, 2022
• Last Update Posted: April 27, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases